Drug name: Fulzerasib
R&D Code: IBI351; GFH925
CAS: 2641747-54-6
Indication: Colorectal cancer
Company: Jinfang Pharmaceutical
Development stage: Phase 3
On April 19, 2024, Shanghai Jinfang Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial of GFH925 (KRAS G12C inhibitor) in a multicenter, open-label, randomized and controlled Phase 3 study for the treatment of patients with refractory metastatic colorectal cancer (CRC).
In 2023, the Chinese National Medicines and Drug Administration (NMPA) granted GFH925 Breakthrough Therapy Designation (BTD) for the treatment of advanced colorectal cancer that had not yet received treatment. This is the first Phase 3 trial conducted globally using a KRAS G12C inhibitor as a single agent.BTD and New Drug Application Acceptance by the NMPA were also given to GFH925 in 2023. It is currently under Priority Review status for the treatment of patients with advanced non-small cell lung cancer (NSCLC) that carries the G12C mutation.
The trial (GFH925X0301) will enroll patients with refractory metastatic colorectal cancer with a KRAS G12C mutation who have progressed or experienced disease recurrence after at least two prior therapies, or who are intolerant of the most recent therapy. The main goal was to assess how effective GFH925 was in comparison to the accepted standard of care.
ESMO Asia 2023 saw the presentation of a pooled analysis from two phase 1 studies:In colorectal cancer, the effectiveness of GFH925 monotherapy (including objective remission rate and median progression-free survival) was equivalent to other combination regimens of G12C inhibitors with anti-egfr antibodies and better than that of other single-agent KRAS G12C inhibitors.
In addition, a study of GFH925 in combination with cetuximab for the first-line treatment of advanced non-small cell lung cancer in Europe is ongoing, with enrollment completed in the phase 2 trial; an analysis of the preliminary data from this combination study has been selected for an oral presentation at the 2024 ASCO Annual Meeting.
On September 2, 2021, Cinda Biotech announced that it had entered into a licensing agreement with Jinfang Pharmaceutical for exclusive worldwide development and commercial rights to the latter's KRASG12C inhibitor, GFH925, in China (including mainland China, Hong Kong, Macau and Taiwan).
In March 2023, Jinfang Pharma received EMA approval for GFH925 in combination with cetuximab for a Phase 2/3 clinical trial in non-small cell lung cancer.
