TiNivo-2 Trial Highlights Challenges in ICI Retreatment for Advanced RCC
Data from the phase 3 TiNivo-2 trial (NCT04987203) presented at the 2024 ESMO Congress indicates that rechallenging with immune checkpoint inhibitors (ICI) in patients with advanced renal cell carcinoma (RCC) who have progressed on or after a prior ICI-containing regimen may not be beneficial. The study compared the efficacy of tivozanib (Fotivda) plus nivolumab (Opdivo) against tivozanib monotherapy, finding no statistically significant difference in progression-free survival (PFS) between the two arms.
- Median PFS was 5.7 months in the combination arm versus 7.4 months in the monotherapy arm.
- The trial enrolled 343 patients, randomly assigned to either the combination or monotherapy arm.
Toni Choueiri, MD, highlighted that the trial was designed to explore the feasibility of ICI rechallenge in metastatic RCC, incorporating tivozanib in both arms and adding nivolumab in the experimental arm. This approach follows the CONTACT-03 trial findings, which also did not show improved outcomes with ICI rechallenge.
Key findings from TiNivo-2 include:
- No significant difference in PFS, overall survival, or objective response rates between the two treatment arms.
- Safety profiles were similar, with the combination arm experiencing a higher rate of pruritus due to nivolumab.
This study adds to the growing evidence suggesting that ICI rechallenge in metastatic RCC should be approached with caution, except in specific scenarios such as a long duration since the last ICI treatment. However, such patients were not included in the TiNivo-2 trial.
Reference: Choueiri TK, Motzer RJ, Beckermann K, et al. Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): results of the phase III TiNivo-2 study. Ann Oncol. 2024;35(suppl 1): S1261-S1262. doi:10.1016/j.annonc.2024.08.2316