Observational studyCancer medicine2025
Final Analysis of Post-Marketing Surveillance for Avelumab + Axitinib in Patients With Renal Cell Carcinoma in Japan.
Observational study in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study.Scientific reports · 2025Article
- Post-marketing surveillance data for avelumab + axitinib treatment in patients with advanced renal cell carcinoma in Japan: Subgroup analyses by pathological classification.International journal of urology : official journal of the Japanese Urological Association · 2025Article
- Avelumab + axitinib treatment in older patients with advanced renal cell carcinoma in Japan: Subgroup analyses of post-marketing surveillance data by age.Cancer medicine · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
introductionAvelumab, an anti-programmed death ligand 1 antibody, was approved in combination with axitinib for curatively unresectable or metastatic renal cell carcinoma (RCC) in Japan in December 2019. Because the pivotal JAVELIN Renal 101 study included a limited number of Japanese patients, post-marketing surveillance (PMS) was required to evaluate outcomes (safety and effectiveness) in patients with RCC who received avelumab + axitinib treatment in clinical practice in Japan. MATERIALS AND
methodsWe report data from prospective, noncomparative, multicenter, observational PMS in patients with RCC who received ≥ 1 dose of avelumab. Patients were enrolled between December 2019 (date of regulatory approval) and May 2021. The primary objective was to evaluate safety, defined as adverse drug reactions (ADRs) of safety specifications occurring during an observation period of ≤ 52 weeks for each patient. The secondary objective was to evaluate effectiveness, including best overall response and overall survival (OS).
resultsIn total, 328 patients were included in the safety and effectiveness analysis sets. Overall, 173 patients (52.7%) had ADRs of safety specifications of any grade, most commonly thyroid dysfunction (n = 69 [21.0%]), infusion reaction (n = 65 [19.8%]), and hepatic disorders (n = 45 [13.7%]). Objective responses occurred in 118 patients (36.0%), including complete or partial responses in 13 (4.0%) and 105 (32.0%), respectively; the disease control rate was 75.6%. The 12-month OS rate was 83.7% (95% CI, 78.9%-87.4%). DISCUSSION: This PMS confirmed the safety, tolerability, and effectiveness of avelumab + axitinib in patients with RCC in clinical practice in Japan, with a benefit-risk profile comparable to that observed in clinical trials.
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