The combination of nivolumab and tivozanib did not show an improvement in progression-free survival (PFS) for patients with advanced metastatic renal cell carcinoma (RCC) after prior treatment with immune checkpoint inhibitors, according to the results of the phase 3 TiNivo-2 trial. The trial compared the addition of nivolumab to tivozanib at a low dose with tivozanib monotherapy at a standard dose.
Although the combination therapy did not meet the primary endpoint of improved PFS, the tivozanib monotherapy arm did show clinically meaningful median PFS in the second-line setting following immune checkpoint inhibitor combination therapy. These findings build on the results of the TIVO-3 trial, which supported the FDA approval of tivozanib for the treatment of relapsed/refractory advanced RCC.
The TiNivo-2 trial is the second study to demonstrate that there is limited clinical benefit from immunotherapy rechallenge in RCC patients who have previously progressed on immune checkpoint inhibitors. Previous data from the CONTACT-03 trial also showed no improvement in PFS or overall survival with the combination of atezolizumab and cabozantinib compared to cabozantinib alone in advanced RCC patients who had received prior immune checkpoint inhibitor treatment.
Dr. Toni Choueiri, the lead investigator of the TiNivo-2 trial, emphasized that tivozanib remains an effective and well-tolerated treatment option in the second-line setting for patients who have previously received immune checkpoint inhibitor therapy. The results of the trial contribute to the growing evidence supporting the use of selective anti-VEGFR TKI therapy in patients with relapsed or refractory RCC.
While the addition of nivolumab to tivozanib did not improve PFS outcomes in this trial, the data from the control arm provide valuable information for clinicians treating patients with relapsed or refractory advanced RCC following frontline immune checkpoint inhibitor combinations. The results support the use of tivozanib as a viable treatment option in this patient population.
The randomized TiNivo-2 trial enrolled patients from various regions and investigated the efficacy of nivolumab plus tivozanib compared to tivozanib alone in the second or third-line setting after treatment with immune checkpoint inhibitors. Eligible patients had specific criteria related to disease progression, prior treatments, and performance status, among others.
In addition to PFS, the trial also evaluated secondary endpoints such as overall survival, duration of response, overall response rate, and safety. Detailed data from the TiNivo-2 trial are expected to be presented at an upcoming medical meeting, providing further insights into the use of combination therapy in advanced RCC patients.
Overall, the results of the TiNivo-2 trial highlight the importance of continued research and clinical trials to identify effective treatment strategies for patients with advanced RCC, especially those who have progressed on prior therapies. The findings contribute to the existing knowledge base and help guide treatment decisions for clinicians managing this patient population.