Core Viewpoint - The approval of JAB-3312, a SHP2 inhibitor developed by the company, for a Phase III clinical trial in combination with the KRAS G12C inhibitor, adagrasib, marks a significant milestone as it is the first SHP2 inhibitor to enter Phase III trials in combination with a KRAS G12C inhibitor globally [1]. Group 1: Clinical Trial Details - The approved study is a randomized positive control Phase III clinical trial aimed at evaluating the efficacy and safety of JAB-3312 combined with adagrasib in first-line non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations [1]. - The control group for this trial consists of the current standard treatment for first-line NSCLC, which includes PD-1 antibodies and chemotherapy [1]. Group 2: Clinical Data and Efficacy - The clinical trial for the SHP2 inhibitor was initiated in 2018, and data presented at the ESMO 2023 conference showed an objective response rate (ORR) of 65.5% (38 out of 58 patients) and a disease control rate (DCR) of 100% among 129 NSCLC patients [1]. - In the specific dosage group of 800 mg adagrasib (once daily) and 2 mg JAB-3312 (once daily, with a week on and a week off regimen), the ORR reached 86.7% (13 out of 15 patients) [1]. Group 3: Market Position and Innovation - Currently, no KRAS G12C inhibitors have been approved as first-line therapies for KRAS G12C mutated non-small cell lung cancer, positioning the company's JAB-3312 and adagrasib as innovative oral formulations [1]. - This combination therapy represents the first clinical trial globally to receive approval for a dual oral inhibitor regimen in the first-line treatment of non-small cell lung cancer [1].
加科思-B(01167)：SHP2抑制剂JAB-3312与KRAS G12C抑制剂戈来雷塞联用注册性三期临床研究获CDE批准