AVEO Oncology Rejoices FDA Approval for TKI, Finds Able Partner in BMS to Trial Combo Therapy for Kidney Cancer

On March 10th, Boston-based AVEO Oncology announced FDA approval of its renal cell carcinoma drug, FOTIVDA (tivozanib), based on the Phase 3 clinical trial TIVO-3. The drug, which suffered a number of setbacks before the eventual approval, will be made available to patients by the end of March. This approval will provide renewed hope to AVEO Oncology’s future plans.

“Today’s approval of FOTIVDA provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies. With advances in RCC treatment, patients are living longer, increasing the need for proven, well tolerated treatment options in the relapsed or refractory setting” Dr. Brian Rini, investigator of the TIVO-3 trial.

FOTIVDA

Tyrosine kinases have been at the forefront of cancer treatment as hyperactivation of these kinases leads to a cellular proliferation in cancer cells. Especially, the inhibition of tyrosine kinases such as vascular endothelial growth factor receptor (VEGFR) has helped the improvement of cancer therapy. FOTIVDA is a next-generation orally available VEGFR tyrosine kinase inhibitor.

Michael Bailey, the CEO of AVEO, added, “We believe in FOTIVDA’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory RCC, and today marks the culmination of many years of hard work and determination of many individuals to bring this therapy to patients. With today’s approval, AVEO begins its journey as a commercial-stage company, a noteworthy accomplishment in our industry. On behalf of the entire AVEO team, I would like to thank all the patients, their families, and caregivers whose tireless efforts made this day possible.”

TIVO-3 Trial

TIVO-3 is a Phase 3 double-blinded clinical trial aimed at demonstrating the safety and efficacy of FOTIVDA in patients with advanced renal cell carcinoma. A total of 350 patients were enrolled in the study, with half of them receiving the drug.

The study met its primary endpoint, which was progression-free survival (PFS). Patients treated with FOTIVDA had PFS of 5.6 months compared to 3.9 months for the control arm. Further, the drug also met one of the key secondary endpoints, which was the overall response rate (ORR). However, all the data from this trial was not positive. The overall survival (OS) reduced from 19.2 months to 16.4 months post-treatment. The most common adverse reactions fatigue, hypertension, diarrhea, decreased appetite, and nausea.

“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.” Dr. Rini added.

Path to FDA Approval and Competition

FOTIVDA received its first approval for renal cancer treatment back in 2017 in Europe based on their trial TIVO-1. However, that was not enough for the FDA as it refused approval last year. The agency had already rejected the drug back in 2013. The second rejection led to AVEO Oncology’s shares dropping by 40%, and the company ran the risk of withdrawing the drug.

This approval injects new life into FOTIVDA as their shares jumped by close to 90% after the FDA approval. This is just the beginning of the road for the drug, which will face stiff competition from Bayer’s Nexavar, Elli Lily’s Elunate, and Elevar Therapeutics’ Rivoceranib. It will be interesting to see if the stock market’s momentum will help AVEO catch up with the competition.

On March 12th, AVEO announced that it has entered into a clinical trial collaboration and supply agreement with BMS to evaluate FOTIVDA in combination with OPDIVO (nivolumab), an anti-PD-1 therapy, in the pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.

Related Article: Merck, Eisai’s Combo Therapy Registers Superiority against Pfizer’s Drug in Kidney Cancer Trial

Author

Tulip Chakraborty