Abstract 279P
Background
Avelumab maintenance therapy was approved worldwide based on results from the JAVELIN Bladder 100 phase III trial, which demonstrated significantly prolonged overall survival (OS) in patients (pts) with advanced urothelial carcinoma (UC) without disease progression after first-line platinum-based chemotherapy. Analyses from postmarketing surveillance (PMS) data demonstrated the safety and effectiveness of avelumab maintenance therapy in clinical practice in Japan. Here we report post hoc analyses of data from PMS in subgroups defined by age.
Methods
This PMS is a multicenter, observational surveillance of pts with UC who received ≥1 dose of avelumab between Feb 24, 2021, and Dec 7, 2021. The observation period was ≤52 weeks. Safety and effectiveness were analyzed in the overall population and in patients aged ≤64, 65-74, and ≥75 years.
Results
The analysis set included 453 pts, of whom 75 (16.6%) were aged ≤64 years, 198 (43.7%) were aged 65-74 years, and 180 (39.7%) were aged ≥75 years. At data cutoff (Mar 6, 2024), median duration of therapy was 22.0 weeks (range, 2-52 weeks); 128 pts (28.3%) remained on avelumab maintenance, and 184 (40.6%) received subsequent treatment. Adverse drug reactions of safety specifications of any grade occurred in 144 pts (31.8%) in the overall population, 17 (22.7%) aged ≤64 years, 69 (34.9%) aged 65-74 years, and 58 (32.2%) aged ≥75 years, with grade ≥3 in 36 (7.9%), 2 (2.7%), 15 (7.8%), and 18 (10.0%), respectively. Median OS was not reached in the overall population, and the 1-year OS rate (95% CI) was 77.9% (73.7%-81.5%) in the overall population, 77.6% (66.1%-85.6%) in pts aged ≤64 years, 82.7% (76.6%-87.3%) in pts aged 65-74 years, and 72.6% (65.3%-78.6%) in pts aged ≥75 years.
Conclusions
This PMS is the largest real-world data set of avelumab maintenance therapy in Asia. Post hoc analyses of PMS demonstrated the safety and effectiveness of avelumab maintenance in clinical practice in Japan, with a favorable benefit:risk profile observed across all age groups. Our findings are comparable to findings from JAVELIN Bladder 100 and real-world studies from other countries.
Clinical trial identification
Editorial acknowledgement
Medical writing support was provided by Katherine Quiroz-Figueroa of Nucleus Global.
Legal entity responsible for the study
Merck Biopharma Co., Ltd., Tokyo, Japan (CrossRef Funder ID: 10.13039/100009945).
Funding
This work was supported by Merck Biopharma Co., Ltd., Tokyo, Japan (CrossRef Funder ID: 10.13039/100009945) and was previously conducted under an alliance between Merck and Pfizer.
Disclosure
M. Nagata: Financial Interests, Personal, Speaker’s Bureau: Janssen, Sanofi. E. Kikuchi: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca, Bristol Myers Squibb-Ono Pharmaceutical, Chugai Pharmaceutical, Janssen, Merck, MSD, Pfizer; Financial Interests, Personal, Speaker’s Bureau: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb-Ono Pharmaceutical, Chugai Pharmaceutical, Janssen, Kissei Pharmaceutical, Kyorin, Kyowa Kirin International, Merck, MSD, Nippon Kayaku, Nippon Shinyaku, Pfizer, Sanofi, Taiho Pharmaceutical, Takeda; Financial Interests, Institutional, Research Funding: Chugai Pharmaceutical, Kissei Pharmaceutical, Kyorin, Kyowa Kirin International, Nippon Kayaku, Nippon Shinyaku, Otsuka, Sanofi, Taiho Pharmaceutical, Takeda. T. Ito, M. Sato, M. Morita, M. Kajita: Financial Interests, Personal, Full or part-time Employment: Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA. H. Nishiyama: Financial Interests, Personal, Speaker’s Bureau: Astellas Pharma, Merck, MSD, Olympus; Financial Interests, Personal, Research Funding: Chugai Pharmaceutical , Ono Pharmaceutical.