Genfleet Therapeutics (shanghai), Inc. Class H · HKEX:2595
Genfleet Therapeutics (shanghai), Inc. Class H — 2026 WCLC (IASLC World Conference on Lung Cancer)
13 slides from Genfleet Therapeutics (shanghai), Inc. Class H's conference presentation, Sep 11, 2026
Slide 1: Efficacy and Safety of GFH375 in Advanced KRAS G12D Mutant NSCLC Patients
Efficacy and Safety of GFH375 in Advanced KRASG12D Mutant Non-Small Cell Lung Cancer (NSCLC) Patients Ziming Li, MD, PhD Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine--Shanghai, China Shun Lu, Ziming Li, Xinghao Ai, Peng Chen, Wenxiu Yao, H
Slide 2: Disclosure
Disclosure • Received speaker fees from AstraZeneca, Roche and Pfizer. 2
Slide 3: Background
Background • GFH375 is a potent, highly selective, orally administrated KRASG12D inhibitor that targets both the “ON” (GTP-bound) and “OFF” (GDP-bound) states. • Preliminary clinical data of GFH375 had shown encouraging anti-tumor activity and good tolerability in NSCLC1, PDAC2, CRC and cholangiocar
Slide 4: Baseline Characteristics and Patient Disposition
Baseline Characteristics and Patient Disposition NSCLC at 600 mg (n=75) • 75 patients with KRASG12D mutant NSCLC were treated with GFH375 Age, median (range), years 62 (21-74) 600 mg once daily. Female, n(%) 27 (36.0) Smoking status, n(%) • The median prior lines of therapies was 1 (range: 1-4); all
Slide 5: Objective Response
Objective Response • Among the 71 patients with at least one post-treatment efficacy • Median (range) time to response: 1.4 months (1.4-8.3 months) evaluation, ORR was 59.2% (42/71), confirmed ORR was 52.1% (37/71). • Median duration of response: 8.3 months (95% CI: 6.3, NA) • Among the 9 patients w
Slide 6: PFS and OS
PFS and OS • Median PFS was 8.3 months (95% CI: 6.8, NA) with median follow-up time 11.0 months. ◦ Among taxane-naïve patients, median PFS was 9.6 months (95% CI: 6.7, NA) ◦ Among taxane-pretreated patients, median PFS was 8.1 months (95% CI: 5.5, NA) • Median OS was not reached (95% CI: 15.4 m, NA)
Slide 7: Safety in Patients with NSCLC
Safety in Patients with NSCLC • GFH375 presented a manageable safety profile in pretreated NSCLC patients. • The safety profile was consistent with prior reports1-3, without new safety signals. • Common TRAEs were gastrointestinal, hematological AEs and transaminitis; most were grade 1 or 2 and reco
Slide 8: Prior Exposure to ICIs Affected Safety and Tolerability
Prior Exposure to ICIs Affected Safety and Tolerability ICIs 28~90 days* ICIs >90 days Adverse events, n(%) (n=48) (n=27) Patients receiving anti-PD1/PD-L1 therapy TRAEs within 90 days before first dosing of GFH375 All grades 48 (100) 27 (100) Grade ≥3 25 (52.1) 6 (22.2) showed poorer safety and tol
Slide 9: Cooccurring Genetic Alterations in Tissue and ctDNA
Cooccurring Genetic Alterations in Tissue and ctDNA • Eligibility based on local tissue/ctDNA results; centrally tested tissue (archival or screening biopsy) and ctDNA samples (blood collected at screening or C1D1). • Central testing of baseline tissue samples were available for 58 patients and ctDN
Slide 10: Genetic Alterations in ctDNA vs. PFS
Genetic Alterations in ctDNA vs. PFS • Patients with detectable KRASG12D, TP53, STK11, KEAP1 or CDKN2A alterations presented shorter PFS. Median PFS (95% Median PFS (95% N N CI), months CI), months KRASG12D STK11/KEAP1/TP53/ 38 Not reached (8.3, undetectable 30 8.3 (8.2, NA) CDKN2A nonaltered NA) KR
Slide 11: Conclusion
Conclusion • GFH375 monotherapy presented encouraging anti-tumor activity in previously treated KRASG12D mutant NSCLC: 52.1% confirmed ORR in NSCLC patients treated at 600 mg QD 8.3 months of median PFS among all patients and 9.6 months among taxane-naïve patients Median OS not reached with 77
Slide 12: Acknowledgements
Acknowledgements • Patients who participated in this trial and their families • Clinical investigators and research staff conducting this trial • Genfleet Therapeutics (Shanghai) Inc., the sponsor of this study • All authors contributed to and approved this presentation 12
Slide 13: Thank You
wclc.iaslc.org CO@eOOO #WCLC26 ~o— ‘Thank Youe Science Without Boundaries: Uniting the World Against Thoracic Cancer
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