Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis
- PMID: 37019764
- DOI: 10.1016/j.urolonc.2023.02.002
Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis
Abstract
Background: The phase 3 JAVELIN Bladder 100 trial showed significantly prolonged overall survival (OS) with avelumab first-line maintenance + best supportive care (BSC) vs. BSC alone in patients with advanced urothelial carcinoma (UC) that had not progressed with first-line platinum-containing chemotherapy. Here, efficacy and safety were assessed from the initial analysis of the JAVELIN Bladder 100 trial (data cutoff October 21, 2019) in patients enrolled in Asian countries.
Methods: Patients with locally advanced or metastatic UC that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy (gemcitabine + cisplatin or carboplatin) were randomized 1:1 to receive avelumab first-line maintenance + BSC or BSC alone, stratified by best response to first-line chemotherapy and visceral vs. nonvisceral disease when initiating first-line chemotherapy. The primary endpoint was OS assessed from randomization in all patients and patients with PD-L1+ tumors (Ventana SP263 assay). Secondary endpoints included progression-free survival (PFS) and safety.
Results: A total of 147 patients in JAVELIN Bladder 100 were enrolled in Asian countries (Hong Kong, India, Japan, South Korea, and Taiwan). In this Asian subgroup, 73 and 74 patients received avelumab + BSC or BSC alone, respectively. Median OS was 25.3 months (95% CI, 18.6 to not estimable [NE]) in the avelumab + BSC arm vs. 18.7 months (95% CI, 12.8-NE) in the BSC alone arm (hazard ratio [HR], 0.74 [95% CI, 0.43-1.26]); 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, 0.38-0.86]). In the avelumab + BSC vs. BSC alone arms, grade ≥3 treatment-emergent adverse events (any causality) occurred in 44.4% vs. 16.2%, respectively. The most common grade ≥3 treatment-emergent adverse events in the avelumab + BSC arm were anemia (9.7%), amylase increased (5.6%), and urinary tract infection (4.2%).
Conclusions: Efficacy and safety results for avelumab first-line maintenance in the Asian subgroup of JAVELIN Bladder 100 were generally consistent with those in the overall trial population. These data support the use of avelumab first-line maintenance as standard of care for Asian patients with advanced UC that has not progressed with first-line platinum-containing chemotherapy. NCT02603432.
Keywords: Advanced urothelial carcinoma; Asia; Avelumab; Immune checkpoint inhibitors; Immunotherapy; Maintenance treatment.
Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest J.-L. Lee reports stock and other ownership interests in Amgen, BeiGene, Black Diamond Therapeutics, Innovent Biologics, Johnson & Johnson/Janssen, Karyopharm Therapeutics, Myovant Sciences, the healthcare business of Merck KGaA, Darmstadt, Germany, and Zymeworks; has received honoraria from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Merck & Co., Kenilworth, NJ, and Pfizer; served in a consulting or advisory role for AstraZeneca, Bristol Myers Squibb, GI Innovation, Merck & Co., Kenilworth, NJ, Oscotec, Pfizer, Sanofi Korea, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has received research funding from Amgen, AstraZeneca/MedImmune, Bayer Schering Pharma, Bristol Myers Squibb, GI Innovation, Janssen, Merck & Co., Kenilworth, NJ, Novartis, Pfizer, Roche/Genentech, and Seagen. C. Desai has served in a consulting or advisory role for Novartis, Pfizer, Roche, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has provided speakers services for Dr. Reddy's, Lupin Pharmaceuticals, Novartis, and Pfizer. S. H. Park has served in a consulting or advisory role for Janssen Oncology; has received honoraria from Ono Pharma Korea, Pfizer, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has received research funding from Ono Pharmaceutical and Sanofi. N. Tsuchiya has received honoraria from Astellas, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck & Co., Kenilworth, NJ, Pfizer, Takeda, and the healthcare business of Merck, KGaA, Darmstadt, Germany; and has received institutional research funding from Eisai. P.-J. Su has served in a consulting or advisory role for Bristol Myers Squibb, Merck & Co., Kenilworth, NJ, Ono Pharmaceutical, Pfizer, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has provided speakers services for Bristol Myers Squibb, Merck & Co., Kenilworth, NJ, Ono Pharmaceutical, Pfizer, Roche, and the healthcare business of Merck KGaA, Darmstadt, Germany. T. T. W. Chan has nothing to disclose. H. Gurney has served in consulting or advisory roles for AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen-Cilag, Merck & Co., Kenilworth, NJ, Pfizer, Roche, and the healthcare business of Merck KGaA, Darmstadt, Germany; reports speakers services for the healthcare business of Merck KGaA, Darmstadt, Germany; and has received travel and accommodations expenses from AstraZeneca. S. Gao reports employment by Merck Pte. Ltd., Singapore, an affiliate of Merck KGaA, Darmstadt, Germany at the time the research was conducted. J. Wang reports employment by Pfizer. R. Sandner reports employment by and stock and other ownership interests in Pfizer. A. di Pietro reports employment by and stock and other ownership interests in Pfizer. M. Eto has served in a consulting or advisory role for AstraZeneca, Bristol Myers Squibb, Chugai Pharma, Eisai, Johnson & Johnson, Ono Pharmaceutical, Pfizer, Takeda, and the healthcare business of Merck KGaA, Darmstadt, Germany; has provided speakers services for Bristol Myers Squibb, Janssen, Merck & Co., Kenilworth, NJ, Novartis, Ono Pharmaceutical, Pfizer, Takeda, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has received research funding from Astellas Pharma, Bayer, Ono Pharmaceutical, Sanofi, and Takeda.
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