1975P - Avelumab first-line (1L) maintenance in advanced urothelial carcinoma (aUC): Conditional survival and long-term safety in patients (pts) treated for ≥1 or ≥2 years in JAVELIN Bladder 100

Background

In the JAVELIN Bladder 100 phase 3 trial (NCT02603432), avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in pts with aUC that had not progressed with 1L platinum-based chemotherapy (PBC). Here, we report conditional survival estimates and safety in pts treated with avelumab for ≥1 or ≥2 years.

Methods

Eligible pts with unresectable locally advanced or metastatic UC without progression after 1L PBC were randomized 1:1 to receive avelumab + BSC (n=350) or BSC alone (n=350). The primary endpoint was OS (from randomization); secondary endpoints included PFS and safety.

Results

Among 350 pts randomized to avelumab + BSC, treatment duration was ≥1 year in 118 pts (33.7%) and ≥2 years in 68 (19.4%). Compared with the overall avelumab + BSC arm, a higher proportion of pts with ≥2 years of treatment had received 1L gemcitabine + cisplatin (64.7% vs 52.3%), had nonvisceral metastases (58.8% vs 45.4%), and had PD-L1+ tumors (64.7% vs 54.0%). In pts who received ≥1 year of treatment, the probability of surviving for an additional 1 or 1.5 years was 93.2% and 86.8%, respectively; the probability of surviving for an additional 6 months or 1 year without progression was 77.9% and 66.7%, respectively. In pts who received ≥2 years of treatment, the probability of surviving for an additional 1 or 1.5 years was 95.8% and 90.3%, respectively; the probability of surviving an additional 6 months or 1 year without progression was 82.9% and 66.7%, respectively. Among pts treated for ≥1 or ≥2 years, any-grade treatment-related adverse events (TRAEs) occurred after ≥1 year in 50.0% and after ≥2 years in 35.3%; grade ≥3 TRAEs occurred in 11.9% and 5.9%, respectively.

Conclusions

Pts with aUC who received ≥1 or ≥2 years of avelumab 1L maintenance treatment in JAVELIN Bladder 100 had a high probability of surviving for an additional 1 year or more. No new safety concerns were identified with longer treatment duration. These results can inform prognosis and further support avelumab 1L maintenance as a standard of care in pts with aUC without progression after 1L PBC.

Clinical trial identification

NCT02603432; first posted November 11, 2015.

Editorial acknowledgement

Medical writing support was provided by Sophie Saunders of Nucleus Global and was funded by Merck.

Legal entity responsible for the study

Merck.

Funding

This trial 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. Grivas: Financial Interests, Personal, Advisory Role: AADI, AbbVie, Asieris Pharmaceuticals, Astellas Pharma, AstraZeneca, BostonGene, Bristol Myers Squibb, CG Oncology, Fresenius Kabi, G1 Therapeutics, Gilead Sciences, lmmunityBio, Janssen, Lucence Health, Merck, MSD, Pfizer, PureTech, Roche, Seagen, Silverback Therapeutics, Strata Oncology; Financial Interests, Institutional, Research Funding: Acrivon Therapeutics, ALX Oncology, Bristol Myers Squibb, G1 Therapeutics, Genentech, Gilead Sciences, GSK, Merck, Mirati Therapeutics, MSD, Pfizer, QED Therapeutics. S.H. Park: Financial Interests, Personal, Other, Honoraria: Merck, Ono Pharmaceutical, Pfizer; Financial Interests, Personal, Advisory Role: Janssen Oncology; Financial Interests, Institutional, Research Funding: MSD. W. Demey: Financial Interests, Personal, Advisory Role: Pfizer, Merck. P.C. Fong: Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Other, Travel and accommodation expenses: Pfizer; Financial Interests, Institutional, Research Funding: MSD. J.A. Garcia: Financial Interests, Personal, Other, Personal fees: Aptitude Health, Pfizer, US Food and Drug Administration, MJH, Astellas. N. Jacob: Financial Interests, Personal, Full or part-time Employment: Merck. A. Gerhold-Ay: Financial Interests, Personal, Full or part-time Employment: 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. J. Hoffman: 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 or ownership: Merck, MSD, Pfizer. J. Bellmunt: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca/MedImmune, Bristol Myers Squibb, Genentech, Merck, Novartis, Pfizer, Pierre Fabre; Financial Interests, Personal, Other, Travel and accommodation expenses: Ipsen, MSD, Pfizer; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Personal, Stocks or ownership: Rainier Therapeutics; Financial Interests, Personal, Other, Honoraria: UpToDate; Financial Interests, Institutional, Research Funding: Merck, Millennium, Pfizer, Sanofi. T.B. Powles: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, MSD, Pfizer, Roche, Seagen, MashupMD; Financial Interests, Personal, Other, Travel and accommodations expenses: Pfizer, AstraZeneca, Ipsen, MSD, Pfizer, Roche; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson/Janssen, MashupMD, Merck, MSD, Novartis, Pfizer, Roche, Seagen; Financial Interests, Personal, Research Funding: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, MSD, Novartis, Pfizer, Roche, Seagen. All other authors have declared no conflicts of interest.