GenFleet Therapeutics, a biotechnology company in the clinical stage, specialising in oncology and immunology therapies, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for GFH925 (IBI351).

Additionally, the NMPA has granted Priority Review designation to GFH925 for treating patients with advanced non-small cell lung cancer (NSCLC) carrying the KRAS G12C mutation, who have undergone at least one systemic therapy.

This marks a significant milestone as GFH925 becomes the first China-developed KRAS G12C inhibitor to have its NDA submission accepted and awarded Priority Review Designation by the NMPA.

Furthermore, GFH925 has received Breakthrough Therapy Designations this year for its efficacy in treating advanced KRAS G12C-mutant NSCLC patients who have received at least one systemic therapy, as well as colorectal carcinoma (CRC) patients who have undergone at least two systemic therapies.

The Priority Review designation is based on findings from a single-arm registrational Phase II study of GFH925 monotherapy, specifically focusing on advanced KRAS G12C-mutant NSCLC patients who either failed standard-of-care treatment or were intolerant of it in China (NCT05005234).

The results of this study will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.

The Phase I trial results of GFH925 were updated during an oral presentation at the 2023 AACR Annual Meeting.

As of the data cutoff date (10 February 2023), out of the 67 evaluable NSCLC patients, 41 achieved partial response (PR), with an investigator-assessed overall response rate (ORR) of 61.2% and disease control rate (DCR) of 92.5%.

Among the 30 patients with NSCLC treated at the recommended phase 2 dose of 600mg BID, a more favourable efficacy signal was observed, with an investigator-assessed ORR of 66.7% (confirmed ORR 53.3%) and DCR of 96.7%.

In the fight against NSCLC, a multi-centre trial of GFH925 and ERBITUX (cetuximab, EGFR inhibitor) has progressed to a Phase II study in Europe, demonstrating favourable safety and encouraging efficacy. The trial is led by Professor Rafael Rosell, a globally recognised expert in the field of lung cancer and has shown partial responses among advanced KRAS G12C-mutant patients.

In China, Innovent is also exploring the potential of IBI351 (GFH925) in combination therapies for previously untreated advanced NSCLC patients with the KRAS G12C mutation. Two Phase Ib studies of IBI351 (GFH925) in combination with cetuximab and sintilimab (TYVYT, PD-1 inhibitor) are currently underway.

GenFleet chief medical officer Yu Wang said: “GFH925 is GenFleet’s first NDA-stage product and becomes China’s first KRAS G12C inhibitor that receives NDA acceptance and Priority Review Designation.

“That demonstrates GFH925’s encouraging safety and efficacy in treating advanced NSCLC, and its potential in commercialisation in the future. Meanwhile, GenFleet’s combination study of GFH925 and cetuximab treating NSCLC in 1st line also progressed smoothly in Europe with preliminary results of good safety and efficacy.

“GenFleet will promote the advancement of more multiple-regional studies in monotherapy and combination therapies and we look forward to positive progress of this study and other studies of GFH925 conducted by Innovent.”