2371P - Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in older patients (pts)

Background

In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab 1L maintenance therapy + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in pts with aUC without progression following 1L platinum-based chemotherapy. After ≥2 years of follow-up in all pts, median OS was 23.8 months (95% CI, 19.9-28.8) vs 15.0 months (95% CI, 13.5-18.2), respectively. Avelumab 1L maintenance also had minimal impact on quality of life. Here, we report long-term efficacy and safety outcomes in subgroups based on older age (≥65 years).

Methods

Eligible pts with locally advanced or metastatic UC without progression following 4 to 6 cycles of 1L platinum-based chemotherapy were randomized 1:1 to receive avelumab + BSC (n=350) or BSC alone (n=350). The primary endpoint was OS; secondary endpoints included PFS and safety. For this post hoc analysis, subgroups aged ≥65 to <75 years, ≥75 years, and ≥80 years were analyzed. Pts aged <65 years were not included in this analysis.

Results

At data cutoff (June 4, 2021), median follow-up in both arms was ≥38 months. In the avelumab + BSC and BSC alone arms, age was ≥65 to <75 years in 136 and 163 pts, ≥75 years in 85 and 80 pts, and ≥80 years in 28 and 27 pts, respectively. Across all subgroups, OS and PFS were prolonged with avelumab + BSC vs BSC alone (Table). The table also shows incidence of any-grade and grade ≥3 treatment-related adverse events (TRAEs) in the subgroups.

Conclusions

Long-term outcomes from JAVELIN Bladder 100 confirm prolonged OS and PFS with avelumab + BSC vs BSC alone in older pts. Long-term safety of avelumab 1L maintenance was similar across subgroups, confirming its tolerability. These findings provide further support for avelumab 1L maintenance as standard of care in pts with aUC without progression following 1L platinum-based chemotherapy, including older pts over 65 years old. Table: 2371P

NE, not estimable.∗In treated pts.

Clinical trial identification

NCT02603432; First posted: November 11, 2015.

Editorial acknowledgement

Medical writing support was provided by Lauren O’Brien on behalf of Clinical Thinking and funded by Pfizer and Merck.

Legal entity responsible for the study

The authors.

Funding

This trial was sponsored by Pfizer, as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945). This analysis was sponsored by Merck.

Disclosure

S. Gupta: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Gilead Sciences, Guardant Health, AVEO, Merck, Pfizer, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Loxo, Lilly, Bayer; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb, Janssen Oncology, Seagen, Gilead Sciences; Financial Interests, Personal, Stocks/Shares: Nektar, Moderna, BioNTech. M.A. Climent Duran: Financial Interests, Personal, Advisory Role: Astellas Pharma, Bayer, Bristol Myers Squibb, Celgene, Eisai, EUSA Pharma, Janssen-Cilag, MSD, Pfizer, Roche/Genentech, Sanofi, Merck; Financial Interests, Personal, Other, Travel and Accommodation Expenses: Ipsen, Janssen, Pfizer, Roche, Merck; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai Europe, EUSA Pharma, Ipsen, Janssen, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, Merck; Financial Interests, Personal, Advisory Board: Janssen Oncology. S. Sridhar: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, MSD, Pfizer, Roche/Genentech, Seagen; Financial Interests, Institutional, Funding: Bayer, Janssen, Pfizer. T.B. Powles: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, AstraZeneca, Ipsen, Pfizer, Novartis, Incyte, Seagen, Roche, Exelixis, MSD, Merck, Astellas Pharma, Johnson & Johnson, Eisai; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Pfizer. J. Bellmunt: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca/MedImmune, Bristol Myers Squibb, Genentech, Novartis, Pfizer, Pierre Fabre, Merck; Financial Interests, Personal, Other, Travel and Accommodation Expenses: Ipsen, MSD, Pfizer; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Personal, Stocks/Shares: Rainier Therapeutics; Financial Interests, Personal, Other, Honoraria: UpToDate; Financial Interests, Institutional, Funding: Millennium, Pfizer, Sanofi, Merck. K. Tyroller: Financial Interests, Personal, Full or part-time Employment: EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; Financial Interests, Personal, Stocks/Shares: Merck. S. Guenther: Financial Interests, Personal, Full or part-time Employment: Merck; Financial Interests, Personal, Stocks/Shares: Merck. A. di Pietro: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer; Financial Interests, Personal, Other, Honoraria: Pfizer. P. Grivas: Financial Interests, Personal, Advisory Role: 4D Pharma, Aadi Bioscience, Astellas Pharma, Asieris Pharmaceuticals, AstraZeneca, BostonGene, Bristol Myers Squibb, CG Oncology, Dyania Health, Exelixis, Fresenius Kabi, Genentech/Roche, Gilead Sciences, Guardant Health, ImmunityBio, Infinity Pharmaceuticals, Janssen, Lucence, Merck, Mirati Therapeutics, MSD, Pfizer, PureTech Health, QED Therapeutics, Regeneron, Roche, Seagen, Silverback Therapeutics, Strata Oncology, UroGen Pharma; Financial Interests, Institutional, Funding: Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm Group, G1 Therapeutics, Gilead Sciences, GSK, Merck, Mirati Therapeutics, MSD, Pfizer, QED Therapeutics; Financial Interests, Personal, Advisory Board: G1 Therapeutics.