137MO - Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Longer-term follow-up from the Asian subgroup of the JAVELIN Bladder 100 trial

Background

In the JAVELIN Bladder 100 trial (NCT02603432), avelumab (anti–PD-L1) 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in patients with advanced UC that had not progressed with 1L platinum-based chemotherapy. Previously reported initial data from patients enrolled in Asia were consistent with data from the overall trial population. Here, we report longer-term efficacy and safety data from the Asian subgroup.

Methods

Patients with locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L platinum-based chemotherapy were randomized 1:1 to receive avelumab 1L maintenance (10 mg/kg every 2 weeks) + BSC or BSC alone, stratified by best response to 1L chemotherapy and visceral vs nonvisceral disease at the start of 1L chemotherapy. The primary endpoint was OS.

Results

Of 147 patients enrolled in Asia (Hong Kong, India, Japan, South Korea, and Taiwan); 73 and 74 were randomized to receive avelumab + BSC or BSC alone, respectively. At data cutoff (June 4, 2021; ≥2 years follow-up in all patients), median duration of avelumab treatment was 40.2 weeks (range, 2.0-194.0). In the avelumab + BSC vs BSC alone arms, median OS was 28.7 months (95% CI, 18.9-37.0) vs 18.2 months (95% CI, 13.4-31.2), and 2-year OS rates were 60.7% vs 43.5%, respectively; the HR for OS was 0.78 (95% CI, 0.509-1.185). Median PFS was 5.6 months (95% CI, 2.0-7.5) vs 1.9 months (95% CI, 1.9-1.9), respectively (HR 0.58 [95% CI, 0.383-0.864]). Grade ≥3 treatment-emergent adverse events occurred in 36 patients (50.0%) in the avelumab + BSC arm and 11 patients (14.9%) in the BSC alone arm. Immune-related adverse events of any grade occurred in 23 patients (31.9%) in the avelumab + BSC arm.

Conclusions

Longer-term follow-up from the Asian subgroup of JAVELIN Bladder 100 continues to show prolonged OS and PFS with avelumab 1L maintenance + BSC vs BSC alone, and safety findings were consistent with initial trial data. These findings further support the use of avelumab 1L maintenance as standard of care in Asian patients with advanced UC that has not progressed with 1L platinum-based chemotherapy.

Clinical trial identification

NCT02603432, first posted November 11, 2015.

Editorial acknowledgement

Medical writing support was provided by Sophie Saunders 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

Pfizer as part of an alliance between Pfizer and Merck.

Funding

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

Disclosure

M. Eto: Financial Interests, Personal, Other, Speaker’s Bureau: MSD, Ono, Takeda, Merck; Financial Interests, Personal, Research Grant: Sanofi, Ono, Takeda. C.J. Desai: Financial Interests, Personal, Advisory Role: Pfizer, Merck, Roche, Novartis; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Novartis, Lupin, Dr. Reddy's. S.H. Park: Financial Interests, Personal, Advisory Role: Janssen Oncology, Merck, Pfizer, Ono Pharma Korea; Financial Interests, Personal, Sponsor/Funding: Ono Pharmaceutical, Sanofi. N. Tsuchiya: Financial Interests, Personal, Sponsor/Funding: Eisai; Financial Interests, Personal, Other, Honoraria: Astellas, Pfizer, Merck, Bayer, Eisai, Takeda, Janssen, MSD, Bristol Myers Squibb. P.J. Su: Financial Interests, Personal, Advisory Role: Pfizer, Merck, Bristol Myers Squibb, Ono Pharmaceuticals, MSD; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Merck, Bristol Myers Squibb, Ono Pharmaceuticals, MSD, Roche. H.P. Gurney: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Ipsen, MSD, AstraZeneca, Janssen-Cilag, Pfizer, Roche, Merck, Astellas; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca. S. Gao: Financial Interests, Personal, Full or part-time Employment: Merck. J. Wang, R. Sandner: Financial Interests, Personal, Full or part-time Employment: Pfizer. A. di Pietro: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. J. Lee: Financial Interests, Personal, Advisory Role: Pfizer, Bristol Myers Squibb, GI Innovation, MSD, Merck, AstraZeneca, Sanofi Korea, Oscotec Inc.; Financial Interests, Personal, Stocks/Shares: Myovant Sciences, Johnson & Johnson/Janssen, Amgen, Merck, BeiGene, Innovent Biologics, Black Diamond Therapeutics, Karyopharm Therapeutics, Zymeworks; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb, Astellas Pharma, Pfizer, AstraZeneca, MSD; Financial Interests, Institutional, Sponsor/Funding Pfizer, Janssen, Novartis, Bristol Myers Squibb, Roche/Genentech, AstraZeneca/MedImmune, MSD, Bayer Schering Pharma, Seagen, GI Innovation, Amgen. All other authors have declared no conflicts of interest.