Avelumab Plus Axitinib Demonstrates Long-Term Efficacy, Safety for Patients With Advanced Renal Cell Carcinoma
Final Results From the Phase 3 JAVELIN Renal 101 Trial
Final Results From the Phase 3 JAVELIN Renal 101 Trial
According to final results from the phase 3 JAVELIN Renal 101 trial, avelumab plus axitinib demonstrated long-term efficacy and safety among patients with previously untreated advanced renal cell carcinoma (aRCC).
“Avelumab + axitinib is an approved first-line treatment for patients with advanced renal cell carcinoma in multiple countries, and a recommended option in guidelines,” stated Toni Choueiri, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, and coauthors. While OS data were immature at the time of prior analysis from JAVELIN Renal 101, it is reported here in the final analysis.
In this study, 886 previously untreated patients with advanced renal cell carcinoma were randomized to receive either avelumab plus axitinib (n = 442) or sunitinib (n = 444) until disease progression or unacceptable toxicity. The primary end point was OS among patients with PD-L1 positive tumors (n = 560). Key secondary end points included event-free survival rate, objective response rate (ORR), duration of response, and safety in the overall population.
At a median follow-up of 68 months, median OS was 42.3 months in the avelumab plus axitinib arm and 36.2 months in the sunitinib arm (hazard ratio [HR], 0.86; confidence interval [CI] 0.701 to 1.057; P = .0755) among patients with PD-L1 positive tumors. In the overall population, median OS was 44.8 months and 38.9 months, respectively (HR, 0.88; CI 0.749 to 1.039; P = .0669). The 5-year event-free survival rate was 12% in the avelumab plus axitinib arm and 4.4% in the sunitinib arm and the ORR was 59.7% and 32%, respectively. Duration of response was ≥ 5 years in 16.4% of patients in the avelumab plus axitinib arm and 9.2% in the sunitinib arm. Grade ≥3 treatment-related adverse events occurred in 66.8% of patients in the avelumab plus axitinib arm and 61.5% of patients in the sunitinib arm.
“JAVELIN Renal 101 provides the longest follow-up of any phase 3 trial evaluating immune checkpoint inhibitor (ICI) + tyrosine kinase inhibitor (TKI) combination treatment in patients with aRCC,” concluded Dr Choueiri et al. Results “showed long-term efficacy benefits, a manageable safety profile, and stable quality of life with first-line avelumab + axitinib in patients with aRCC.”
Source:
Choueiri TK, Penkov K, Uemura H, et al. Avelumab + axitinib vs sunitinib as first-line treatment for patients with advanced renal cell carcinoma: Final analysis of the phase 3 JAVELIN Renal 101 trial. Ann Oncol. Published online: December 17, 2024. doi: 10.1016/j.annonc.2024.12.008
