GenFleet Therapeutics, an oncology-focused biotechnology company, has announced that Dupert (fulzerasib, GFH925/IBI351) has received approval from China’s National Medical Products Administration (NMPA).
Dupert is now authorized in China for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and have previously undergone at least one systemic therapy.
Fulzerasib, the first KRAS G12C inhibitor developed in China, had its new drug application (NDA) accepted with priority review designation in 2023.
Additionally, it has been awarded two breakthrough therapy designations (BTD) for treating advanced KRAS G12C-mutant NSCLC and colorectal cancer (CRC).
The NDA approval is supported by data from a single-arm registrational study. It assessed the efficacy and safety of fulzerasib monotherapy in KRAS G12C-mutated NSCLC patients who had either failed or were intolerant to standard treatments in China.
As of the data cut-off on 13 December 2023, the study included 116 evaluable NSCLC patients. Dupert was generally well-tolerated and showed promising antitumour activity.
The confirmed objective response rate (ORR), as assessed by the Independent Radiology Review Committee (IRRC), was 49.1%. The disease control rate (DCR) was 90.5%.
The median duration of response (DoR) was not reached, while the median progression-free survival (PFS) was 9.7 months. The median overall survival (OS) has not yet been reached.
GenFleet Therapeutics chief medical officer Yu Wang said: “Initiated in 2018, the fulzerasib’s development has been moving forward rapidly and yielded positive results. We are delighted at the approval of fulzerasib in China and thankful for the collaborative efforts of Innovent Biologics and the investigators.
“Given the high G12C prevalence among advanced NSCLC patients in western countries, GenFleet has embarked on the KROCUS study in Europe, a pioneering trial of first-line therapy integrating KRAS and EGFR inhibitors.”
In addition to its use as a monotherapy, combining KRAS and EGFR inhibitors may enhance treatment effectiveness, making Dupert a promising option for first-line therapy, GenFleet Therapeutics said.
In 2023, the biotechnology company launched a KROCUS study in Europe to explore this combination in first-line NSCLC treatment in combination with cetuximab.
In April of this year, the US Food and Drug Administration (FDA) approved GenFleet’s Phase 2 study of fulzerasib for CRC patients with G12C mutations who are resistant to other treatments.
