Aveo Oncology Received FDA Approval for FOTIVDA for Advanced RCC
Aveo Oncology (AVEO) drug FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) 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 plans to make FOTIVDA available to patients in the U.S. by March 31, 2021.
- The approval of FOTIVDA is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.
- Patients enrolled in the TIVO-3 study were randomized 1:1 to receive either FOTIVDA or sorafenib. The main efficacy outcome measure was progression-free survival (PFS), assessed by a blinded independent radiology review committee. Other efficacy endpoints were overall survival (OS) and objective response rate (ORR).
- Median PFS was 5.6 months in the FOTIVDA arm compared with 3.9 months for those treated with sorafenib.
- Median OS was 16.4 and 19.2 months, for the FOTIVDA and sorafenib arms, respectively.
- ORR was 18% for the FOTIVDA arm and 8% for the sorafenib arm.
- The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.
- The most common grade 3 or 4 laboratory abnormalities (≥5%) were decreased sodium, increased lipase, and decreased phosphate.
From the Vanderbilt Ingram Cancer Center
Brian Rini, MD, Chief of Clinical Trials at Vanderbilt Ingram Cancer Center and principal investigator of the TIVO-3 trial stated, "FOTIVDA's approval provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies." Dr. Rini continued, “With advances in RCC treatment, patients are living longer, increasing the need for proven, well-tolerated treatment options in the relapsed or refractory setting. The TIVO-3 study is the first positive Phase 3 study in RCC patients who received two or more prior systemic therapies, and also the first Phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment. With this approval, I believe FOTIVDA represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape.”Prohost Observations
After soaring yesterday on the approval news, the stock is trading at $12.86, losing more than 15% to profit-taking. We will have to keep our eyes on this stock for a while before we can fairly evaluate its worth.Visit our website for other news.
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