Full Press Release Details
Verastem Oncology Announces Late-Breaking Abstract from Partner GenFleet
in China of GFH375 (VS-7375) in Advanced Non-Small Cell Lung Cancer
World Conference on Lung Cancer
GFH375 demonstrated an overall response rate
(ORR) of 68.8% in non-small cell lung cancer (NSCLC) at the
recommended Phase 2 dose of 600 mg QD
GFH375 demonstrated an ORR of 57.7% in efficacy
evaluable patients with NSCLC across all dose levels
Mini oral presentation on Sunday, September
7, 2025 from 12:00 to 1:15 pm (CEST)
BOSTON--(BUSINESS WIRE)-Aug. 13, 2025--
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK-pathway-driven
cancers, today announced positive, updated safety and efficacy data and late-breaking presentation details of partner GenFleet Therapeutics'
Phase 1/2 study in China of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, known as VS-7375 outside of China, in advanced non-small cell
lung cancer patients with a KRAS G12D mutation. The data will be presented in a mini oral presentation
at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer from September
6-9, in Barcelona, Spain.
"These data at WCLC build on the encouraging
data presented at ASCO earlier this year, where GenFleet initially reported an ORR of 42% in 12 patients with advanced non-small cell
lung cancer harboring a KRAS G12D mutation," said Dan Paterson, president and chief executive officer of Verastem Oncology. "The
significant increase in patients with advanced lung cancer demonstrating a response, 68.8% ORR at the recommended Phase 2 dose, and 57.7%
ORR across all dose levels, is impressive and continues to support the development and potential of VS-7375 in advanced lung cancer and
across other advanced KRAS G12D solid tumors."
The late-breaking abstract was issued today by
the WCLC. GenFleet reported cumulative safety data across the entire study population and preliminary efficacy data specific to patients
with advanced NSCLC from the Phase 1/2 study in China. As of the data cutoff of July 15, 2025, the median follow-up time was 4.5 (range:
1.8-12.2) months. Tumor response was observed across the dose range tested. The study population includes 142 patients, including 28
with advanced NSCLC, 85 with advanced pancreatic ductal adenocarcinoma (PDAC) and 29 with other solid tumors. Amongst the patients with
NSCLC, all had metastatic disease at baseline, 64.3% had received at least two prior lines of systemic therapies, and 96.4% had received
an anti-PD1/PD-L1 therapy.
At the recommended Phase 2 dose of 600 mg once
daily (QD), the ORR was 68.8% (11/16) (both confirmed and unconfirmed) and the disease control rate (DCR) was 93.8% (15/16). Among the
26 evaluable patients with NSCLC treated across all dose levels, the ORR was 57.7% (15/26) (both confirmed and unconfirmed) and the DCR
Across all cancer types and dose levels evaluated,
the most common treatment-related adverse events (TRAEs) occurring in at least 20% of patients were diarrhea, vomiting, nausea, anemia,
decreased appetite, neutrophil count decreased, white blood cell count decreased, aspartate aminotransferase increased, asthenia, hypoalbuminemia,
and alanine aminotransferase increased, predominately Grade 1 or 2 in severity. TRAEs and severe adverse events (SAEs), greater than
Grade 3,occurred in 27.5% (39/142) and 7.7% (11/142) of patients, respectively. Of the 142 patients in the safety population, 11 patients
had dose reduction, and six discontinued due to TRAEs. No TRAE-related deaths were reported.
KRAS G12D represents 26% of all KRAS mutations,
making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal
(12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug
Administration (FDA) specifically targeting KRAS G12D mutations in cancer.
About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor
VS-7375 is a potential best-in-class, potent,
and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development
collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for
VS-7375 was cleared and initiated a Phase 1/2a clinical trial in June 2025. GenFleet's IND for VS-7375 (known as GFH375 in China)
was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.
About the GenFleet Therapeutics Collaboration
The collaboration with GenFleet Therapeutics
aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with
an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined
milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program
in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. These licenses
give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical
company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven
cancers. Verastem markets AVMAPKI FAKZYNJA CO-PACK in the U.S. Our pipeline is focused on novel
small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including
RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and
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