Abstract 1757P
Background
In the JAVELIN Bladder 100 trial, patients with la/mUC that had not progressed after 1L platinum-based chemotherapy (CTx) had significantly prolonged overall survival (OS) with avelumab 1L maintenance + best supportive care (BSC) vs BSC only. In the AVENANCE study (NCT04822350), we investigated efficacy and safety in patients with la/muC treated with avelumab 1L maintenance in France.
Methods
In this ongoing study, eligible pts have la/mUC that did not progress after 1L platinum-based CTx and previous, ongoing, or planned avelumab maintenance. The primary endpoint is OS; secondary endpoints include progression-free survival (PFS), duration of treatment (DOT), and safety. Pts who started avelumab ≥6 months prior to data cutoff (January 31, 2022) were analyzed.
Results
The analysis included 267 pts (of 500 planned). Median follow-up was 11.4 months (range, 0-25.0). Median age was 73.1 years (Q1-Q3, 66.7-77.9). At start of 1L CTx (excluding pts with missing data), disease stage was metastatic in 237 pts (90.5%; visceral in 193 [81.8%]) and locally advanced in 25 (9.5%). ECOG performance status was 0-1 in 177 (85.5%) and 2-3 in 30 (14.5%). 1L CTx was gemcitabine + carboplatin in 152 (58.0%), gemcitabine + cisplatin in 82 (31.3%), and other CTx in 28 (10.7%). Median number of cycles was 5 (range, 1-10). Response to 1L CTx was complete response in 56 pts (21.6%), partial response in 144 (55.6%), and stable disease in 52 (20.1%). Median DOT with avelumab was 5.6 months (95% CI, 4.9-7.5). At data cutoff, 100 pts (37.5%) remained on treatment. The 12-month OS rate was 64.1% (95% CI, 57.1%-70.3%) and median PFS from start of avelumab was 5.7 months (95% CI, 5.1-7.9). Treatment-emergent adverse events (AEs) occurred in 142 pts (53.2%) with serious AEs in 58 (21.7%); 59 pts (22.1%) had an AE leading to treatment discontinuation.
Conclusions
These first real-world data for avelumab 1L maintenance in pts with la/mUC from AVENANCE support the findings of the JAVELIN Bladder 100 trial, and confirm the clinical activity and safety of avelumab in a heterogenous population.
Clinical trial identification
NCT04822350.
Editorial acknowledgement
Editorial support was provided by Abhijith Thippeswamy of ClinicalThinking, and was funded by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
Legal entity responsible for the study
This study was sponsored by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
Funding
This study was sponsored by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
Disclosure
P. Barthelemy: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Pfizer, Ipsen, Bayer, Janssen Cilag, Astellas, Novartis, Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen. C. Thibault: Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi; Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, BMS, Pfizer, Merck, Ipsen; Financial Interests, Personal, Speaker’s Bureau: Sanofi, AstraZeneca, Janssen, Astellas, MSD, BMS, IPSEN. J. Eymard: Financial Interests, Personal and Institutional, Research Grant: Pfizer, Ipsen, BMS; Financial Interests, Personal, Advisory Role: Astellas, Sanofi, Janssen, Ipsen. A. Ravaud: Financial Interests, Institutional, Research Grant: Pfizer, Merck, Ipsen; Financial Interests, Personal, Advisory Role: Pfizer, Merck, Ipsen, BMS, AstraZeneca, Eisai; Financial Interests, Personal, Other, Travelling et housing for meetings: Pfizer, Merck, Ipsen, BMS, AstraZeneca, Eisai. A. Flechon: Financial Interests, Personal, Other, Transportation: Merck, Pfizer, MSD, Gilead, Janssen. D. Pouessel: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Merck, MSD, Astellas; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Pfizer, MSD, BMS, Astellas, Janssen, Ipsen; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Pfizer, Merck. E. Nicolas: Financial Interests, Institutional, Advisory Role: Merck. G. Denechere: Financial Interests, Personal, Full or part-time Employment: Pfizer. M. Solbes: Financial Interests, Personal, Full or part-time Employment: Merck Santé SAS, Lyon, France, an affiliate of Merck KGaA. P. Lambert: Financial Interests, Personal, Full or part-time Employment: Pfizer. Y. Loriot: Financial Interests, Personal, Advisory Board: Merck Kga, Pfizer, Gilead, Seattle Genetics, Tahio; Financial Interests, Personal, Other, lectures, Advisory Boards: MSD, AstraZeneca, Astellas, Janssen; Financial Interests, Personal, Other, Lectures, Advisory Boards: Roche, BMS; Financial Interests, Institutional, Research Grant: Janssen, Sanofi, MSD, Roche, Celsius; Financial Interests, Institutional, Invited Speaker: Janssen, Pfizer, Janssen, MSD, Janssen, Exelexis, AstraZeneca, Pfizer, Merck Kga, BMS, Astellas, Gilead, INCYTE; Financial Interests, Invited Speaker: MSD, Astellas, Gilead/Immunomedics, Tahio; Financial Interests, Personal, Invited Speaker: Basilea; Non-Financial Interests, Member: ESMO, ASCO, AACR; Non-Financial Interests, Other, Scientific Committee: ARC. All other authors have declared no conflicts of interest.