China’s Center for Drug Evaluation (CDE) has granted approval for Jacobio Pharma’s registrational Phase III clinical trial of glecirasib plus JAB-3312 for treating non-small cell lung cancer (NSCLC).
Glecirasib is a Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C inhibitor, while JAB-3312 is a Src homology region 2-containing protein tyrosine phosphatase 2 (Shp2) inhibitor.
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Subjects are currently being enrolled for the trial, which is the first global Phase III study to explore a combination therapy involving an SHP2 inhibitor with a KRAS G12C inhibitor.
The active-controlled, randomised study will investigate the efficacy and safety of the combination regimen against the current standard first-line treatment, which includes PD-1 antibody and chemotherapy in NSCLC patients with KRAS G12C mutations.
Since starting clinical trials of SHP2 inhibitors in 2018, Jacobio Pharma has reported promising results.
In a subset of 129 NSCLC patients, 58 were first-line treatment subjects, including seven dose groups.
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By GlobalDataThe objective response rate (ORR) was 65.5%, while the disease control rate (DCR) reached 100%.
The ORR reached 86.7% in dose group patients who were given 800mg of glecirasib once daily and 2mg of JAB-3312 on an alternating weekly schedule.
To date, no KRAS G12C inhibitors have received approval as a first-line treatment for NSCLC.
Jacobio’s combination therapy, featuring both glecirasib and JAB-3312 as oral formulations, is the first to receive Phase III registration trial approval for dual oral inhibitors in first-line NSCLC treatment on a global scale.
The company is expanding its clinical trials for JAB-3312, testing it both as a monotherapy and in combination with glecirasib and other agents across China, the US and Europe.
In addition, its study of glecirasib for pancreatic cancer has become the first global KRAS G12C registrational clinical study after it was approved by the CDE in July last year.
