A number of Chinese pharmaceutical companies have shared updates on their pipeline developments at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Among them are CSPC Pharmaceutical Group Ltd (HKG: 1093), Alphamab Oncology (HKG: 9966), and Innovent Biologics Inc. (HKG: 1801).
CSPC’s CLDN18.2 ADC Demonstrates Promise in Phase I Study
CSPC’s antibody drug conjugate (ADC) SYSA1801 is being assessed in a multi-center Phase I study for safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy in advanced malignant solid tumors. As of November 5, 2022, 33 subjects were enrolled, including 26 with gastric cancer and 7 with pancreatic cancer. The study reported a 75.8% rate of treatment-related adverse events (TRAEs), with 24.2% experiencing grade 3 or above TRAEs. Efficacy was evaluated in 21 subjects, with an objective response rate (ORR) of 47.1% and a disease control rate (DCR) of 62.7% for gastric cancer patients. SYSA1801 is a potential first-in-class ADC linking a Claudin 18.2 antibody to the antineoplastic agent monomethyl auristatin E (MMAE).
Alphamab’s KN026/KN046 Combo Shows Positive Phase II Results
Alphamab Oncology presented positive Phase II data for the combination of KN026 and KN046 in the treatment of HER2-positive malignant solid tumors. The single-arm, open, multi-cohort, multi-center phase II clinical study KN026-203 included patients with HER2-positive gastric cancer/gastroesophageal junction cancer, breast cancer, and other HER2-positive solid tumors. As of November 10, 2022, the objective response rate (ORR) was 53.3%, the median duration of response (DOR) was 6.8 months, the median progression-free survival (PFS) was 5.6 months, and the 12-month survival rate reached 80.4%. The combination treatment demonstrated good overall safety, with no treatment-related deaths. KN046 is a bispecific antibody targeting both PD-1 and CTLA-4, while KN026 is a next-generation HER2-targeted therapy.
Innovent’s KRAS G12C Inhibitor Shows Efficacy in Two Phase I Studies
Innovent Biologics reported on two ongoing Phase I clinical studies assessing the safety and efficacy of IBI351 as a monotherapy in patients with advanced colorectal cancer (CRC) with KRAS G12C mutation. As of February 16, 2023, 54 subjects were enrolled, with the 600mg BID dose group achieving a 42.9% ORR and 88.1% DCR, along with a good tolerability profile. IBI351 (GFH925), a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc., obtained breakthrough therapy designation in China earlier this year.-Fineline Info & Tech
