Jacobio Announces China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor Plus KRAS G12C Inhibitor

Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor entered into phase III study globally in combination with KRAS G12C inhibitor.

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

Jacobio initiated clinical trials of SHP2 inhibitors in 2018. Data presented by Jacobio in an oral presentation at the 2023 European Society for Medical Oncology Annual Meeting (ESMO 2023) showed that among 129 patients with non-small cell lung cancer, 58 patients were first-line treatment patients (including 7 dose groups), ORR (objective response rate) was 65.5% (38/58), and the DCR (disease control rate) was 100%. Among them, in the dose group of 800 mg (once daily) glecirasib and 2 mg JAB-3312 (once daily for 1 week on, then 1 week off), the ORR was 86.7% (13/15). This clinical study is continuing to enroll patients.

The KRAS G12C inhibitors currently on the market have not been approved as first-line non-small cell lung cancer treatments for KRAS G12C mutations. Jacobio’s JAB-3312 and glecirasib are both oral formulations, and the combination therapy is also the first approved Phase III registration clinical trial for dual oral inhibitors in the first-line treatment of non-small cell lung cancer worldwide.