Fotivda Monotherapy Demonstrated Efficacy in Previously Treated Metastatic RCC

A subgroup analysis of the phase 3 TiNivo-2 trial alluded to the potential, yet comparable, benefit of Fotivda (tivozanib) alone or in combination with Opdivo (nivolumab) in patients with metastatic renal cell carcinoma (RCC) who had progressed on first-line immune checkpoint inhibitor (ICI)-based regimens.

According to Dr. Alexander Chehrazi-Raffle, the Fotivda monotherapy demonstrated comparable or superior progression-free survival and objective response rates versus the combination therapy in both cohorts. The median progression-free survival was 9.2 months with Fotivda and 9.3 months with Fotivda plus Opdivo. Moreover, the overall response rates were 32.4% and 24.2%, respectively. In the TKI/ICI cohort, progression-free survival and overall response rate were longer and higher with Fotivda monotherapy.

To further expand on the topic, Chehrazi-Raffle sat down for an interview with CURE, live from the 2025 ASCO Annual Meeting, where he discussed how this study may help clarify whether Fotivda alone or combined with Opdivo is a better second-line treatment option for patients whose mRCC has progressed after initial immunotherapy. Additionally, he touched on if the effectiveness of second-line Fotivda therapy may vary depending on the specific treatments patients previously received.

Chehrazi-Raffle is an assistant professor in the Department of Medical Oncology & Therapeutics Research, at City of Hope, located in Duarte, California.

Transcript:

Yeah, I think the subgroup analysis reiterates what we found in the phase 3 trial: the combination of immunotherapy plus VEGF is not superior to VEGF alone after patients have already progressed on an immunotherapy regimen. What it did elucidate, though, is that Fotivda can be considered as monotherapy at the 1.34 milligram dose in the second-line setting.

We saw more immune-related toxicity, not surprisingly, in the patients who received Opdivo. But as far as whether or not the expected side effects related to VEGF TKIs were higher in the Fotivda monotherapy arm versus the combination arm, the answer would be not really noticeably.

Transcript has been edited for clarity and conciseness.

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