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)
Verastem reported the first multi-tumor dataset for VS-7375, its oral KRAS G12D inhibitor, from the Phase 1/2 TARGET-D 101 trial, headlined by a 50% confirmed ORR in 2L pancreatic cancer and a 41% confirmed ORR in the broader 2L+ PDAC population. Responses appear durable with an 86% disease control rate, 67% six-month PFS, and 80% six-month OS in PDAC, alongside a 43% confirmed ORR in 2L+ NSCLC and a manageable safety profile with only a 2% discontinuation rate. The company has reached FDA alignment on a chemotherapy-free-inclusive three-arm Phase 3 design in first-line mPDAC, with the trial planned to open by year-end 2026 and Phase 3 CRC/NSCLC starts expected in H1 2027.
Key figures
- Drug Name
- VS-7375
- Phase Of Trial
- Phase 1/2 (TARGET-D 101); Phase 3 planned
- Orr 2l pdac
- 50% confirmed (4/8)
- Orr 3l 4l pdac
- 36% confirmed (5/14)
- Dcr 2l plus pdac
- 86%
- Orr 2l plus pdac
- 41% confirmed (9/22)
- Six month os pdac
- 80%
- Complete responses
- 2 (one confirmed)
- Orr 1l nsclc combo
- 75% (6/8)
- Six month pfs pdac
- 67%
- Orr 3l plus crc 900mg
- 33% (2/6, one confirmed)
- Ae discontinuation rate
- 2%
- Orr 2l plus nsclc 600mg
- 43% confirmed (10/23)
AI analysis
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