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Alexander Chehrazi-Raffle, MD, discusses findings from an exploratory analysis of the TiNivo-2 trial of tivozanib with/without nivolumab in metastatic RCC.
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“In patients who had received prior nivolumab and ipilimumab it wasn’t too surprising that we categorically saw more robust responses [among] those who then went on to receive tivozanib monotherapy.”
Alexander Chehrazi-Raffle, MD, an assistant professor in the Department of Medical Oncology & Therapeutics Research at the City of Hope, discussed findings from an exploratory analysis of the phase 3 TiNivo-2 study (NCT04987203) presented during the 2025 ASCO Annual Meeting.
In the analysis, patients with metastatic renal cell carcinoma (RCC) received either single-agent tivozanib (Fotivda) or tivozanib in combination with nivolumab (Opdivo) following treatment with nivolumab and ipilimumab (Yervoy) or a VEGF TKI. Patients who received frontline ipilimumab plus nivolumab who then received tivozanib monotherapy (n = 37) achieved a median progression-free survival (PFS) of 9.2 months (95% CI, 4.5-not reached). Those who received first-line nivolumab and ipilimumab who went on to receive tivozanib plus nivolumab (n = 33) experienced a median PFS of 9.3 months (95% CI, 7.5-15.3).
The respective overall response rates (ORRs) were 35.1% (95% CI, 18.0%-49.8%) and 24.2% (95% CI, 11.1%-42.3%) among patients who went on to receive the second-line monotherapy or combination. There were no complete responses (CRs) in either subgroup.
Chehrazi-Raffle noted that it was not surprising that patients who had received prior nivolumab and ipilimumab achieved more robust responses with tivozanib monotherapy. These patients had never received a VEGF TKI–containing combination previously, he noted. Tivozanib monotherapy was given at a dose of 1.34 mg daily, which was higher than the 0.89-mg dose of tivozanib used in addition to nivolumab in the second-line combination, he added. These patients also performed better than those who received a VEGF TKI plus an immune checkpoint inhibitor (ICI) in the first-line setting, he concluded.
Patients who received a frontline TKI in combination with an ICI who then received tivozanib monotherapy (n = 41) achieved a median PFS of 7.4 months (95% CI, 3.7-9.3) and an ORR of 22.0% (95% CI, 10.6%-37.6%). Patients in this subgroup who went on to receive second-line tivozanib plus nivolumab (n = 42) achieved a median PFS of 3.9 months (95% CI, 2.1-5.7) and an ORR of 9.5% (95% CI, 2.7%-22.6%).
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