GENFLEET-B (02595.HK): Phase II Data of GFH375 in Treated NSCLC Presented at WCLC, Confirmed ORR 52.1%
- Of 71 patients with at least one post-treatment assessment in the Phase II trial, the objective response rate was 59.2% and the disease control rate was 93%.
- Patients who had not previously received taxanes reached a median progression-free survival of 9.6 months, and the 12-month overall survival rate for all patients was 77%.
- As at 4 September 2026, 75 patients had received oral treatment at 600 mg once daily, 98.7% of whom had distant metastases, with no treatment-related deaths.
NewTimeSpace (newtimespace.com) News: On 15 September 2026, GenFleet Therapeutics (Shanghai) Inc. (stock code: 02595) published a voluntary announcement that updated Phase II data of GFH375 monotherapy in previously treated KRAS G12D-mutant non-small cell lung cancer (NSCLC) were presented orally at the World Conference on Lung Cancer in Seoul on 14 September local time.
As at the data cutoff, 71 patients had completed at least one post-treatment assessment, with an objective response rate of 59.2%, a confirmed objective response rate of 52.1% and a disease control rate of 93%. Patients who had not previously received taxanes reached a median progression-free survival of 9.6 months, with a median follow-up of 11 months, and the 12-month overall survival rate for all patients was 77%, with a median follow-up of 11.2 months.
As at 4 September 2026, 75 patients with KRAS G12D-mutant NSCLC had received oral GFH375 at 600 mg once daily. Of these, 98.7% had distant metastases, including bone metastases in 37.3%, brain metastases in 16% and liver metastases in 13.3%, and 42.7% had received two or more prior lines of therapy. Median progression-free survival across all patients was 8.3 months and median overall survival was not reached.
On safety, as at 17 June 2026, most treatment-related adverse events were Grade 1 to 2, most commonly diarrhoea, vomiting and nausea. Grade 3 or above events were mainly diarrhoea and elevated ALT, with no treatment-related deaths. Patients who received an immune checkpoint inhibitor within 90 days before their first oral dose showed poorer tolerability than those with an interval of more than 90 days, with Grade 3 or above hepatotoxicity of 16.7% versus 0%.
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