The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death in kidney cancer patients who had tried an immune checkpoint inhibitor (ICI).
Despite the failure of the phase 3 trial on its primary endpoint of progression-free survival (PFS) for the combo, Aveo is touting the results from the control arm where a standard dose of Fotivda as a monotherapy showed a clinically meaningful outcome in median PFS.
Approved in Europe in 2017 and in the United States in 2021 for third-line treatment of kidney cancer, Fotivda showed its ability to excel in an earlier line of therapy, according to the trial’s lead investigator.
“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,” Toni Choueiri, M.D., a professor of medicine at Harvard Medical School said in a release.
In the TiNivo-2 phase 3 trial, a 0.89 mg dose of Fotivda was combined with Opdivo. In the control arm, a standard 1.34 mg dose of Fotivda was used. Aveo did not reveal data from the study, saying it would provide more details at an upcoming medical meeting.
The results build on the TIVO-3 clinical trial, which evaluated Fotivda in the third-line setting against Bayer’s Nexavar and set up the VEGFR tyrosine kinase inhibitor for its approvals.
“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,” Michael Bailey, Aveo’s CEO, said.
It is the second phase 3 trial to show that there is no clinical benefit from “rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs,” Aveo added.
In October 2022, Aveo was acquired by another Korean company, LG Chem, which paid a 43% premium of $566 million for the buyout to gain Fotivda and Aveo’s portfolio of other cancer candidates.
On its way to gaining approval of Fotivda nine years after its original submission to the FDA, Aveo had to clear multiple hurdles including investor lawsuits, failed trials, an SEC investigation and two rejections from the U.S. regulator.