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TiNivo-2 Trial Does Not Meet Progression-Free Survival For Patients With Renal Cell Carcinoma
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There were positive efficacy and safety results for tivozanib monotherapy consistent with previous analyses.
The TiNivo-2 phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma (RCC) whose tumors progressed after prior immune checkpoint inhibitor (ICI) treatment did not meet the primary endpoint of increasing progression free survival (PFS) when nivolumab (Opdivo; Bristol Myers Squibb) was added to low-dose tivozanib (Fotivda; AVEO Oncology), according to a news release from AVEO.1
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These results indicate that the drug combination was not superior to standard dose tivozanib alone, but the tivozanib monotherapy arm of the study provided clinically meaningful efficacy data for the drug.1
“The PFS and safety of the FOTIVDA control arm in the second-line following ICI combinations adds to the growing body of evidence of the importance of a highly selective anti-VEGFR TKI therapy as an effective, well-tolerated treatment option for relapsed or refractory RCC patients treated with prior ICI combination therapy,” Michael P. Bailey, CEO and president of AVEO Oncology, said in a news release.1
He continued, saying that although the addition of nivolumab to low-dose tivozanib did not improve PFS outcomes after prior ICI, AVEO considers the control arm of the study “an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations.”1
In 2021, tivozanib was approved by the FDA as the first therapy for adult patients with relapsed or refractory (R/R) RCC following 2 or more prior systemic therapies. That approval was based on the TIVO-3 clinical trial, which indicated strong PFS and efficacy endpoints for tivozanib compared to sorafenib (Nexavar; Bayer HealthCare Pharmaceuticals Inc).2
In that trial, the median PFS was 5.6 months in the tivozanib arm compared to 3.9 months in the sorafenib arm. Additionally, the median overall survival (OS) was 16.4 and 19.2 months for the tivozanib and sorafenib groups, respectively.2
Post-hoc analysis from the trial that was released in May 2024, the investigators found that tivozanib had a consistent safety profile and long-term survival for R/R RCC in patients who were alive and progression-free at 12 months. Their results also reinforced the finding that tivozanib had clinically meaningful improvements in OS compared to sorafenib.3
According to AVEO, the results from TiNivo-2 are consistent with other RCC phase 3 trials that featured a similar patient population. This is the second phase 3 trial with results that indicate there is no clinical benefit associated with rechallenging RCC patients with immunotherapy following ICI treatment.1
“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, a lead investigator on the TiNivo-2 study, said in the news release.1
The trial’s primary outcome was PFS, and secondary endpoints included OS, overall response rate, the duration of the response, and safety of the drug in patients. Patients were enrolled in clinical sites across North and Latin America and Europe.1
The detailed findings of the trial are expected to be presented at an upcoming medical meeting, according to the news release.
