Extended follow-up from JAVELIN Renal 101: subgroup analysis of avelumab plus axitinib versus sunitinib by the International Metastatic Renal Cell Carcinoma Database Consortium risk group in patients with advanced renal cell carcinoma
Year: 2023
Type: article
Abstract: BACKGROUND: We report updated data for avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma from the third interim analysis of the phase III JAVELIN Renal 101 trial. PATIENTS AND METHODS: Progression-free survival (PFS), objective response rate (ORR), and duration of response per investigator assessment (RECIST version 1.1) and overall survival (OS) were evaluated in the overall population and in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups; safety was also assessed. RESULTS: Overall, median OS [95% confidence interval (CI)] was not reached [42.2 months-not estimable (NE)] with avelumab plus axitinib versus 37.8 months (31.4-NE) with sunitinib [hazard ratio (HR) 0.79, 95% CI 0.643-0.969; one-sided P = 0.0116], and median PFS (95% CI) was 13.9 months (11.1-16.6 months) versus 8.5 months (8.2-9.7 months), respectively (HR 0.67, 95% CI 0.568-0.785; one-sided P < 0.0001). In patients with IMDC favorable-, intermediate-, poor-, or intermediate plus poor-risk disease, respectively, HRs (95% CI) for OS with avelumab plus axitinib versus sunitinib were 0.66 (0.356-1.223), 0.84 (0.649-1.084), 0.60 (0.399-0.912), and 0.79 (0.636-0.983), and HRs (95% CIs) for PFS were 0.71 (0.490-1.016), 0.71 (0.578-0.866), 0.45 (0.304-0.678), and 0.66 (0.550-0.787), respectively. ORRs, complete response rates, and durations of response favored avelumab plus axitinib overall and across all risk groups. In the avelumab plus axitinib arm, 81.1% had a grade ≥3 treatment-emergent adverse event (TEAE), and incidences of TEAEs and immune-related AEs were highest <6 months after randomization. CONCLUSIONS: Avelumab plus axitinib continues to show improved efficacy versus sunitinib and a tolerable safety profile overall and across IMDC risk groups. The OS trend favors avelumab plus axitinib versus sunitinib, but data remain immature; follow-up is ongoing. TRIAL REGISTRATION: ClinicalTrials.govNCT02684006; https://clinicaltrials.gov/ct2/show/NCT02684006.
Source: ESMO Open
Institutions: The Netherlands Cancer Institute, Royal Marsden NHS Foundation Trust, Royal Marsden Hospital, Dana-Farber Cancer Institute, Institut Gustave Roussy, Vanderbilt University, Vanderbilt-Ingram Cancer Center, Georgetown Lombardi Comprehensive Cancer Center, Comprehensive Cancer Center Vienna, Medical University of Vienna, Pfizer (United States), Memorial Sloan Kettering Cancer Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,290
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Merck, Sanofi, American Society of Clinical Oncology, Memorial Sloan-Kettering Cancer Center, Dana-Farber Cancer Institute, Dana-Farber/Harvard Cancer Center, Regeneron Pharmaceuticals, Merck KGaA, Exelixis, PTC Therapeutics, Les Laboratories Pierre Fabre, National Comprehensive Cancer Network, Arrowhead Pharmaceuticals, Incyte, Calithera Biosciences, Seagen, Cancer Research UK, Eisai, Astellas Pharma, Shionogi, European Society for Medical Oncology, Ipsen, EUSA Pharma, Genentech, Pharmacyclics, National Cancer Institute
OpenAlex ID: W4366979635