Clinical Read2026-10-31

VS-7375 - (TARGET-D 101)

Verastem Inc.VSTM
Indication
KRAS G12D Advanced Solid Tumors
Stage
phase1
Event
Interim Data
Details

Q2 2026: Verastem Oncology (NASDAQ: VSTM) reported $25.1 million in Q2 net product revenue for AVMAPKI/FAKZYNJA and highlighted pipeline catalysts.

AVMAPKI/FAKZYNJA (avutometinib/defactinib): In recurrent low-grade serous ovarian cancer, updated RAMP 201 Japan data presented at JSGO (data cutoff May 29, 2026) showed a 44% ORR and 94% disease control rate in 16 efficacy-evaluable patients; ORR was 71% in KRAS-mutant and 22% in KRAS wild-type tumors. In first-line metastatic PDAC, updated RAMP 205 data (June 5, 2026 cutoff) showed a 52% confirmed ORR in 29 patients with 86% overall survival and 68% progression-free survival at six months, with no new safety signals. Next catalyst: topline primary endpoint readout from the Phase 3 RAMP 301 trial is expected in mid-2027; the company is also pursuing potential LGSOC expansion in Europe and Japan.

VS-7375: First patients were dosed in all three registration-directed Phase 2 TARGET-D trials—TARGET-D 201 (2L PDAC), 202 (2L/3L NSCLC), and 203 (CRC). TARGET-D 101 completed target enrollment in PDAC and NSCLC monotherapy cohorts and CRC cetuximab combination cohorts; more than 200 patients have been treated, and 1200 mg QD was cleared with no DLTs observed. FDA granted Fast Track designation in NSCLC on June 3, 2026. Updated clinical data are expected in October 2026; Phase 2 enrollment is expected to complete by year-end 2026.

The company also signed a non-dilutive royalty financing deal with Oberland Capital for up to $75 million ($50 million at closing) and reported pro forma cash of $201.4 million including a $15 million COPIKTRA sales milestone.