Sino Biopharmaceutical Limited announced that its wholly-owned subsidiary, Livzon Pharmaceutical Group Science & Technology Development Co., Ltd., presented Phase II clinical data for its self-developed innovative drug, Vitakto Baisingle Antibody "CLDN18.2 ADC" (R&D code: LM-302), at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data is for first-line treatment of gastric or gastroesophageal junction adenocarcinoma. Results showed that LM-302 combined with a PD-1 inhibitor (with or without chemotherapy) demonstrated encouraging anti-tumor activity and manageable safety in the first-line treatment of CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Notably, the LM-302 plus PD-1 inhibitor dual-therapy regimen showed efficacy comparable to the triple-therapy regimen, with superior tolerability, supporting further large-scale clinical studies. The study enrolled 71 patients with gastric or gastroesophageal junction adenocarcinoma, including 39 in the dual-therapy cohort (LM-302 + PD-1) and 32 in the triple-therapy cohort (LM-302 + PD-1 + chemotherapy). The proportion of patients with CLDN18.2 low-expression threshold positivity (≥25%) was 82.1% and 84.4% in the two groups, respectively, with median follow-up durations of 18.73 months and 16.21 months. In the overall population, the median progression-free survival (PFS) was 10.68 months for the dual-therapy group and 12.55 months for the triple-therapy group. Among patients with CLDN18.2 low-expression threshold positivity (≥25%), the median PFS for the dual and triple regimens was 15.18 months and 15.21 months, respectively, and median overall survival (OS) was 18.30 months and 18.14 months, respectively. The OS event rates were 45.2% (14/31) and 26.9% (7/26) for the two groups, indicating largely comparable efficacy. No treatment-related deaths were reported in either group. The incidence of grade ≥3 treatment-related adverse events was 66.7% in the dual-therapy group and 81.3% in the triple-therapy group. The proportion of adverse events leading to dose reduction during treatment was 17.9% and 43.8%, respectively, and the proportion leading to treatment discontinuation was 23.1% and 31.3%, respectively. Compared to the triple regimen, the LM-302 + PD-1 dual regimen demonstrated superior tolerability while maintaining similar efficacy. Based on the positive results of this study, the world's first Phase III registration clinical study for first-line "chemotherapy-free" gastric cancer treatment (LM302-03-201) was officially launched in April 2026. It aims to explore LM-302 combined with PD-1 as an alternative to traditional chemotherapy, offering a new first-line treatment option for CLDN18.2-positive gastric cancer patients that provides long-term efficacy, better tolerability, and a higher quality of life.
Comments