Final Analysis of JAVELIN Renal 101 Shows Long-Term Efficacy of Avelumab Plus Axitinib

Robert Motzer, MD, presented data from the final overall survival (OS) analysis of the phase 3 JAVELIN Renal 101 trial at the 2024 American Society of Clinical Oncology Annual Meeting.

The trial analyzed the efficacy of first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma (aRCC). A total of 886 patients were randomized to receive either avelumab plus axitinib or sunitinib. Independent primary end points included OS and progression-free survival (PFS) in patients with PD-L1–positive tumors, while secondary end points included OS and PFS in the overall population.

The trial previously met one of its primary end points by demonstrating significantly longer PFS rates with avelumab plus axitinib over sunitinib in patients with PD-L1–positive tumors. In the overall population, longer PFS, higher objective response rate, and an acceptable safety profile were also observed. At the time, OS data were still immature.

Of 886 patients randomized, 560 (63.2%) had PD-L1–positive tumors. At the time of data cutoff in August 2023, the median follow-up in the avelumab plus axitinib and sunitinib arms was 73.7 and 73.6 months, respectively (≥68 months in all patients).

In the PD-L1–positive population, the median OS of the avelumab plus axitinib group (n=270) was 43.2 (36.5-51.7), and it was 36.2 (29.8-44.2) in the sunitinib group (n=290); in the overall population, the OS rate for each group was 44.8 (n=442; 39.7-51.1) and 38.9 (n=444; 31.4-45.2), respectively.

In the avelumab plus axitinib and sunitinib arms, grade ≥3 treatment-related adverse events occurred in 66.8% and 61.5% of patients, respectively. Second-line therapy was received by 58.1% and 69.4% of patients, including a PD-L1 inhibitor in 18.8% and 53.6% patients, respectively.

JAVELIN Renal 101 provided the longest phase 3 trial follow-up for an immune checkpoint inhibitor in combination with a tyrosine kinase inhibitor to date. Avelumab plus axitinib was favored over sunitinib by OS analysis, but it did not reach statistical significance.

PFS rates were longer with avelumab plus axitinib versus sunitinib, and durable responses were seen in a subset of patients. These final analysis results confirm the long-term efficacy and manageable safety profile of avelumab plus axitinib in patients with aRCC.