LEPU BIO (02157.HK): CMG901 Phase III meets primary endpoint, 3L gastric cancer OS 10.0 vs 5.0 months

NewTimeSpace News: On October 26, 2026, LEPU Bio (LEPU BIO, 02157.HK) announced three sets of clinical data presented at the 2026 ESMO Congress: Phase III results of CMG901 (AZD0901) in second-line or later CLDN18.2-positive advanced gastroesophageal cancer, updated data for MRG007 (ARR-217) in colorectal cancer, and Phase II results of pucotenlimab plus MRG003 in locally advanced head and neck squamous cell carcinoma.

In the global Phase III CLARITY-Gastric01 study, 532 patients were randomised to sonesitatug vedotin 2.2mg/kg or investigator's choice (267 versus 265). Median OS in the third-line or later population was 10.0 months versus 5.0 months (HR 0.47; p<0.001), and 10.6 months versus 6.4 months in the ITT population (HR 0.58). BICR-assessed median PFS was 4.2 months versus 3.8 months (HR 0.77), which did not reach the statistical significance threshold.

MRG007, a CDH17-directed exatecan ADC, was studied in 123 patients, 113 of them with colorectal cancer; at 6mg/kg, the ORR was 44.8% and the DCR 93.1% among evaluable patients. In the GORTEC 2024-03 IDEAL trial of MRG003 (becotatug vedotin) with or without pucotenlimab, the first interim safety analysis of 20 patients showed no grade 4 treatment-emergent adverse events, and the preliminary ORR after induction was 71%.