China NMPA approves GenFleet's fulzerasib for lung cancer treatment

China's National Medical Products Administration (NMPA) has granted approval for GenFleet Therapeutics' drug, fulzerasib, for the treatment of advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. This approval is specifically for patients who have already undergone at least one systemic therapy.

The approval process for fulzerasib gained momentum when the NMPA assigned it priority review status last year. Fulzerasib has previously been recognized with two breakthrough therapy designations, aimed at treating advanced KRAS G12C-mutant NSCLC and colorectal cancer. The approval decision was based on results from a single-arm registrational study, which demonstrated that fulzerasib was generally well-tolerated and showed significant antitumor activity.

This pivotal study reported an objective response rate of 49.1% and a disease control rate of 90.5%. Furthermore, the median progression-free survival for patients treated with fulzerasib reached 9.7 months. This promising data supports the drug's potential effectiveness in managing advanced NSCLC.

Beyond its use as a monotherapy, fulzerasib is also being tested in combination with EGFR inhibitors. This combination approach is thought to potentially offer enhanced therapeutic effects, possibly elevating fulzerasib to a first-line treatment status. A European study that began last year is assessing this combination, with early Phase II data indicating an objective response rate of 81.8%.

Fulzerasib, developed by GenFleet Therapeutics, is an orally active inhibitor targeting the KRAS G12C mutation. In September 2021, GenFleet entered into a licensing agreement with Innovent to develop and commercialize fulzerasib in China, including Hong Kong, Macau, and Taiwan. This partnership also includes options for global development and commercialization.

Yu Wang, Chief Medical Officer of GenFleet Therapeutics, emphasized the rapid and successful development trajectory of fulzerasib. Initiated in 2018, the drug has shown promising results, particularly given the high prevalence of the G12C mutation among advanced NSCLC patients in western countries. To further explore its potential, GenFleet has launched the KROCUS study in Europe. This study is investigating a first-line therapy that combines KRAS and EGFR inhibitors. According to Wang, the KROCUS study has shown that the combination of fulzerasib and cetuximab could be as effective, if not more so, than current immunotherapy and chemotherapy combinations for specific patient populations. This positions the fulzerasib/cetuximab combination as a potentially novel standard of care for patients with G12C-mutated NSCLC.

In summary, the approval of fulzerasib by China's NMPA marks a significant milestone for GenFleet Therapeutics. The drug has shown noteworthy efficacy in treating advanced NSCLC with KRAS G12C mutations and holds promise for future applications, both as a monotherapy and in combination with other treatments. The ongoing studies and international collaborations aim to further validate and expand its use, potentially offering new hope for patients battling this challenging form of cancer.