Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis.

Abstract

BACKGROUND:

The phase 3 JAVELIN Bladder 100 trial showed significantly prolonged overall survival (OS) with avelumab as first-line (1L) maintenance therapy + best supportive care (BSC) vs BSC alone in patients with advanced urothelial carcinoma (UC) that had not progressed with 1L platinum-containing chemotherapy. Efficacy and safety were assessed in patients enrolled in Japan.

METHODS:

Patients with locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L platinum-containing chemotherapy were randomized to avelumab (10 mg/kg intravenously every 2 weeks) + BSC or BSC alone. The primary endpoint was OS, and secondary endpoints included progression-free survival (PFS) and safety.

RESULTS:

In Japanese patients (n = 73) randomized to avelumab + BSC (n = 36) or BSC alone (n = 37), median OS was 24.7 months (95% CI, 18.2-not estimable) vs 18.7 months (95% CI, 12.8-33.0), respectively (HR, 0.81 [95% CI, 0.41-1.58]), and median PFS was 5.6 months (95% CI, 1.9-9.4) vs 1.9 months (95% CI, 1.9-3.8), respectively (HR, 0.63 [95% CI, 0.36-1.11]). In the avelumab + BSC and BSC-alone arms, grade ≥ 3 treatment-emergent adverse events (AEs) occurred in 50.0% vs 8.1%, including grade ≥ 3 treatment-related AEs in 13.9% vs 0%, respectively. Efficacy and safety results in Japanese patients were generally consistent with findings in the overall trial population.

CONCLUSION:

Avelumab 1L maintenance treatment showed a favorable benefit-risk balance in Japanese patients, supporting avelumab 1L maintenance as a new standard of care in Japanese patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy.

TRIAL REGISTRATION:

Clinicaltrials.gov NCT02603432.

• Authors: Yoshihiko Tomita, Yoshiaki Yamamoto, Norihiko Tsuchiya, Hiroomi Kanayama, Masatoshi Eto, Hideaki Miyake, Thomas Powles, Mizuki Yoshida, Yuichiro Koide, Yoshiko Umeyama, Alessandra di Pietro, Hirotsugu Uemura
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 27 Issue 2 Pg. 383-395 (Feb 2022) ISSN: 1437-7772 [Electronic] Japan
• PMID: 34973108 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2021. The Author(s).

Chemical References

• Antibodies, Monoclonal, Humanized
• avelumab

Topics

• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Carcinoma, Transitional Cell (drug therapy)
• Humans
• Japan
• Urinary Bladder
• Urinary Bladder Neoplasms (drug therapy)