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. 2025 Nov 17.
doi: 10.1111/ajco.70042. Online ahead of print.

Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Real-World Results From an Early Access Program in Malaysia

Fuad Bin Ismail  1 , Mohamed Ibrahim Abdul Wahid  2 , Muthukkumaran Thiagarajan  3 , Ai Lian Tan  4 , Nellie Lay Chin Cheah  5 , Kai Seng Lam  6 , Doris Sze Ying Chow  7 , Soo Fan Ang  8 , Michelle Ng  9 , Hannah Loke  10 , John Seng Hooi Low  11
Affiliations

Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Real-World Results From an Early Access Program in Malaysia

Fuad Bin Ismail et al. Asia Pac J Clin Oncol. .

Abstract

Aim: Avelumab first-line (1L) maintenance was approved for treatment of advanced urothelial carcinoma (UC) based on results from the JAVELIN Bladder 100 Phase 3 trial. We report real-world data from an early access program (EAP) for avelumab 1L maintenance treatment in Malaysia.

Methods: Data from patients with locally advanced or metastatic UC who received ≥ 1 dose of avelumab 1L maintenance treatment between September 2021 and January 2023 were obtained retrospectively. Patient and treatment characteristics, best response to treatment, and safety were assessed.

Results: Data were provided from 13 patients treated at 9 hospitals in Malaysia. Seven patients (53.8%) were female, and ECOG performance status prior to 1L chemotherapy was 0-1 in 11 patients (84.6%) and 2 in 2 patients (15.4%). Chemotherapy included cisplatin in 6 patients (46.2%) and carboplatin in 7 patients (53.8%), and the best response was complete response in 1 patient (7.7%), partial response in 7 patients (53.8%), and stable disease in 5 patients (38.5%). The median duration of avelumab treatment was 9 months, with treatment ongoing in 4 patients (30.8%) at last follow-up. The objective response rate was 30.8% and an additional 5 patients (38.5%) had stable disease as the best response. Median PFS was 10.4 months. Reasons for discontinuation were disease progression in 8 patients (61.5%) and patient withdrawal in 1 patient (7.7%). Treatment-related adverse events occurred in 3 patients (23.1%) and were grade 2 in 1 patient (7.7%) and grade 1 in 2 (15.4%).

Conclusions: Data from this small EAP population support the use of avelumab 1L maintenance treatment in patients with advanced UC in Malaysia.

Keywords: Malaysia; avelumab; early access program; maintenance; urothelial carcinoma.

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