According to the Zhitong Finance App, Jingfang Pharmaceutical-B (02595) issued an announcement. Updated data from the Phase II trial of GFH375 single-agent treatment of KRASG12D mutant non-small cell lung cancer appeared in the oral report at the World Lung Cancer Conference (WCLC) held in Seoul this year on September 14, local time.
The report showed excellent efficacy of gfH375 in patients with nCSLC at a dose level of 600 mg qd. Nearly 100% of the enrolled patients had distant metastases, and more than 40% had received two or more treatments: as of the data cutoff date, 71 patients had completed at least one post-treatment evaluation, and the objective response rate (ORR) was 59.2%, the confirmed objective response rate (CoRR) was 52.1%, and the disease control rate (DCR) was 93%. Furthermore, the median progression-free survival (MPFs) of patients not previously treated with yew drugs reached 9.6 months (median follow-up time of 11 months), and the 12-month overall survival rate (12-monthosrate) of all patients was 77% (median follow-up time of 11.2 months).
Dr. Wang Yu, Chief Medical Officer of Jingfang, said, “This is the second time that GFH375 clinical data for NSCLC has been selected for WCLC, showing excellent efficacy in treating NSCLC in a larger population sample. Based on phase I/II data, GFH375 was the first in China to obtain breakthrough therapy certification (BTD) for treating KRASG12D mutant NSCLC, and entered the world's first phase III study ('Kirin-Fei 01') for treating NSCLC with oral KRASG12D inhibitors this year. Jingfang has a RAS therapy matrix with multiple targets, multiple molecular types, and multiple clinical protocols. The GFH375 NSCLC treatment plan also includes monotherapy and first-line combination therapy. We are confident of advancing the 'Kirin-Fly 01' research and look forward to continued positive developments in many treatments with this product.”
As of September 4, 2026, a total of 75 patients with KrasG12D mutant nsCLC received 600 mgqd oral GFH375 treatment. Of these, 98.7% had distant metastases, including bone metastases (37.3%), brain metastases (16%), and liver metastases (13.3%). All patients received platinum-containing chemotherapy and immune checkpoint inhibitors before enrolling (90.7% had received both treatments simultaneously); 42.7% of patients had received two or more lines of treatment before enrolling; 38.7% of patients had previously received yew drugs (including docetaxel), and 64% of patients were treated with immune checkpoint inhibitors (ICI) within 90 days before the first oral administration of GFH375 after enrollment. The mPFs for all patients were 8.3 months, and those who had previously been treated with yew drugs were 8.1 months, and the median overall survival (MoS) was not achieved.
As of June 17, 2026, 75 patients showed controlled safety/tolerability after receiving GFH375 monotherapy. Most treatment-related adverse events (TREs) were grade 1-2. The most common TREs include diarrhea, vomiting, nausea, etc., and most recovered after supportive treatment; grade 3 and above TREs were mainly diarrhea and elevated ALT. Overall, TREs were manageable, and there were no TREs leading to death; compared with previously reported safety data on GFH375 single drug treatment, there were no new safety signals. Research data suggests that if patients receive ICI (PD-1/PD-L1 monoclonal antibody) treatment 90 days before the first oral administration of GFH375, their safety/tolerability is less than that of patients with an interval of more than 90 days between the two treatments, particularly higher incidence of TREs such as grade 3 or higher hepatotoxicity (16.7% vs. 0%).