GenFleet Therapeutics, a commercial-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced the Pharmaceutical Administration Bureau (ISAF) of China's Macau Special Administrative Region has approved Dupert®（fulzerasib, GFH925/IBI351）for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy.
Fulzerasib was the first China-developed KRAS G12C inhibitor that had its NDA approved with Priority Review Designation in Aug 2024 by NMPA. Fulzerasib has also earned Class 1 recommendation in treatment for KRAS G12C-mutant NSCLC in the 2025 CSCO guidelines, offering patients a new option of targeted therapy with durable efficacy and good tolerability.
According to phase II data of the registrational study among patients with KRAS G12C mutant NSCLC, fulzerasib monotherapy achieved an ORR of 49.1% and a median PFS of 9.7 months; the 12-month OS rate was 54.4%, and the 12-month DoR rate was 53.7%. The monotherapy was also granted two Breakthrough Therapy Designations for treating advanced KRAS G12C-mutant NSCLC and colorectal cancer patients.
Spearheaded by GenFleet in collaboration with top-tier European lung cancer experts, the KROCUS study of fulzerasib in combination with cetuximab also delivered impressive efficacy across all first-line NSCLC patients and particularly exceptional tumor response among brain-metastatic patients. Additionally, the regimen demonstrated better safety/tolerability over fulzerasib monotherapy in second-line and above NSCLC treatment. As a pioneering combination of a KRAS G12C inhibitor (fulzerasib) and an anti-EGFR antibody (cetuximab) in first-line lung cancer treatment, this innovative approach holds the potential to establish the next-generation SOC for first-line NSCLC therapy.
According to the data in a late-breaking abstract at the mini oral presentation of the 2025 European Lung Cancer Conference (ELCC) annual meeting, 45 of the trial participants received at least one post-treatment tumor assessment as of Jan. 14 in 2025: the ORR reached 80%; the DCR reached 100%; the mPFS was 12.5 months.
