Verastem, Inc. 8-K

What Happened
Verastem, Inc. (VSTM) announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a RP2D cohort in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) and reported dosing the first patient in the TARGET‑D 201 Phase 2 registration-directed trial. The RAMP 205 update (press release dated June 17, 2026; data cutoff June 5, 2026) covers 29 patients treated at the RP2D with avutometinib plus defactinib combined with gemcitabine and nab‑paclitaxel. The TARGET‑D 201 announcement (June 16, 2026) confirms the first patient has been dosed with VS‑7375, a KRAS G12D inhibitor, in a Phase 2 study.

Key Details

• RAMP 205 RP2D cohort: 29 patients treated; median follow-up 9.8 months (data cutoff 6/5/2026).
• Efficacy metrics at RP2D: 6‑month overall survival 86%; 6‑month progression‑free survival 68%; confirmed objective response rate (ORR) 52%; 83% of patients had tumor shrinkage. Nine patients remain on treatment.
• Dosing regimen at RP2D: avutometinib 2.4 mg twice weekly; defactinib 200 mg twice daily (3 weeks on, 1 week off); gemcitabine 800 mg/m2 + nab‑paclitaxel 125 mg/m2 on Days 1, 8, 15 of 28‑day cycles.
• Safety: adverse events consistent with prior reports; no new safety signals observed.
• TARGET‑D 201: first patient dosed (6/16/2026); Phase 2 open‑label trial of VS‑7375 900 mg daily as monotherapy and with full‑dose cetuximab in second‑line KRAS G12D‑mutated mPDAC.

Why It Matters
These results show early clinical activity for Verastem’s combination regimen in first‑line mPDAC and report no new safety issues, which supports continued development. The start of the registration‑directed TARGET‑D 201 trial for VS‑7375 marks advancement of a targeted KRAS G12D program into a Phase 2 registration‑directed setting. For investors, the updates are relevant to Verastem’s clinical progress and pipeline momentum, but they represent early‑phase data from small cohorts rather than late‑stage or commercial outcomes.