GenFleet Therapeutics (Shanghai) (2595) 2026 World Conference on Lung Cancer presentation summary

Study and population

• GFH375 is an oral, selective KRASG12D inhibitor targeting both GTP-bound ON and GDP-bound OFF states; updated data evaluated monotherapy in previously treated advanced NSCLC.

• 75 patients received 600 mg once daily; median prior therapy lines was 1 (range 1–4), all had prior ICI and platinum, and 38.7% had prior taxane.

• 29 patients (38.7%) remained on treatment; longest follow-up was 22.1 months at the Sep. 4, 2026 data cutoff.

Efficacy

• Among 71 evaluable patients, confirmed ORR was 52.1% (37/71), unconfirmed ORR 59.2% (42/71), and DCR 93.0%; median time to response was 1.4 months.

• Median duration of response was 8.3 months; among 9 evaluable patients with brain metastases, ORR was 55.6% (5/9), with no brain lesions selected as target lesions.

• Median PFS was 8.3 months overall, 9.6 months in taxane-naïve patients and 8.1 months in taxane-pretreated patients.

• Median OS was not reached; 12-month OS rate was 77.0%, with median follow-up of 11.2 months.

Safety and tolerability

• Safety was characterized as manageable, with no new signals; common treatment-related events included gastrointestinal, hematological and liver enzyme events, mostly grade 1 or 2.

• TEAEs were grade 3 or higher in 56.0% and led to discontinuation in 8.0%; TRAEs were grade 3 or higher in 41.3% and led to discontinuation in 4.0%.

• TRAEs led to dose reduction in 25.3% and interruption in 37.3%; no treatment-related deaths were reported.

• Anti-PD-1/PD-L1 exposure within 90 days before GFH375 was associated with grade 3 or higher TRAEs in 52.1%, versus 22.2% when the interval exceeded 90 days; all-grade hepatotoxicity was 62.5% versus 44.4%.