Lepu Biotech (02157): The 2026 ESMO conference data read the clinical results of CMG901 (AZD0901) as an LBA preferred paper report at the chairman's seminar

Zhitong Finance App News, Lepu Biotech (02157) announced the latest clinical results of the phase III clinical trial results of CMG901 (AZD0901) for second-line and later-line (2L+) CLDN18.2 positive advanced/metastatic gastroesophageal cancer (GEC); MRG007 (ARR-217), a potentially best-in-class esiccan antibody conjugate (ADC) targeting CDH17 for the treatment of colorectal cancer (CRC); and the PD-1 inhibitor prutelimab (HX008) in combination with MRG003 (Vibe) Results of phase II trial of cotutamab) for induction treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

The Board is pleased to announce that the global phase III clinical trial of Clarity-gastric01 (CG-01) achieved positive top-line results: compared to the Investigator Choice Program (INV), sonesitatug vedotin (Sone-Ve) showed significant overall survival (OS) benefits in third-tier (3L+) people and those intending to treat (ITT), and that safety was manageable. The above findings support that Sone-VE is expected to be a more widely applicable second-line and post-line treatment option for patients with advanced CLDN18.2 positive GEC.

The Board is pleased to announce that the ongoing phase I study of MRG007 (ARR-217) showed positive preliminary results. In patients with advanced or metastatic CRC, pharmacokinetics were directly proportional to dose, improved stability, and showed good initial anti-tumor activity. The safety is controllable, which can support further clinical development and ongoing phase Ib dose optimization. The study covered patients with locally advanced or metastatic solid tumors, such as CRC and other gastrointestinal (GI) malignancies, whose disease progressed after standard treatment.

The Board is also pleased to announce that the results of the first interim safety analysis of MRG003 (vibecotolatumab) in the GORTEC 2024-03 IDEAL trial were encouraging and showed good safety. This trial is a randomized phase II clinical trial of (a) PD-1 inhibitor prutelimab (HX008) combined with MRG003 (group A) compared (b) sequential chemotherapy (CRT) after induction treatment with MRG003 alone (group B). The purpose of this trial is to evaluate the efficacy and safety of induction treatment with vibecotolatumab with or without pritrizumab prior to curative CRT in LA-HNSCC patients. LA-HNSCC (laryngeal cancer, hypopharyngeal cancer, oral cancer, and oropharyngeal cancer p16 negative and p16 positive) patients were randomly assigned 1:1 to the above two groups. The primary endpoint of this clinical trial was complete remission rate (CR) at 12 weeks after CRT. The two groups were independently assessed (using a single-stage Fleming design; the CR rate under the original hypothesis was 30%), and a total of 106 patients were planned to be enrolled. The first mid-term safety analysis was performed in the first 20 patients after completing the 1st cycle of treatment.