LEPU BIO (02157): 2026 ESMO Congress Data Readout: CMG901 (AZD0901) Clinical Results Reported as an LBA Preferred Paper at the Presidential Symposium

LEPU BIO (02157) announced that the results of the Phase III clinical trial of CMG901 (AZD0901) for second-line and later-line (2L+) CLDN18.2-positive advanced/metastatic gastroesophageal cancer (GEC); the latest clinical results of MRG007 (ARR-217) (a potential best-in-class CDH17-targeting exatecan antibody-drug conjugate (ADC) for the treatment of colorectal cancer (CRC)); and the results of the Phase II trial of the PD-1 inhibitor pucotenlimab (HX008) combined with MRG003 (becotatug) as induction therapy for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The Board is pleased to announce that the global Phase III clinical trial CLARITY-Gastric01 (CG-01) has achieved positive topline results: compared with the investigator's choice regimen (INV), sonesitatug vedotin (Sone-Ve) demonstrated a significant overall survival (OS) benefit in both the third-line and later-line (3L+) population and the intent-to-treat (ITT) population, with a manageable safety profile. The above study results support that Sone-Ve has the potential to become a second-line and later-line treatment option for a broader population of patients with advanced CLDN18.2-positive GEC. The Board is pleased to announce that the ongoing Phase I study of MRG007 (ARR-217) has shown positive preliminary results; in patients with advanced or metastatic CRC, pharmacokinetics were observed to be dose-proportional, with improved stability, while demonstrating good preliminary antitumor activity and a manageable safety profile, supporting further clinical development and the ongoing Phase Ib dose optimization. The study covers patients with locally advanced or metastatic solid tumors, including CRC and other gastrointestinal (GI) malignancies that have progressed after standard treatment. The Board is also pleased to announce that the first interim safety analysis results of MRG003 (becotatug) in the GORTEC 2024-03 IDEAL trial are encouraging and show a good safety profile. The trial is a randomized Phase II clinical trial of (a) the PD-1 inhibitor pucotenlimab (HX008) combined with MRG003 (Arm A) versus (b) MRG003 monotherapy (Arm B) as induction therapy followed by sequential chemoradiotherapy (CRT). The trial is designed to evaluate the efficacy and safety of induction therapy with becotatug with or without pucotenlimab prior to definitive CRT in patients with LA-HNSCC. Patients with LA-HNSCC (laryngeal cancer, hypopharyngeal cancer, oral cavity cancer, and oropharyngeal cancer, both p16-negative and p16-positive) were randomized 1:1 to the above two arms. The primary endpoint of the clinical trial is the complete response rate (CR) at 12 weeks after CRT. The two arms are evaluated independently (using a single-stage Fleming design; the CR rate under the null hypothesis is 30%), with a planned total enrollment of 106 patients. The first interim safety analysis was conducted after the first 20 patients completed Cycle 1 treatment.