A recent Phase III clinical trial, TiNivo-2, investigated the efficacy of tivozanib, a vascular endothelial growth factor receptor (VEGFR) inhibitor, as a monotherapy versus in combination with nivolumab, an immune checkpoint inhibitor (ICI), in patients with advanced renal cell carcinoma (RCC) who had previously progressed during or after one to two lines of therapy, including at least one ICI. The study's findings indicate that tivozanib monotherapy demonstrates superior progression-free survival (PFS) compared to the combination therapy in this patient population.
The TiNivo-2 trial was a multicenter, randomized study designed to evaluate the potential benefits of combining a VEGFR inhibitor with an ICI in patients who had already experienced disease progression on or after ICI treatment. The rationale behind the study was to determine if re-challenging the immune system in combination with angiogenesis inhibition could improve outcomes in this setting.
The results of the trial showed that patients receiving tivozanib monotherapy had a median PFS of 7.4 months, while those receiving the combination therapy had a median PFS of 5.7 months. The hazard ratio (HR) for PFS was 1.10 (95% CI 0.84–1.43; P = 0.49), indicating that the combination therapy did not provide a statistically significant improvement in PFS compared to tivozanib alone. These findings suggest that re-challenging patients with advanced RCC with ICI therapy after prior progression on such therapy is not advisable.
These results support the use of tivozanib monotherapy as a viable treatment option in the post-ICI setting for advanced RCC. The study underscores the importance of carefully considering treatment strategies following ICI failure and suggests that VEGFR inhibition alone may be a more effective approach than combination strategies in this context.
