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VS-7375 (GFH375), a non-covalent dual ON/OFF KRAS G12D inhibitor, displays superior activity to ON-only #KRAS G12D inhibitors in preclini...

Gfh375 (VS-7375) NSCLC

Gfh375 (VS-7375) subgroup analysis for 2L pancreatic cancer is available and ORR is 58% @ 600 dose with 100% DCR (ASCO25) #AACR26

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Strong durable tumor regressions with the KRAS G12D ON/OFF inhibitor VS-7375 (GFH375) in combination with PRMT5 inhibition in MTAP-delete...

Oral KRAS G12D Inhibitor VS-7375 Achieves 50% Confirmed Response Rate in Second-Line Pancreatic Cancer

The oral KRAS G12D inhibitor VS-7375 showed a confirmed objective response rate of 50% (4/8) in second-line pancreatic ductal adenocarcinoma in the phase 1/2 TARGET-D 101 study. Across second-line and later patients, confirmed ORR was 41% (9/22), with two complete responses, one confirmed. Among 48 patients on 900 mg once daily monotherapy, 2% discontinued due to adverse events and grade 3 treatment-related adverse events occurred in 10%, with no clinically meaningful cumulative toxicity observed.

Verastem and GenFrog Share First Multi-Tumor Data for Oral KRAS G12D Inhibitor VS-7375 in TARGET-D 101

Verastem and GenFrog Therapeutics (Jinfang) have disclosed the first tumor-agnostic data from the phase 1/2 TARGET-D 101 trial of VS-7375, also known as GenFrog's GFH375, an oral KRAS G12D (ON/OFF) inhibitor. GenFrog retains rights in greater China while Verastem handles development and commercialization elsewhere. The data were presented on October 14.

Signal or noise? > Fifty per cent of eight: Verastem takes VS-7375 to phase 3 >> Comment below! #strategy #competitiveintelligence #marketing #competitivemarketing #pharma #healthcare #biotech #pharmaceutical

FDA Clears VS-7375 First-Line Pancreatic Cancer Trial Design With ORR as Co-Primary Endpoint

The FDA has approved the design of the TARGET-D 301 trial of VS-7375/GFH375, a KRAS G12D-selective inhibitor developed by Verastem and its partner, in first-line metastatic pancreatic cancer. Overall survival is now a secondary endpoint and confirmed ORR a co-primary endpoint, with crossover allowed to accelerate approval. The decision follows a TARGET-D 101 data update on October 14 showing a confirmed ORR of 50% in second-line pancreatic cancer monotherapy and 41% across all lines.

GFH375/VS-7375 Gains Three China Breakthrough Designations and Advances Into Phase 3 Trials

The oral KRAS G12D inhibitor GFH375/VS-7375 has been granted breakthrough therapy designation by China's CDE three times, for KRAS G12D-mutant pancreatic cancer, NSCLC, and colorectal cancer, and has entered two registrational phase 3 studies as monotherapy in pancreatic cancer and NSCLC. Partner Verastem Oncology expects to start a US FDA-aligned registrational phase 3 study of VS-7375 combinations with anti-EGFR therapy or chemotherapy in first-line pancreatic ductal adenocarcinoma by year end, co-primary endpoints PFS and ORR, OS secondary.

VS-7375 Delivers 50% Confirmed ORR in Second-Line Pancreatic Cancer

The oral KRAS G12D inhibitor VS-7375 showed confirmed objective response rates of 50% (4/8) in second-line pancreatic ductal adenocarcinoma at 900 mg once daily in the phase 1/2 TARGET-D 101 study in advanced KRAS G12D-mutant solid tumors. Across second-line and later patients, the confirmed ORR was 41% (9/22), with 2 complete responses, 1 confirmed. The data support oral KRAS G12D targeting in heavily pretreated pancreatic cancer.

Oral KRAS G12D Inhibitor GFH375/VS-7375 Advances in Chinese and Overseas Registrational Trials

GFH375/VS-7375, an oral KRAS G12D inhibitor, has received three breakthrough therapy designations in China for KRAS G12D-mutant pancreatic cancer, NSCLC and colorectal cancer, and has entered two registrational Phase III studies as monotherapy in pancreatic cancer and NSCLC. Partner Verastem Oncology plans first-line PDAC Phase III trials of multiple combination regimens with anti-EGFR therapy or chemotherapy by year-end, with PFS and ORR as dual primary endpoints and OS as secondary, under FDA-agreed protocols.

Verastem Oncology Reports New Progress on VS-7375 (GFH375) in Advanced Tumors Including Pancreatic Cancer

Verastem Oncology announced updated progress on VS-7375 (GFH375), a KRAS-targeted inhibitor, across multiple advanced solid tumors including pancreatic ductal adenocarcinoma. The announcement positions the candidate alongside broader pan-RAS inhibitors that have altered treatment of KRAS-mutant solid tumors, while targeting specific KRAS mutations. No efficacy figures were included in the announcement.

Verastem reports ‘robust’ response rate in pancreatic cancer subgroup where Rasonque struggled

VS-7375, an oral selective KRAS G12D dual ON/OFF inhibitor, produced a 50% confirmed ORR in second-line metastatic pancreatic ductal adenocarcinoma at 900 mg daily, versus 24% for Rasonque in G12D patients in the Phase 3 RASolute 302 trial. In third- and fourth-line mPDAC the confirmed ORR was 36%, with 43% confirmed ORR in NSCLC at 600 mg and 33% unconfirmed ORR in third-line colorectal cancer combined with anti-EGFR therapy. Discontinuation due to adverse events was 2% across the 295-patient TARGET-D 101 trial, and Verastem will start a Phase 3 first-line mPDAC trial by year-end.

Verastem cancer drug shows early promise in small study

Verastem's experimental KRAS G12D inhibitor VS-7375 shrank tumors in a small Phase 1/2 study, producing objective response rates of 36% to 50% in metastatic pancreatic ductal adenocarcinoma, 33% in metastatic colorectal cancer and 43% in advanced non-small cell lung cancer. Results met or exceeded analyst expectations, sending shares up 18% and prompting plans for three late-stage trials. The drug binds both the on and off states of the mutation, a design that may hold back tumor growth more completely than rivals targeting only one state.