Sino Biopharmaceutical Limited (“SBP Group”) reported Phase II data on tecotabart vedotin (LM-302), a CLDN18.2-targeting antibody–drug conjugate, at the 2026 American Society of Clinical Oncology Annual Meeting. The study evaluated LM-302 combined with a PD-1 monoclonal antibody, with or without chemotherapy, as first-line therapy for advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ).
A total of 71 patients were enrolled: 39 received the doublet regimen (LM-302 + PD-1) and 32 received the triplet regimen (LM-302 + PD-1 + chemotherapy). Low CLDN18.2 expression (≥25%) was present in 82.10% and 84.40% of the two cohorts, respectively. Median follow-up reached 18.73 months for the doublet arm and 16.21 months for the triplet arm.
Efficacy outcomes were broadly comparable between regimens. In the overall population, median progression-free survival (PFS) was 10.68 months for the doublet versus 12.55 months for the triplet. Among patients with low CLDN18.2 expression, median PFS was 15.18 months (doublet) and 15.21 months (triplet), while median overall survival (OS) stood at 18.30 months and 18.14 months, respectively. OS event rates were 45.20% (14/31) in the doublet group and 26.90% (7/26) in the triplet group.
Safety results favored the chemotherapy-free approach. Grade ≥3 treatment-related adverse events occurred in 66.70% of doublet patients compared with 81.30% in the triplet arm. Dose reductions due to treatment-emergent adverse events affected 17.90% versus 43.80% of patients, and treatment discontinuations occurred in 23.10% versus 31.30%, respectively. No treatment-related deaths were reported.
Given the balance of efficacy and superior tolerability, SBP Group has initiated the world’s first Phase III registrational trial (LM302-03-201) investigating a chemotherapy-free first-line regimen of LM-302 plus PD-1 for CLDN18.2-positive gastric cancer. The study began in April 2026 and aims to provide a durable, better-tolerated alternative to current chemotherapy-based standards.
Global gastric cancer incidence remains high at approximately 1.04 million new cases and 705,000 deaths annually, with China accounting for nearly 383,000 cases and 277,000 deaths. Current first-line chemotherapy-ICI combinations deliver median OS of roughly 14–20 months, underscoring the need for more effective and tolerable options—an unmet need the LM-302 regimen seeks to address.
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