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Verastem Oncology Announces Initial Data In First Multi-Tumor Update From Ongoing TARGET-D 101 Phase 1/2 Clinical Trial Evaluating VS-7375; Data Demonstrate Robust Clinical Activity With Favorable Safety And Tolerability Profile Across Multiple Dose Levels And Tumor Types
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VS-7375 900 mg QD monotherapy achieved a 41% confirmed ORR in the broader 2L+ pancreatic ductal adenocarcinoma (PDAC) patient population and a 36% confirmed ORR in 3-4L; responses are durable with a majority of patients ongoing >6 months and a 67% landmark 6-month PFS rate

FDA alignment reached on Phase 3 trial design in 1L mPDAC; plan to open trial by year-end

Early results in heavily pretreated 3L+ colorectal cancer (CRC) include 33% unconfirmed ORR with 900 mg QD in combination anti-EGFR therapy with no patients with target lesion increases

VS-7375 achieved 43% confirmed ORR with 600 mg QD monotherapy in 2L+ non-small cell lung cancer (NSCLC) including patients with prior taxane treatment; durable responses were observed and PFS is trending favorably; 900 mg QD dosing ongoing in Phase 2 TARGET-D 202 trial

With longer follow-up and expanded enrollment VS-7375 900 mg QD maintained a consistent tolerability profile with no evidence of cumulative toxicity and a 2% discontinuation rate due to adverse events, supporting 900 mg QD as the go-forward monotherapy dose and its combination potential

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