As of data cutoff date, the overall objective response rate (ORR) was 41.1% among 61 evaluable PDAC patients (40-160 mg QD), and 43.1% among RAS inhibitor naive PDAC patients; the overall ORR was 45.5% among 11 evaluable NSCLC patients (80-160 mg QD), and 55.6% among RAS inhibitor naive NSCLC patients.
GenFleet’s overseas partner Verastem Oncology has planned to open a registrational phase III study including multiple regimens of VS-7375 in combination with anti-EGFR therapy or chemotherapy, with PFS (progression-free survival) and objective response rate (ORR) serving as dual primary endpoints and overall survival (OS) as secondary endpoint; Verastem has reached alignment with the U.S. Food and Drug Administration (FDA) on the phase 3 study design.
GFH375 was the first oral KRAS G12D inhibitor in China to have been granted BTDs for pretreated non-small cell lung cancer (NSCLC) and pancreatic cancer, and has entered two registrational phase III studies evaluating monotherapy in pretreated pancreatic cancer and NSCLC. Preliminary data from the study of GFH375 in combination with cetuximab in solid tumors will be released via an online investor call in October.
Across different dose levels (100-900 mg QD) in the early-stage clincal development, GFH375 had demonstrated encouraging antitumor activity with a manageable safety and tolerability profile in heavily pretreated patients across tumor types including pancreatic cancer and non-small cell lung cancer (NSCLC).
he presentation demonstrated encouraing efficacy of GFH375 at the 600 mg QD dose level in NSCLC patients, with nearly 100% of enrolled patients having distant metastases and over 40% having received at least two prior lines of therapy.
GenFleet Therapeutics (2595.HK) announced that GFH375 has entered a phase II study for first-line treatment of patients with advanced, KRAS G12D-mutant non-small cell lung cancer (NSCLC). The multicenter, open-label, randomized trial features three arms including GFH375 monotherapy and two combination regimens pairing GFH375 with the EGFR antibody (cetuximab) or with chemotherapy (pemetrexed).
The two combination therapies include GFH375 plus GFS202A, the world’s first cachexia-targeted bispecific antibody (GDF15/IL-6 bispecific antibody), and GFH375 plus GFH276, a Pan RAS (ON) inhibitor. GFH375/VS-7375 received China’s first Breakthrough Therapy Designation for monotherapy in KRAS G12D-mutant metastatic pancreatic cancer in February 2026, following Fast Track designation from the U.S. FDA for KRAS G12D-mutant metastatic pancreatic ductal adenocarcinoma (PDAC) granted in 2025.
The updated data of GFH375 for KRAS G12D-mutant non-small cell lung cancer (NSCLC) will be presented in an oral presentation at the IASLC 2026 World Conference on Lung Cancer (WCLC); the event will take place from September 12 to 15 in Seoul, with accepted abstracts to be released on the official WCLC website by late August.
