Journal Article

Bayesian Evaluation of Treatment Effect of Avelumab Plus Axitinib for Advanced Renal Cell Carcinoma

Imai, Yu, Kimura, Takahiro, Mori, Keiichiro, Hirakawa, Akihiro, Ito, Kagenori, Fukuokaya, Wataru, Urabe, Fumihiko, Shariat, Shahrokh F., Yanagisawa, Takafumi, Rajwa, Pawel

2026

Overview

Background Despite not achieving statistical significance, the JAVELIN Renal 101 trial indicated a potentially clinically relevant effect size (hazard ratio [HR], 0.88; 95% confidence interval, 0.75 to 1.04) on overall survival (OS) favoring avelumab plus axitinib over sunitinib for advanced renal cell carcinoma (aRCC). To better interpret these findings, we performed a Bayesian evaluation. Methods We reanalyzed individual participant data from the JAVELIN Renal 101 trial using a Bayesian framework. Prior distributions were specified for varying levels of enthusiasm and skepticism for avelumab plus axitinib, and a prior from a meta‐analysis of similar trials. The posterior probability of any OS benefit with avelumab plus axitinib, Pr(HR < 1.0), and of benefit exceeding the minimal clinically important difference (MCID; HR = 0.75), Pr(HR < MCID), were estimated using Bayesian Cox models. Bayesian hierarchical models evaluated treatment effect heterogeneity across International Metastatic Renal Cell Carcinoma Database Consortium risk groups and programmed death‐ligand 1 (PD‐L1) status. Results Regardless of the prior assumptions used, Pr(HR < 1.0) was consistently high (93.0% to 95.5%). However, Pr(HR < MCID) was low (1.0% to 3.8%). Results were similar when the prior was informed by pooled data from similar trials. In subgroup analyses, Pr(HR < MCID) varied by risk group: 63.4% for poor‐risk, 34.9% for favorable‐risk, and 0.9% for intermediate‐risk aRCC. This probability was low regardless of PD‐L1 status. Conclusions This exploratory Bayesian reanalysis complements the interpretation of the JAVELIN Renal 101 trial and offers a probabilistic perspective beyond a dichotomous (i.e., significant/nonsignificant) interpretation.

• Publisher: John Wiley & Sons, Inc,Wiley
• Subject: Antibodies, Monoclonal, Humanized - administration & dosage / Antibodies, Monoclonal, Humanized - therapeutic use / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Apoptosis / Axitinib - administration & dosage / Axitinib - therapeutic use / Bayes Theorem / Bayesian analysis / Carcinoma, Renal Cell - drug therapy / Carcinoma, Renal Cell - mortality / Carcinoma, Renal Cell - pathology / Combination therapy / Estimates / Female / Humans / immune checkpoint inhibitor / Kidney cancer / Kidney Neoplasms - drug therapy / Kidney Neoplasms - mortality / Kidney Neoplasms - pathology / Male / Mathematical models / Medical prognosis / Metastases / Oncology / overall survival / PD-L1 protein / Pessimism / Probability / Probability distribution / Renal cell carcinoma / Risk groups / Treatment Outcome / Tumors / Vascular endothelial growth factor