Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC) patients harboring KRAS G12C mutations.
As of November 17, 2023, the open-label, multi-center, single-arm Phase II trial has enrolled 123 patients, all receiving garsorasib at a dosage of 600 mg BID, with a median follow-up of 7.9 months. Among patients with locally advanced or metastatic NSCLC who were previously treated with anti-PD-(L)1 and platinum-based chemotherapy, the trial reported an objective response rate (ORR) of 50%, a disease control rate (DCR) of 89%, a median duration of response (DOR) of 12.8 months, and a median progression-free survival (PFS) of 7.6 months. Garsorasib also demonstrated favorable safety profiles, showing good tolerance and controllability.
Garsorasib is the first KRAS G12C inhibitor to enter clinical trials in China and is currently undergoing global multi-center studies in the U.S., Australia, South Korea, mainland China, and Taiwan. Its targeted indications include NSCLC, colorectal cancer (CRC), and other cancers with KRAS G12C mutations. Sino Biopharmaceutical’s subsidiary, Chia Tai Tianqing, entered into a licensing agreement with InventisBio in August 2022, granting it exclusive rights for development, regulatory approval, manufacturing, and commercialization of the drug in mainland China. The company is now awaiting regulatory decisions for treating locally advanced or metastatic NSCLC with KRAS G12C mutations.- Flcube.com