Aveo finds silver lining in failed Fotivda kidney cancer trial

Aveo Oncology's phase 3 trial of Fotivda combined with Bristol Myers Squibb's Opdivo in kidney cancer patients has not met its primary goal. Although the combination did not extend the time before tumor progression or death in patients who had previously tried an immune checkpoint inhibitor (ICI), the trial revealed some promising aspects.

The phase 3 trial was designed to evaluate the effectiveness of combining a 0.89 mg dose of Fotivda with Opdivo. However, the primary endpoint of progression-free survival (PFS) was not achieved. Despite this, Aveo highlighted positive results from the control arm, where a standard 1.34 mg dose of Fotivda as a monotherapy showed a clinically meaningful improvement in median PFS.

Fotivda, a drug approved in Europe in 2017 and in the United States in 2021 for third-line treatment of kidney cancer, demonstrated its potential in earlier lines of therapy. The trial's lead investigator, Toni Choueiri, M.D., a professor at Harvard Medical School, commented that the control arm results support Fotivda as an effective and well-tolerated treatment option for second-line therapy following prior ICI combinations.

In the TiNivo-2 phase 3 trial, the control arm data is considered significant by Aveo, despite the combination therapy falling short. Michael Bailey, CEO of Aveo, stated that the data from the control arm is an evidence-based and clinically meaningful contribution to the treatment of relapsed or refractory advanced renal cell carcinoma (RCC) following initial ICI combinations.

This is the second phase 3 trial to indicate that re-administering immunotherapy to RCC patients who have previously progressed on ICIs does not provide clinical benefits. Aveo emphasized that the trial’s findings add to the understanding of effective treatment options for RCC patients.

Aveo's journey with Fotivda has been marked by numerous challenges. The company was acquired by LG Chem in October 2022, a deal valued at $566 million with a 43% premium. This acquisition was aimed at leveraging Fotivda and Aveo's portfolio of other cancer drug candidates.

Fotivda’s path to approval was complex, involving nine years of effort from its original submission to the FDA. Aveo faced multiple obstacles, including investor lawsuits, failed trials, an SEC investigation, and two rejections from the U.S. regulator. Despite these hurdles, Fotivda ultimately received approval, demonstrating its potential in treating kidney cancer.

The recent trial outcomes underscore the complexities and challenges in developing effective cancer therapies. While the combination of Fotivda and Opdivo did not yield the desired PFS outcomes, the control arm results provide valuable insights that could inform future treatment strategies for advanced RCC.

Aveo remains committed to advancing cancer treatments and believes the findings from the control arm of the trial will support ongoing efforts to improve therapeutic options for patients with kidney cancer. Further details from the TiNivo-2 phase 3 trial are expected to be shared at an upcoming medical meeting, offering additional insights into the study's implications for cancer therapy.