- Astellas Pharma Canada presented real-world evidence at ESMO 2026 showing how a national pathway supported CLDN18.2 biomarker testing and access to zolbetuximab plus chemotherapy for eligible patients with advanced gastric or GEJ cancer.
- From May 2025 to January 2026, 63 patients across eight provinces received treatment through the patient support program. Zolbetuximab was used regardless of PD-L1 CPS, consistent with its Health Canada-authorized indication.
- By March 31, 2026, 13 validated centres had tested 1,576 samples. The mean turnaround time was 6.1 days, while the median CLDN18.2 positivity rate was 41%, highlighting the pathway’s reach and testing efficiency.
- The findings offer early insights into integrating biomarker-guided care in Canada before public reimbursement. Astellas said continued collaboration, clinical research and real-world evidence will help advance patient identification and targeted treatment.
Takeaways:
Astellas’ Canadian real-world evidence strengthens the implementation case for CLDN18.2-targeted therapy by demonstrating a testing network across 13 validated centres, with a 6.1-day mean turnaround time and 41% median positivity rate. This infrastructure could support wider zolbetuximab adoption, but integration into routine care, public reimbursement and broader clinical evidence will shape access and competitive positioning.
Source: Astellas
