– Pre-planned futility analysis of the trial expected midyear 2017; topline data expected in the first quarter of 2018 –
CAMBRIDGE, MA, USA I June 20, 2017 I AVEO Oncology (NASDAQ: AVEO) today announced that the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC) has reached its enrollment target of 322 patients, more than two months ahead of the Company’s initial guidance. Tivozanib, the Company’s lead program, is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors. A pre-planned futility analysis of the TIVO-3 trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.
“Reaching our enrollment goal for the TIVO-3 trial is a meaningful milestone for AVEO, which we believe reflects the support of many individuals within the Company, our medical partners in the oncology community and the patients we serve,” said Michael Bailey, president and chief executive officer of AVEO. “As previously noted, based on a recommendation by the Safety Monitoring Committee, the study will continue enrolling additional patients for the next few weeks to replace early dropouts. We look forward to several key upcoming potential inflection points in the tivozanib program, including a European regulatory decision and ongoing enrollment in the TiNivo study, culminating in the readout of the TIVO-3 trial, expected in the first quarter of 2018.”
The TIVO-3 trial is enrolling patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability.
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.
SOURCE: AVEO Oncology
Post Views: 248
– Pre-planned futility analysis of the trial expected midyear 2017; topline data expected in the first quarter of 2018 –
CAMBRIDGE, MA, USA I June 20, 2017 I AVEO Oncology (NASDAQ: AVEO) today announced that the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC) has reached its enrollment target of 322 patients, more than two months ahead of the Company’s initial guidance. Tivozanib, the Company’s lead program, is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors. A pre-planned futility analysis of the TIVO-3 trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.
“Reaching our enrollment goal for the TIVO-3 trial is a meaningful milestone for AVEO, which we believe reflects the support of many individuals within the Company, our medical partners in the oncology community and the patients we serve,” said Michael Bailey, president and chief executive officer of AVEO. “As previously noted, based on a recommendation by the Safety Monitoring Committee, the study will continue enrolling additional patients for the next few weeks to replace early dropouts. We look forward to several key upcoming potential inflection points in the tivozanib program, including a European regulatory decision and ongoing enrollment in the TiNivo study, culminating in the readout of the TIVO-3 trial, expected in the first quarter of 2018.”
The TIVO-3 trial is enrolling patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability.
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.
SOURCE: AVEO Oncology
Post Views: 248
