LaNova Medicines Announces Completion of Subject Enrollment in Phase III Clinical Trial of LM-302

LaNova Medicines Ltd. announced that tecotabart vedotin (research and development code: LM-302) "CLDN18.2 ADC", a national Category 1 innovative drug, has successfully completed patient enrollment in its Phase III registrational clinical trial (LM302-03-101) for the treatment of third-line and later CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Notably, LM-302 is the world's first CLDN18.2 ADC to complete enrollment in a registrational Phase III clinical trial.

LM-302 is an antibody-drug conjugate (ADC) targeting CLDN18.2. By specifically binding to CLDN18.2-positive tumor cells, LM-302 is internalized via endocytosis and subsequently releases a small molecule cytotoxic payload, thereby enabling precise and targeted tumor cell killing. As a potential first-in-class (FIC) therapy, LM-302 has demonstrated promising clinical development potential across various gastrointestinal tumors, including gastric cancer, pancreatic cancer and biliary tract cancer, and is expected to provide new treatment options for patients with low CLDN 18.2 expression and low PD-L1 expression.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, LaNova Medicines presented the latest results from a study evaluating LM-302 in combination with toripalimab for the treatment of gastric cancer ^[1]: among 41 efficacy-evaluable patients, the overall response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4%; among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR reached 96.9%. In the stratified analysis conducted based on PD-L1 expression, the ORR in patients with PD-L1 CPS <1 was 63.3% and the ORR in patients with CPS ≥1 was 77.8%. This results indicate that the LM-302 combination regimen demonstrated significant anti-tumor activity with a manageable safety profile in CLDN18.2-positive patients.

In addition to the ongoing Phase III registrational study in the third-line and later setting, LM-302 is planning to initiate another Phase III registrational clinical trial in China, in combination with a PD-1 monoclonal antibody, for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, further expanding its therapeutic potential in the field of gastric cancer. Moreover, multiple indications of LM-302 have been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and LM-302 has also received the Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA).

Leveraging Sino Biopharm Group's robust resource support and industrial capabilities, LaNova Medicines is accelerating the clinical translation and commercialization of innovative therapies, with a continued commitment to delivering high-quality and accessible treatment options to cancer patients worldwide.

Source:

[1] Haiping Jiang et al. Efficacy and safety of LM-302 (anti-claudin 18.2 ADC) in combination with anti-PD-1 therapy for advanced gastric, gastroesophageal junction cancer and esophageal adenocarcinoma: Early-phase study results.. J Clin Oncol 43, 4039-4039(2025).