VS-7375 Demonstrates Robust Anti-Tumor Activity Across Advanced KRAS G12D-Mutant Cancers, Highlighted by 50% Confirmed ORR in 2L Pancreatic Ductal Adenocarcinoma and Two Complete Responses in 2L+ Disease (One Confirmed)

Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology

“Patients with KRAS G12D-driven cancers deserve an effective, highly targeted therapy suitable for long-term treatment. Today’s first multi-tumor clinical dataset for VS-7375 demonstrates compelling and robust responses across KRAS G12D-mutated cancers, marking an important development milestone and reinforcing our conviction that VS-7375 has the potential to become both a best-in-class therapy and the first therapy used for these patients”

Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology

“The PDAC data provide the strongest evidence to date supporting 900 mg monotherapy as our go-forward dose. At this dose, among all 22 patients, no tumor target lesions grew, responses were deep, two patients achieved a complete response, and most of the patients remain on therapy. Our single-agent confirmed response rates in PDAC in 2L as well as 3-4L are among the highest reported to date with any RAS inhibitor, further strengthening our confidence as we advance VS-7375 into a first-line Phase 3 trial in metastatic PDAC that we plan to open by the end of 2026. We believe the emerging antitumor activity in non-small cell lung and colorectal cancers, together with the favorable tolerability profile that allows for multiple combinations, also supports the broader development opportunity, both as monotherapy and in combination in the frontline setting, for VS-7375.”

Manuel Hidalgo, M.D., Ph.D., director of the Gastrointestinal Cancer Center at NYU Langone Health and professor of medicine at NYU Grossman School of Medicine

“The clinical activity observed with VS-7375 is complemented by striking molecular responses in patients with pancreatic cancer, including deep reductions in KRAS G12D variant allele frequency and ctDNA clearance in more than half of the evaluable patients. These molecular data provide additional evidence of the meaningful biological activity of VS-7375. Equally important, its tolerability profile provides a promising foundation for evaluation of VS-7375 in combination regimens and earlier treatment settings.”

Daniel Paterson, president and chief executive officer at Verastem Oncology

“We designed our development strategy for VS-7375 around the hypothesis that deep and sustained inhibition of KRAS G12D could translate into meaningful clinical activity while maintaining the tolerability needed for long-term use and combination therapy. The PK and biomarker data support the target coverage and antitumor activity observed to date, which bolster our belief of the role VS-7375 will have in pancreatic cancer and other KRAS G12D-driven cancers and its potential to improve upon existing standard-of-care and RAS therapies.”