VS-7375 delivers 50% ORR in second-line pancreatic cancer; Verastem also discloses CEO transition and $172.8M cash position
Summary
Strong VS-7375 efficacy data across pancreatic, lung, and colorectal cancers, a CEO transition, and a $172.8M cash position were all disclosed by Verastem on the same day it priced a $250M offering. VS-7375 also showed 75% ORR in first-line lung cancer and 86% disease control rate in 2L+ PDAC.
Updated with a Benzinga report · What changed
Updates
· Benzinga — VS-7375 achieved 75% ORR in first-line lung cancer cohort (n=8) and 86% disease control rate in 2L+ PDAC.
- Efficacy in PDAC — VS-7375 showed 36% ORR in third- and fourth-line PDAC, six-month progression-free survival of 67% and six-month overall survival of 80% in 2L+ PDAC. All 12 evaluable PDAC patients with detectable KRAS G12D ctDNA achieved at least 50% reduction, and seven achieved complete clearance of detectable KRAS G12D circulating tumor DNA.
- Dose Response — 900 mg dose produced deeper tumor reductions and higher response rates than 600 mg dose.
- Phase 3 Design — Phase 3 will compare two VS-7375 combination regimens against standard-of-care chemotherapy in first-line mPDAC: VS-7375 with anti-EGFR therapy and VS-7375 with gemcitabine/nab-paclitaxel. Company aligned with FDA on Phase 3 trial design.
- Safety — VS-7375 maintained manageable safety profile across monotherapy and combination regimens at 600 mg and 900 mg.
- Offering Terms — Offering priced 30.937 million shares at $8 each and included pre-funded warrants for 312,503 shares at $7.9999 apiece. Gross proceeds of $250 million will support clinical development, working capital, and general corporate purposes.
- Colorectal Cancer — VS-7375 at 900 mg combined with an anti-EGFR therapy produced a 33% ORR among six patients in third-line and later metastatic colorectal cancer, including one confirmed and one unconfirmed response.
All 14 details
- VS-7375 showed 36% ORR in third- and fourth-line PDAC settings.
- VS-7375 achieved six-month progression-free survival of 67% in 2L+ PDAC.
- VS-7375 achieved six-month overall survival of 80% in 2L+ PDAC.
- 900 mg dose produced deeper tumor reductions and higher response rates than 600 mg dose.
- All 12 evaluable PDAC patients with detectable KRAS G12D ctDNA achieved at least 50% reduction.
- Seven PDAC patients achieved complete clearance of detectable KRAS G12D circulating tumor DNA.
- Phase 3 will compare two VS-7375 combination regimens against standard-of-care chemotherapy in first-line mPDAC.
- Phase 3 experimental arms: VS-7375 with anti-EGFR therapy and VS-7375 with gemcitabine/nab-paclitaxel.
- VS-7375 maintained manageable safety profile across monotherapy and combination regimens at 600 mg and 900 mg.
- Offering priced 30.937 million shares at $8 each.
- Offering included pre-funded warrants for 312,503 shares at $7.9999 apiece.
- Gross proceeds of $250 million will support clinical development, working capital, and general corporate purposes.
- Company aligned with FDA on Phase 3 trial design for first-line metastatic pancreatic cancer.
- VS-7375 at 900 mg combined with an anti-EGFR therapy produced a 33% ORR among six patients in third-line and later metastatic colorectal cancer, including one confirmed and one unconfirmed response.
Key Events · Product Development and Regulatory · VSTM
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New · · Benzinga
VS-7375 Shows 36% ORR in Third- and Fourth-Line PDAC
VS-7375 showed 36% ORR in third- and fourth-line PDAC settings.
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New · · Benzinga
900 mg Dose Produces Deeper Tumor Reductions
900 mg dose produced deeper tumor reductions and higher response rates than 600 mg dose.
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New · · Benzinga
All Evaluable PDAC Patients Achieve ctDNA Reduction
All 12 evaluable PDAC patients with detectable KRAS G12D ctDNA achieved at least 50% reduction. Seven PDAC patients achieved complete clearance of detectable KRAS G12D circulating tumor DNA.
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New · · Benzinga
VS-7375 Maintains Manageable Safety Profile
VS-7375 maintained manageable safety profile across monotherapy and combination regimens at 600 mg and 900 mg.
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New · · Benzinga
Offering Priced at $8 Per Share
Offering priced 30.937 million shares at $8 each. Offering included pre-funded warrants for 312,503 shares at $7.9999 apiece. Gross proceeds of $250 million will support clinical development, working capital, and general corporate purposes.
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New · · Benzinga
VS-7375 Shows 33% ORR in Third-Line and Later Colorectal Cancer
VS-7375 at 900 mg combined with an anti-EGFR therapy produced a 33% ORR among six patients in third-line and later metastatic colorectal cancer, including one confirmed and one unconfirmed response.
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Updated · · Benzinga
VS-7375 Shows 50% ORR in 2L Pancreatic Cancer and 75% ORR in 1L Lung Cancer
At 900 mg QD monotherapy, the drug achieved a 50% confirmed ORR (4/8) in 2L PDAC and 41% (9/22) in 2L+, including two complete responses, with 67% six-month PFS and 80% six-month OS rates. VS-7375 also achieved 75% ORR in first-line lung cancer cohort (n=8) and 86% disease control rate in 2L+ PDAC.
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Updated · · Benzinga
FDA Alignment on Phase 3 First-Line Pancreatic Trial
Verastem reached FDA alignment on a three-arm Phase 3 design for VS-7375 in first-line mPDAC, with plans to open the trial by year-end 2026. Phase 3 will compare two VS-7375 combination regimens against standard-of-care chemotherapy in first-line mPDAC. Phase 3 experimental arms: VS-7375 with anti-EGFR therapy and VS-7375 with gemcitabine/nab-paclitaxel.
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CEO Transition to Michael Bailey
Daniel Paterson will retire as President and CEO effective January 1, 2027; Michael Bailey, former AVEO CEO who led FOTIVDA's launch, will succeed him.
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Preliminary Q3 Revenue More Than Doubles
Net product revenue is estimated at $23.9M-$24.1M for Q3 2026, up from $11.2M in Q3 2025; cash position of $172.8M as of September 30, 2026.
Analysis · VSTM · Life Sciences
A multi-part update from Verastem materially reshapes the investment thesis. The VS-7375 data—a 50% confirmed ORR in second-line pancreatic cancer, including two complete responses and an 80% six-month overall survival rate—positions the drug as potentially best-in-class among KRAS G12D inhibitors, a market with no approved therapies. The 75% ORR in first-line lung cancer and 86% disease control rate in 2L+ PDAC are additional efficacy results. FDA alignment on a Phase 3 first-line pancreatic trial design, with plans to open by year-end, accelerates the path to a pivotal readout. The CEO transition to Michael Bailey, a seasoned oncology executive who led AVEO through its FOTIVDA launch and LG Chem acquisition, brings commercial and development credibility. Preliminary Q3 revenue of $23.9M-$24.1M more than doubled year-over-year, and the $172.8M cash position—combined with the $250M offering priced earlier today—extends runway through the pivotal trial milestones. The termination of the ATM prospectus removes a potential overhang. This is a thesis-altering disclosure for a company whose lead asset just demonstrated compelling efficacy across three tumor types.
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At the time of this filing, VSTM was trading at $8.79 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $674.7M. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.