Pharma Focus Asia

Jacobio Secures China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor and KRAS G12C Inhibitor Combination

Monday, February 19, 2024

Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on previously challenging targets, has announced the approval of a registrational phase III clinical trial for the combination therapy of its novel KRAS G12C inhibitor, glecirasib, and the novel SHP2 inhibitor, JAB-3312. This marks the first phase III study globally for a SHP2 inhibitor in combination with a KRAS G12C inhibitor.

The approved trial in China will be a randomized active controlled phase III trial designed to assess the efficacy and safety of JAB-3312 in combination with glecirasib as a first-line treatment for non-small cell lung cancer patients with KRAS G12C mutations. The control arm will consist of the current standard treatment for first-line non-small cell lung cancer, which is a combination therapy of PD-1 antibody and chemotherapy.

Jacobio initiated clinical trials of SHP2 inhibitors in 2018, and data presented at the 2023 European Society for Medical Oncology Annual Meeting (ESMO 2023) showed promising results. Among 129 patients with non-small cell lung cancer, the objective response rate (ORR) was 65.5% and the disease control rate (DCR) was 100%. Notably, in the dose group receiving 800 mg of glecirasib and 2 mg of JAB-3312, the ORR was 86.7%. Enrollment for this clinical study is ongoing.

Currently, KRAS G12C inhibitors on the market have not been approved as first-line treatments for non-small cell lung cancer with KRAS G12C mutations. Both JAB-3312 and glecirasib are administered orally, and their combination therapy represents the first approved Phase III registration clinical trial for dual oral inhibitors in the first-line treatment of non-small cell lung cancer worldwide.

JAB-3312 is described as a highly selective SHP2 allosteric inhibitor with significant potential, while glecirasib is a KRAS G12C inhibitor developed by Jacobio. Numerous Phase I/II clinical trials for glecirasib are currently ongoing globally, including pivotal trials in NSCLC in China, a monotherapy study for STK11 co-mutated NSCLC, and combination therapy trials with JAB-3312 in NSCLC and with Cetuximab in colorectal cancer.



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