1991P - Subgroup analyses of patients (pts) with advanced urothelial carcinoma (aUC) who had long-term progression-free survival (PFS) or overall survival (OS) with avelumab first-line maintenance (1LM) in the AVENANCE real-world study

Background

Avelumab 1LM is approved worldwide for pts with aUC without progression after 1L platinum-based chemotherapy (PBC) based on the JAVELIN Bladder 100 phase 3 trial. AVENANCE (NCT04822350), a noninterventional, ambispective study, showed the effectiveness and safety of avelumab 1LM in a real-world aUC population in France. We report analyses in subgroups defined by duration of PFS or OS.

Methods

Eligible pts had aUC, were progression free after 1L PBC, and had previous, ongoing, or planned avelumab 1LM treatment. The primary endpoint is OS. Here, characteristics of subgroups with short or long PFS (≤3 or ≥12 mo from avelumab 1LM start, respectively) or long OS (≥3 y from 1L PBC start) were analyzed.

Results

At data cutoff (Dec 7, 2023), median follow-up in the overall population (N=595) was 26.3 mo (95% CI, 24.9-27.1). 186 pts (31.3%) had short PFS, 171 (28.7%) had long PFS, and 75 (12.6%) had long OS. Pt characteristics in these subgroups were heterogeneous (Table). Compared with the short PFS subgroup, long PFS and long OS subgroups had slightly higher proportions of pts with ECOG performance status of 0, prior 1L cisplatin, or complete response to 1L PBC. In the short PFS, long PFS, and long OS subgroups, respectively, second-line treatment after avelumab was received by 135 (72.6%), 45 (26.3%), and 36 (48.0%), including enfortumab vedotin in 12 (6.5%), 21 (12.3%), and 11 (14.7%); PBC in 21 (11.3%), 12 (7.0%), and 11 (14.7%); and non-PBC in 92 (49.5%), 7 (4.1%), and 9 (12.0%).

Conclusions

Subgroup analyses from AVENANCE show that long-term PFS and OS with avelumab 1LM treatment occurred in 29% and 13% of real-world pts, respectively, including pts with varying characteristics and irrespective of 1L PBC regimen. These findings support the use of avelumab 1LM as a standard of care for pts with aUC who are progression free after 1L PBC. Table: 1991P

Clinical trial identification

NCT04822350; first posted March 30, 2021.

Editorial acknowledgement

Medical writing support was provided by Amy Davidson of Nucleus Global and was funded by Merck.

Legal entity responsible for the study

Merck.

Funding

This study was sponsored by Pfizer and was previously conducted under an alliance between Merck (CrossRef Funder ID: 10.13039/100009945) and Pfizer. This analysis was sponsored by Merck.

Disclosure

P. Barthelemy: Financial Interests, Personal, Advisory Role: Amgen, Bristol Myers Squibb, Ipsen, Janssen-Cilag, Merck, MSD, Pfizer; Financial Interests, Personal, Other, Travel and accommodations expenses: Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen-Cilag, MSD, Pfizer; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen-Cilag, Merck, MSD, Novartis, Pfizer, Seagen. J. Eymard: Financial Interests, Personal, Advisory Role: Astellas Pharma, Ipsen, Janssen, Sanofi; Financial Interests, Institutional, Research Funding: Bristol Myers Squibb, Ipsen, Pfizer. A. Flechon: Financial Interests, Personal, Other, Travel and accommodations expenses: AAA HealthCare, Astellas Pharma, Bayer, Bristol Myers Squibb, Ipsen, Janssen-Cilag, MSD, Pfizer, Roche/Genentech, Sanofi/Aventis; Financial Interests, Personal, Other, Honoraria: AAA HealthCare, Astellas Pharma, Bayer, Bristol Myers Squibb, Ipsen, Janssen-Cilag, MSD, Pfizer, Roche/Genentech, Sanofi/Aventis. M. Gross Goupil: Financial Interests, Personal, Advisory Role: Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen, Eisai, Janssen-Cilag, Merck, MSD, Pfizer; Financial Interests, Personal, Other, Travel and accommodations expenses: Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen-Cilag, Merck, MSD, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, Janssen. Y. Loriot: Financial Interests, Personal, Advisory Role: Astellas Pharma, Bristol Myers Squibb, Immunomedics, Janssen, Loxo/Lilly, Merck, MSD, Pfizer, Roche, Seagen, Taiho Pharmaceutical; Financial Interests, Personal, Other, Travel and accommodations expenses: Astellas Pharma, Janssen Oncology, MSD, Roche, Seagen; Financial Interests, Institutional, Research Funding: Astellas Pharma, Basilea, Bristol Myers Squibb, Exelixis, Gilead Sciences, Incyte, Janssen Oncology, Merck, MSD, Nektar, Pfizer, Roche, Sanofi, Seagen, Taiho Pharmaceutical. A. Gobert: Financial Interests, Personal, Advisory Role: Astellas Pharma, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, Sanofi; Financial Interests, Personal, Other, Travel and accommodations expenses: Merck, Pfizer, Sanofi. M. Chasseray: Financial Interests, Advisory Role: Merck; Financial Interests, Other, Travel and accommodations expenses: Astellas Pharma, Daiichi Sankyo, Ipsen, Lilly, Merck; Financial Interests, Other, Honoraria: AstraZeneca, Merck. E. Kazan: Financial Interests, Personal, Other, Travel and accommodations expenses: Astellas, Bristol Myers Squibb, Gilead, Ipsen, Janssen, Merck, MSD, Pfizer, Roche, Sanofi. C. Josse: Financial Interests, Personal, Full or part-time Employment: eXYSTAT ; Financial Interests, Institutional, Research Funding: Merck, Pfizer. P. Lambert: Financial Interests, Personal, Full or part-time Employment: Pfizer. L. Paret: Financial Interests, Personal, Full or part-time Employment: Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA. C. Thibault: Financial Interests, Personal, Advisory Role: AAA HealthCare, AstraZeneca, Bristol Myers Squibb, Ipsen, Merck, MSD, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, MSD, Sanofi; Financial Interests, Institutional, Research Funding: AstraZeneca, Sanofi. All other authors have declared no conflicts of interest.