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.

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