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– TiNivo-2 FOTIVDA^® (tivozanib) monotherapy (control arm) results provide clinically meaningful efficacy and safety data following front-line immune checkpoint inhibitor (ICI) combinations –

– TIVO-3 Exploratory Overall Survival (OS) Analysis Provides Additional Data for FOTIVDA Following Immunotherapy –

– Safety results support the well-established safety profile of FOTIVDA –

BOSTON, September 16, 2024 (PR Newswire) — AVEO Oncology, an LG Chem company (“AVEO”), announced today that the TiNivo-2 Phase 3 clinical trial results in patients with advanced metastatic renal cell carcinoma (RCC) whose tumors had progressed following prior ICI treatment were presented at the 2024 European Society of Medical Oncology (ESMO) congress September 13-17 in Barcelona, Spain. Additionally, a follow up exploratory analysis from TIVO-3, FOTIVDA’s pivotal trial, was also presented during the conference.

The TiNivo-2 clinical trial was designed to evaluate the treatment of FOTIVDA, a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), in combination with nivolumab, a PD-1 inhibitor, versus FOTIVDA as a single agent therapy to investigate the benefit of ICI challenge in a relapsed refractory setting.

Toni Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology, Director of the Kidney Cancer Center at Dana-Farber Cancer Institute, Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, and lead investigator presented the first analysis of the TiNivo-2 study results at ESMO. The addition of nivolumab to FOTIVDA (0.89 mg) following prior immunotherapy did not enhance efficacy over FOTIVDA (1.34 mg) alone (hazard ratio 1.10 [95% confidence interval, 0.84-1.43; P=0.49]); as such the study did not meet its primary endpoint. In pre-planned analyses of the FOTIVDA control arm, a 9.2 month median progression free survival (PFS) was observed for patients that received FOTIVDA monotherapy as second line and for patients immediately following ICI combination therapy; the experimental arm (nivolumab plus tivozanib) had a 7.3 month median PFS in the second line and a 7.4 month median PFS for patients immediately following ICI combination therapy.

The TiNivo-2 study results add to the existing body of data in RCC suggesting there is no clinical benefit derived from rechallenging patients with immunotherapy beyond progression on previous ICIs.

“We are truly grateful for the patients who participated in TiNivo-2 so that we can continue to make evidence-based advancements in RCC treatment and patient care,” says Michael P. Bailey, AVEO Oncology Chief Executive Officer and President. “We are excited to share the comprehensive TiNivo-2 dataset with the oncology community; these data provide additional support on the use of FOTIVDA as an option in the second line following frontline immunotherapy combination treatment.”

Dr. Choueiri comments, “The PFS results in the intent-to-treat population demonstrate the activity of tivozanib in the 2^nd and 3^rd lines following front line immunotherapy. The safety results were also consistent with the safety profile observed in TIVO-3.”

In conjunction with the scientific presentation, the TiNivo-2 data were simultaneously published in the prestigious journal, The Lancet.

In addition to the TiNivo-2 data presentation, an exploratory long-term follow up analysis from the TIVO-3 study was presented by Dr. Miguel Zugman of the City of Hope Comprehensive Cancer Center at ESMO 2024. Although the post hoc analysis did not reach statistical significance, the data indicates that tivozanib trended toward improved OS compared to sorafenib, in the subset of patients previously treated with checkpoint inhibitors. The OS hazard ratio in the checkpoint inhibitor-treated subset was 0.69 (95% confidence interval, 0.43-1.11) favoring tivozanib. 

TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors have progressed following prior ICI therapy.

TIVO-3 Clinical Trial Details
TIVO-3 was a Phase 3, global, open-label, parallel-arm study comparing the safety and efficacy of FOTIVDA versus sorafenib in patients with relapsed refractory advanced RCC whose disease progressed with two or three prior systemic regimens including at least one VEGFR TKI.

About FOTIVDA
FOTIVDA is an oral, next-generation VEGFR TKI. It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA^® (tivozanib).

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA in the U.S. for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com.

References

1. ClinicalTrials.gov. Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma. Accessed July 12, 2024. https://clinicaltrials.gov/ct2/show/NCT04987203
2. FOTIVDA (tivozanib)[https://www.fotivda.com/fotivdapi.pdf].Boston, MA: AVEO Pharmaceuticals, Inc.
3. OPDIVO (nivolumab)[https://packageinserts.bms.com/pi/pi_opdivo.pdf ].Princeton, NJ: Bristol-Myers Squibb Company.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714

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BOSTON, September 3, 2024 (PR Newswire) – AVEO Oncology, an LG Chem company (“AVEO”), announced today their late-breaking abstract detailing their Phase 3 TiNivo-2 trial has been selected as a Proffered Paper oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain this September 13-17^th.

The oral presentation will announce the results from the TiNivo-2 clinical trial, which was designed to evaluate the benefit of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose (0.89mg) FOTIVDA^® (tivozanib), a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) versus standard dose (1.34mg) FOTIVDA in the second-line following immune checkpoint inhibitor (ICI) combinations or the third-line setting following prior ICI treatment. Details of the presentation are as follows:

Title:	Tivozanib Plus Nivolumab vs Tivozanib Monotherapy in Patients With Metastatic Renal Cell Carcinoma Following an Immune Checkpoint Inhibitor: Results of the Phase 3 TiNivo-2 Study
Speaker:	Toni Choueiri, MD, Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute, Boston, MA, United States of America
Presentation #:	LBA73
Category:	Proffered Paper session 1: GU tumors, non-prostate
Date & Time:	Friday, September 13, 2024; 2:00 – 2:10 pm CET

TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors  progressed following prior ICI therapy.

About FOTIVDA^® (tivozanib)
FOTIVDA^® (tivozanib) is an oral, next-generation VEGFR TKI. It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA® (tivozanib).

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA in the U.S. for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting- edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com.

References

1. ClinicalTrials.gov. Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma. Accessed July 12, 2024. https://clinicaltrials.gov/ct2/show/NCT04987203
2. FOTIVDA (tivozanib)[https://www.fotivda.com/fotivdapi.pdf].Boston, MA: AVEO Pharmaceuticals, Inc.
3. OPDIVO (nivolumab)[https://packageinserts.bms.com/pi/pi_opdivo.pdf ].Princeton, NJ: Bristol-Myers Squibb Company.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714

SOURCE AVEO, an LG Chem company

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– The addition of nivolumab to low dose tivozanib after prior immune checkpoint inhibitor (ICI) is not superior to standard dose tivozanib alone; as a result, the primary endpoint was not met –

– Tivozanib monotherapy (control arm) results provide clinically meaningful efficacy and safety data following front-line ICI combinations –

– Safety results reinforce tivozanib is well-tolerated –

– Data to be submitted to upcoming scientific meeting –

BOSTON, July 18, 2024 (PR Newswire) — AVEO Oncology, an LG Chem company (“AVEO”), announced today that the TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma (RCC) whose tumors had progressed following prior immune checkpoint inhibitor (ICI) treatment did not meet the primary endpoint of increasing progression free survival (PFS) when nivolumab was added to low dose (0.89 mg) FOTIVDA^® (tivozanib). Importantly, the clinical trial’s control arm using FOTIVDA as monotherapy at the standard dose (1.34 mg) demonstrated a clinically meaningful outcome in median PFS in the second-line following ICI combination therapy. These results build on the prior ICI dataset from the TIVO-3 clinical trial, FOTIVDA’s pivotal phase 3 study, and further support the approved use of FOTIVDA as a safe and effective treatment option in relapsed or refractory advanced RCC following two or more prior systemic therapies.

The results from the TiNivo-2 clinical trial are consistent with other recent RCC phase 3 trials in a similar patient population, making this the second phase 3 clinical trial to suggest that there is no clinical benefit derived from rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs.

“The PFS and safety of the FOTIVDA control arm in the second-line following ICI combinations adds to the growing body of evidence of the importance of a highly selective anti-VEGFR TKI therapy as an effective, well-tolerated treatment option for relapsed or refractory RCC patients treated with prior ICI combination therapy,” says Michael P. Bailey, AVEO Oncology Chief Executive Officer and President. “While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations.”

Toni Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology, Director of the Kidney Cancer Center at Dana-Farber Cancer Institute, Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, and lead investigator comments, “The PFS and safety results from the control arm support tivozanib as an effective and well-tolerated treatment option in the second-line following an ICI combination as prior systemic therapy.”

The TiNivo-2 clinical trial was designed to evaluate the benefit of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose FOTIVDA versus standard dose FOTIVDA in the second-line following ICI combinations or the third-line setting following prior ICI. The TiNivo-2 clinical trial enrolled patients across clinical sites in North America, Latin America, and Europe. Patients with RCC who progressed after receiving immunotherapy were randomized to either tivozanib single agent or in combination with nivolumab. The trial’s primary outcome was progression free survival; secondary endpoints included overall survival, overall response rate, duration of response, and safety.

Detailed findings are expected to be presented at an upcoming medical meeting.

TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors have progressed following prior immune checkpoint inhibitor therapy, known as the TiNivo-2 trial.

About FOTIVDA^® (tivozanib)
FOTIVDA^® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension and Hypertensive Crisis: Hypertension was reported in 45% of FOTIVDA-treated patients with 22% of the events ≥Grade 3. Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed.

Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac Failure: Cardiac failures were reported in 1.6% of FOTIVDA-treated patients, with 1% of events reported as ≥Grade 3; 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac Ischemia and Arterial Thromboembolic Events: Cardiac ischemia in FOTIVDA-treated patients were reported in 3.2%; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of FOTIVDA-treated patients, including death due to ischemic stroke (0.1%). Closely monitor patients who are at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events: Venous thromboembolic events were reported in 2.4% of FOTIVDA-treated patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue FOTIVDA in patients who develop serious venous thromboembolic events.

Hemorrhagic Events: Hemorrhagic events were reported in 11% of FOTIVDA-treated patients; 0.2% of events were fatal. FOTIVDA should be used with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria: Proteinuria was reported in 8% of FOTIVDA-treated patients, with 2% Grade 3. Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment with FOTIVDA. Discontinue FOTIVDA in patients who develop nephrotic syndrome.

Thyroid Dysfunction: Thyroid dysfunction events were reported in 11% of FOTIVDA-treated patients, with 0.3% of events reported as ≥Grade 3. Monitor thyroid function before initiation and throughout treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery. Do not administer FOTIVDA for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by MRI, can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) as an imprint ink which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most commonly reported (≥20%) adverse reactions were: fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. Serious adverse reactions reported in >2% of patients included bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during FOTIVDA treatment and for at least 1 month after the last dose.

Renal Impairment: The recommended dosage for patients with end-stage renal disease has not been established.

Hepatic Impairment: Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA^® (tivozanib).

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA^® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversi½ed business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting- edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com.

References

1. ClinicalTrials.gov. Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma. Accessed July 12, 2024. https://clinicaltrials.gov/ct2/show/NCT04987203
2. FOTIVDA (tivozanib)[https://www.fotivda.com/fotivdapi.pdf].Boston, MA: AVEO Pharmaceuticals, Inc.
3. OPDIVO (nivolumab)[https://packageinserts.bms.com/pi/pi_opdivo.pdf ].Princeton, NJ: Bristol-Myers Squibb Company.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714

Source: AVEO Pharmaceuticals, Inc.

Download PDF

– LG Chem to embark on developing Next-Generation Immune Checkpoint Inhibitors to Provide Solid Tumor Treatment Solutions –

– LG Chem and AVEO Oncology continuing to advance its shared vision of becoming a leading global oncology company –

BOSTON, June 13, 2024 (PR Newswire) — LG Chem and AVEO Oncology, an LG Chem company, announced that it has enrolled the first patient in the United States for a Phase 1 clinical study of LB-LR1109 (NCT06332755; LG project code LR19155), LG Chem’s first proprietary anti-cancer investigational drug candidate. LG Chem will be collaborating closely with AVEO Oncology, its wholly owned subsidiary, that specializes in oncology development and commercialization, to advance strategies for late-stage clinical development and regulatory approval.

This is a Phase 1, multi-center, open-label, non-randomized, dose escalation study designed to determine the recommended Phase 2 dose of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of LB-LR1109, and its potential impact on quality of life. The study is evaluating participants with unresectable and metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have progressed on standard of care treatment options.

In preclinical studies of LB-LR1109, LG Chem observed dose-dependent anti-cancer effects. Subsequently, the company received approval for an Investigational New Drug application from the U.S. Food and Drug Administration (FDA) in December last year.

Leukocyte Immunoglobulin Like Receptor B-1 (LILRB1), a protein released by cancer cells to prevent immune cell attacks, is commonly expressed on the surfaces of several immune cells, including T cells, natural killer cells (NK cells), and macrophages (phagocytic cells). This mechanism is believed to work by activating the tumor-eradicating cells such as T cells, NK cells, and macrophages simultaneously.ⁱ This simultaneous activation of overall immune cell functions may differentiate it from existing therapies that focus on single immune cells like T cells.

“We are excited to partner with LG Chem on their first proprietary anti-cancer compound,” said Dr. Alex Spira, Director of Next Oncology of Virginia Cancer Specialists Research Institute and the Phase 1 Trial Program. “There is a high unmet need for patients that have progressed on standard of care treatment which necessitates the need to explore novel immune checkpoint inhibitors such as LB-LR1109.” 

Jeewoong Son, MD, President of LG Chem Life Sciences Company, stated, “We are focusing all our capabilities to provide innovative treatments that will be recognized by medical professionals and patients, as we aim to improve the lives of patients with cancer. While this is the first oncology compound from LG Chem, we are developing a robust pipeline that target novel oncology targets.  We will continue to offer differentiated treatment options in the oncology field, where there is the greatest unmet medical need.”

The advancement of this program into the clinic brings LG Chem and AVEO Oncology one step closer to realizing our vision of becoming one of the world’s leading oncology companies with a robust clinical pipeline of innovative therapies.

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immunooncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. For more information, please visit www.aveooncology.com.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com.

Contacts Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714
Source: AVEO Pharmaceuticals, Inc.

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ⁱ Zeller T, Münnich IA, Windisch R, et al. Perspectives of targeting LILRB1 in innate and adaptive immune checkpoint therapy of cancer. Front Immunol. Published online September 13, 2023.
doi:10.3389/fimm.2023.1240275

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– Industry veteran brings extensive clinical development experience to AVEO Oncology leadership
team as Chief Medical Officer –

– Formation of a Scientific Advisory Committee from world-renowned cancer institutions –

BOSTON, March 28, 2024 (GLOBE NEWSWIRE) — In a release issued under the same headline on March 25 by AVEO Pharmaceuticals, the text in the second paragraph has been corrected to better reflect Dr. Braendle’s clinical research experience. The corrected release follows:

AVEO Oncology (“AVEO”), an LG Chem company, today announced the appointment of Edgar E. Braendle, MD, PhD as AVEO Oncology’s new Chief Medical Officer. Dr. Braendle is a life sciences executive with experience spanning from early drug discovery to the launch of small molecules, biologics, radiopharmaceuticals, gene and cell therapies, and medical device development.

Dr. Braendle brings more than twenty years of clinical research experience to AVEO Oncology, most recently serving as Chief Development Officer of Autolus Therapeutics Plc since July 2021, where he was responsible for all development functions and the conduct of a pivotal program in CD-19 directed genetically modified autologous T cell immunotherapy for adult acute lymphoblastic leukemia, and the respective filing to the U.S. Food & Drug Administration and European Medicines
Agency.

“We are delighted to have Dr. Braendle join the AVEO Oncology team particularly at this important juncture as we seek to become a global top 20 oncology leader,” said Michael P. Bailey, President and Chief Executive Officer of AVEO Oncology, an LG Chem company. “Dr. Braendle’s significant experience will be instrumental in our efforts to develop and diversify our pipeline.”

Prior to his time at Autolus, Dr. Braendle held the role of Executive Vice President, Chief Medical Officer and Global Head of Development at Sumitomo Dainippon Pharma Oncology, where he was responsible for a full range of development functions and progressed several early-stage, first in human programs and late-stage programs. Prior to this, Dr. Braendle served as President and CEO of ARUP Laboratories, a national clinical and anatomic reference laboratory. Dr. Braendle also spent over a decade at Novartis AG, where he served as Senior Vice President and Global Head of Companion Diagnostics and led the company’s precision medicine approach. Dr. Braendle received his medical degree at RWTH Aachen University in Germany, followed by specialty training in medical oncology, urology and pharmacology. Dr. Braendle is also an associate professor at the University of Ulm, Germany.

Today, AVEO Oncology, an LG Chem company, and LG Chem Life Sciences also announced the formation of its Scientific Advisory Committee (“Committee”). This esteemed group of experts in oncology research and clinical development were selected to advise and bring unique perspectives to AVEO and LG Chem’s clinical strategy and business development initiatives. “We are excited and privileged to have the opportunity to work with this group of top oncology experts to help guide our drug development initiatives from discovery through commercialization. Notably, the Committee represents key areas of interest including gastrointestinal, genitourinary, ovarian, lung and head and neck cancers,” said Mr. Bailey.

The Scientific Advisory Committee is comprised of several leading cancer experts, including:

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immunooncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. For more information, please visit www.aveooncology.com.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com.

Contacts Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714
Source: AVEO Pharmaceuticals, Inc.

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BOSTON, Feb. 06, 2024 (GLOBE NEWSWIRE) — AVEO Oncology, an LG Chem company (“AVEO”), today announced The Oncologist has published a post-hoc analysis of long-term progression free survival, overall survival and safety data from the Phase 3 TIVO-3 trial evaluating FOTIVDA® (tivozanib) in patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC). In the publication, FOTIVDA demonstrated a consistent safety profile and a long-term survival benefit in patients who were alive and progression-free at 12 months, suggesting a durable clinical benefit and safety across age groups regardless of prior treatment.

“The post-hoc analysis from TIVO-3 provides additional evidence supporting the clinical utility of tivozanib in the third- or fourth-line refractory setting in patients with advanced renal cell carcinoma,” said lead author Kathryn E. Beckermann, MD, PhD, Assistant Professor of Medicine in the Division of Hematology Oncology at Vanderbilt-Ingram Cancer Center. “The results suggest there is a clinically meaningful population of patients who can experience a long-term survival benefit from tivozanib over sorafenib.”

TIVO-3 compared the efficacy and safety of the vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) FOTIVDA and sorafenib (Nexavar®) in patients with R/R advanced RCC whose disease progressed with two or three prior systemic therapies. The trial included a predefined subgroup of patients (26%) who were previously treated with both an immuno-oncology (IO) therapy and a VEGFR TKI.

The post hoc analysis showed investigator-assessed landmark long-term progression-free survival (PFS) rates were higher with FOTIVDA compared to sorafenib (3 years: 12.3% vs. 2.4%; 4 years: 7.6% vs. 0%). After 22.8 months mean follow-up, the overall survival (OS) hazard ratio (HR) for FOTIVDA was 0.89 (95% confidence interval [CI]: 0.70-1.14); when conditioned on a clinically meaningful 12-month PFS time point, FOTIVDA showed significant improvement in OS compared to sorafenib (HR: 0.45; 95% CI: 0.22-0.91; 2-sided P = 0.0221). Mean time on treatment was 11.0 months with FOTIVDA and 6.3 months with sorafenib. There were fewer treatment-related adverse events (TRAEs) and lower dose modification rates with FOTIVDA than with sorafenib as well as fewer grade ≥3 TRAEs on FOTIVDA (46%) than sorafenib (55%). Dose modification rates were lower with FOTIVDA than with sorafenib across age and prior IO subgroups; and prior IO therapy did not impact dose reductions or discontinuations in either arm.

The advent of targeted therapies and IO therapies is considered a major advancement in the treatment of RCC, and IO-based combination therapy is the frontline standard of care for patients with advanced RCC who require systemic therapy.⁴ However, despite the demonstrated benefits of IO combination therapies, most patients with RCC ultimately experience disease progression and require subsequent treatments⁵, underscoring the need for safe, tolerable and effective therapies in the refractory setting.

“For patients with relapsed or refractory advanced renal cell carcinoma, long-term progression-free survival is a vital measure of the value of anticancer therapy,” commented Michael Bailey, President and CEO of AVEO Oncology. “The long term PFS analysis combined with the post hoc conditional survival analysis is especially encouraging in this highly refractory population, as it builds upon the previously reported PFS advantage for FOTIVDA over sorafenib, a non-selective VEGFR TKI.”

Study Details

TIVO-3 was a Phase 3, global, open-label, parallel-arm study comparing the safety and efficacy of FOTIVDA versus sorafenib in patients with R/R advanced RCC whose disease progressed with two or three prior VEGFR TKI systemic regimens. The trial randomized 350 patients to receive FOTIVDA (1.5 mg once daily) or sorafenib (400 mg twice daily). The intent-to-treat (ITT) population included 175 patients in each arm; the safety population included 173 patients in the FOTIVDA arm and 170 in the sorafenib arm.

About FOTIVDA® (tivozanib)

FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.⁶ FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTION

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding. Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.AVEOoncology.com.

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit www.lgchem.com

References
American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-factsfigures.html.
² Tran J. Ornstein MC. Clinical review on the management of metastatic renal cell carcinoma. JCO Oncol Pract. 2021;18(3):187-196. https://ascopubs.org/doi/10.1200/OP.21.00419.
³ Bergstrom A, Hsieh CC, Lindblad P, et al. Obesity and renal cell cancer – a quantitative review. Br J Cancer. 2001;85(7):984-990. https://www.nature.com/articles/6692040.
⁴ Tenold M, Ravi P, Kumar M, et al. Current approaches to the treatment of advanced or metastatic renal cell carcinoma. Am Soc Clin Oncol Educ Book. 2020;40:1-10. https://ascopubs.org/doi/10.1200/EDBK_279881.
⁵ Vento JA, Rini BI. Treatment of refractory metastatic renal cell carcinoma. Cancers (Basel). 2022;14(20):5005. doi: 10.3390/cancers14205005.
⁶ Pawlowski N, Hoerzer H, Singh-Jasuja H, Hilf N. Impact of various first- and second-generation tyrosine-kinase inhibitors on frequency and functionality of immune cells. Cancer Res. 2013;78(8_Suppl):3971. https://aacrjournals.org/cancerres/article/73/8_Supplement/3971/589572/Abstract-3971-Impact-ofvarious-
first-and-second.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(609) 241-7352

Son Junil / Kim Junam
lgchempr@lgchem.com

Source: AVEO Pharmaceuticals, Inc.

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• Phase 3 Registrational Trial Seeks to Improve Survival Outcomes in Underserved HPVnegative R/M Head and Neck Cancer Patient Population
• Trial Launch Follows FDA Fast Track Designation of Ficlatuzumab/cetuximab Combination for Treatment of Relapsed/Recurrent HNSCC

BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) — AVEO Oncology (“AVEO”), an LG Chem company, today announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Ficlatuzumab is AVEO’s investigational antibody that targets hepatocyte growth factor (HGF).

“The start of enrollment for the pivotal FIERCE-HN trial is an important milestone in the advancement of the combination of ficlatuzumab and cetuximab, as it brings us a step closer to offering a new potential therapy to a patient population that has limited effective treatment options available to them today,” said Michael Bailey, president and chief executive officer of AVEO Oncology. “We are excited about the potential to extend the survival for this population of cancer patients where a significant unmet need currently exists.”

The U.S. Food and Drug Administration designated the investigation of ficlatuzumab and ERBITUX® (cetuximab) a Fast Track development program for relapsed/recurrent HNSCC in September 2021. That designation followed AVEO’s June 2021 announcement of positive results from a randomized phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory, metastatic HNSCC. In that study, patients with HPV-negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated an overall response rate of 38% versus 0% in the HPV positive subgroup, including 13% of HPV-negative patients with complete responses.

“Despite the advent of immune checkpoint inhibitor therapy for recurrent and metastatic head and neck squamous cell carcinoma, few patients with advanced disease survive for longer than one year,” commented Julie E. Bauman, MD, MPH, director of the George Washington Cancer Center as well as associate dean of cancer and professor of medicine at the George Washington School of Medicine & Health Sciences. “We therefore approach the FIERCE-HN trial with a mix of urgency and optimism, as the combination of ficlatuzumab and cetuximab has the potential to expand the range of viable therapeutic options for this underserved population.”

About the FIERCE-HN Trial
The FIclatuzumab in combination with ERBITUX® (cetuximab) Clinical Evaluation in Head and Neck cancer patients (FIERCE-HN trial) is designed to initially compare the efficacy and safety of two dose levels of ficlatuzumab plus cetuximab and then will proceed to a registrational stage to compare the optimal dose level to a control arm of placebo plus cetuximab in participants with HPV-negative R/M HNSCC. The trial is open to adults with a primary diagnosis of R/M HNSCC. Eligible participants must have failed prior therapy with an anti-programmed cell death protein 1, also known as PD-1, or programmed cell death ligand 1, also known as PD-L1, immune checkpoint inhibitor and with platinum-based chemotherapy, administered in combination or sequentially. Failure of prior treatment may be due to disease progression or intolerance to treatment. The primary FIERCE-HN endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate, duration of response, safety and tolerability, and pharmacokinetics of the ficlatuzumab and cetuximab combination. AVEO aims to enroll 410 participants across the clinical trial’s three arms. For more details about the clinical trial, please visit clinicaltrials.gov (NCT06064877) or the FIERCE-HN trial website at www.fiercehn.com.

About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. The U.S. Food and Drug Administration designated as a Fast Track development program the investigation of ficlatuzumab and ERBITUX® (cetuximab) for relapsed/recurrent HNSCC in September 2021.

ERBITUX is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immunooncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences Innovation Center, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. For more information, please visit www.aveooncology.com.

About LG Chem, Ltd. and LG Chem Life Sciences
LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading
innovation. For more information, please visit www.lgchem.com.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(908) 227-4714

Source: AVEO Pharmaceuticals, Inc.

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Boston, MA (November 30, 2023) — For the second year in a row, AVEO Oncology, an LG Chem company, has earned a spot on the Boston Globe’s annual ‘Top Places to Work in Massachusetts’ list.  AVEO Oncology appears in the medium-sized company (100-249 employees) category.

“We are incredibly excited to be selected once again as one of Massachusetts’ ‘Top Places to Work’,” said Michael Bailey, President and CEO, AVEO Oncology.  “This recognition is particularly gratifying as it occurred after the acquisition of AVEO by LG Chem, a time that can be the most difficult transition for a company. I could not be more proud of the AVEO team for their continued pursuit of the patient-focused mission and vision and I couldn’t be more thankful for the LG Chem team for working so hard to ensure a smooth integration of the two companies.”

In October 2022, LG Chem announced it would acquire AVEO Oncology, and the deal officially closed in January 2023. Together, AVEO and LG Chem have a shared mission and vision to provide innovative solutions to improve cancer patients’ lives and to become a global leader in the oncology therapeutics market.

Top firms are selected for the Boston Globe’s prestigious ‘Top Places to Work’ list based on anonymous employee surveys about leadership, appreciation, benefits, corporate social responsibility and more.  Nearly 100,000 employees participated in the survey from over 380 companies.

In addition to a shared mission regarding oncology drug development, AVEO and LG Chem share a culture of community service.  At an all-employee meeting earlier this year, employees from both companies assembled and packed emergency kits to benefit southwest Florida residents affected by Hurricane Ian. AVEO is also passionate about giving back to the local community and is proud to have been the top corporate fundraiser for The Jimmy Fund and the Boston Red Sox’s “Strike Out Cancer” initiative for the last two years. This fundraiser supports patient care and revolutionary cancer research at Dana Farber Cancer Institute — causes that resonate closely with AVEO’s mission.

Other company core values include “most respectful interpretation” which fosters honest and collaborative communication, a sense of thoughtful urgency, integrity, goal orientation, and encouraging an engaging work environment. The personification of these core principles enhances AVEO’s vibrant, unified and purpose-driven corporate culture, which has been further validated by the Boston Globe’s ‘Top Places to Work’ recognition for a second year in a row.

“In my years with AVEO Oncology I have been privileged to participate in a common mission to help improve the lives of cancer patients and their families,” said Katie McCarthy, Sr. Manager, Marketing, AVEO Oncology.  “And, while our mission is extremely serious, we find time to have fun.”

In the wake of the global pandemic, coupled with an integration, the needs of AVEO’s employees have changed.  “We recognize this and have worked hard to provide flexibility, improved benefits, and an even greater sense of purpose,” said Deb Wall, Director, Human Resources, AVEO Oncology.  “It’s more than just managing remote versus in-office or hybrid working conditions – we understand that our employees need more – more flexibility, more support, and a direct connection to our patients and our mission.  These elements unquestionably make AVEO a top place to work.”

About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA^® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences Innovation Center, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.

Contacts

Media:
John F. Kouten
JFK Communications, Inc.
jfkouten@jfkhealth.com
(609) 241-7352

Source: AVEO Pharmaceuticals, Inc.