Evidence map›Paper›PMID 41164966›Full record

ArticleCancer medicine2025

Real-World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance.

Eiji Kikuchi, Masayoshi Nagata, Taito Ito, Masashi Sato, Mie Ogi, Makiko Morita, Masahiro Kajita, Hiroyuki Nishiyama

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Observational
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Eiji KikuchiDepartment of Urology, St. Marianna University School of Medicine, Kanagawa, Japan.ORCID https://orcid.org/0000-0002-1624-6676
Masayoshi NagataDepartment of Urology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Taito ItoMedical Department, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany.
Masashi SatoResearch and Development, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany.
Mie OgiGlobal Development Operations, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany.
Makiko MoritaGlobal Patient Safety Japan, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany.
Masahiro KajitaMedical Department, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany.
Hiroyuki NishiyamaDepartment of Urology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.

Funding

Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945)Pfizer
6 · The paper itself

Abstract

backgroundAvelumab maintenance therapy was approved in Japan in February 2021 for the treatment of curatively unresectable urothelial carcinoma (UC) that has not progressed after prior chemotherapy based on results from the JAVELIN Bladder 100 phase 3 trial. We report the final analysis of postmarketing surveillance (PMS) data on the safety and effectiveness of avelumab maintenance in clinical practice in Japan.

methodsThis prospective, multicenter, noninterventional PMS evaluated patients with curatively unresectable UC who received ≥ 1 dose of avelumab maintenance in Japan between February 2021 and December 2021. The observation period was ≤ 52 weeks in all patients. The primary objective was to evaluate the safety of avelumab maintenance based on the occurrence of prespecified adverse drug reactions (ADRs). The secondary objective was to evaluate effectiveness, including time to treatment failure (TTF), time to next-line treatment (TTNT), and overall survival (OS).

resultsData were collected from 453 patients at 213 sites (data cutoff: March 6, 2024). Median age was 73 years, 90.3% had metastatic disease, and prior chemotherapy regimen was gemcitabine + cisplatin in 267 (58.9%), gemcitabine + carboplatin in 163 (36.0%), and others in 23 (5.1%). Any-grade prespecified ADRs occurred in 144 patients (31.8%), including grade ≥ 3 in 35 patients (7.7%). The most common any-grade prespecified ADRs were infusion reaction (11.7%) and thyroid dysfunction (7.3%). Median TTF was 4.6 months (95% CI, 3.8-5.3 months). Median TTNT was 9.9 months (95% CI, 8.3 months-not estimable). OS rates at 6 and 12 months were 89.2% (95% CI, 86.0%-91.8%) and 77.9% (95% CI, 73.7%-81.5%), respectively.

conclusionFinal analysis of PMS provides the largest real-world dataset of avelumab maintenance in Japan reported to date. Findings demonstrate the acceptable safety, tolerability, and effectiveness of avelumab maintenance, consistent with data from JAVELIN Bladder 100 and real-world studies in other countries, and support its continued use in clinical practice.

trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN 43435.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellUrinary Bladder NeoplasmsAgedAged, 80 and overFemaleHumansJapanMaintenance ChemotherapyMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalavelumabavelumabeffectivenessmaintenancepostmarketing surveillancesafetyurothelial carcinoma

Identifiers

PMID41164966
PMCPMC12572945

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.