GenFleet Therapeutics, a clinical-stage biotechnology company specializing in cutting-edge therapies in oncology and immunology, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for GFH925 (IBI351) and granted GFH925 Priority Review designation. This marks the first acceptance of an NDA submission for a China-developed KRAS G12C inhibitor, with the added distinction of receiving Priority Review Designation from NMPA. Additionally, GFH925 has received Breakthrough Therapy Designations this year for treating advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients who have undergone at least one systemic therapy and colorectal carcinoma (CRC) patients who have received at least two systemic therapies.
The Priority Review designation is based on results from a single-arm registrational Phase II study of GFH925 monotherapy, targeting advanced KRAS G12C-mutant NSCLC patients who have failed or were intolerant of standard-of-care treatment in China (NCT05005234). These results will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.
An oral presentation at the 2023 AACR Annual Meeting provided updated results from the Phase I trial of GFH925. As of the data cutoff date (February 10, 2023), out of 67 evaluable NSCLC patients, 41 achieved a 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 NSCLC patients treated at 600mg BID (the recommended phase 2 dose), a more favorable 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, the multi-center trial of GFH925 and ERBITUX® (cetuximab, EGFR inhibitor) has progressed to a Phase II study in Europe, showing favorable safety and encouraging efficacy, with partial responses observed in advanced KRAS G12C-mutant patients. Led by Professor Rafael Rosell, a globally recognized expert in the field of lung cancer, the trial is ongoing in China, where Innovent is exploring the potential of IBI351(GFH925) in combination therapies for previously untreated advanced NSCLC patients with KRAS G12C mutation; two Phase Ib studies of IBI351（GFH925）in combination with cetuximab and sintilimab (TYVYT®, PD-1 inhibitor) respectively are currently underway.
The KRAS mutation, once considered an 'undruggable' target, has become a prominent focus for clinical development. IBI351 is a novel, irreversible covalent inhibitor of the KRAS G12C mutation. IBI351 monotherapy has shown favorable safety and promising activity in KRAS G12C mutated advanced NSCLC. Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, expressed anticipation for the NDA approval of this novel drug to benefit more NSCLC patients with KRAS G12C mutation soon.
GFH925 is also the first domestic KRAS G12C inhibitor to receive CDE Breakthrough Therapy Designation as monotherapy for previously treated KRAS G12C mutant CRC patients. Preliminary data from GFH925 monotherapy treating CRC at the 2023 ASCO Annual Meeting revealed favorable safety/tolerability and promising antitumor activity. As of the data cutoff date (Feb 16, 2023), analysis of 54 metastatic colorectal cancer patients included in the study showed an ORR of 42.9% (18/42), confirmed ORR of 31.0% (13/42), and DCR of 88.1% (37/42).
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