VS-7375
Start here
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.
Excerpted from mp.weixin.qq.com
Coverage timeline
Follow the coverage to see the different angles.
- mp.weixin.qq.comOral 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.
- mp.weixin.qq.comVerastem 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.
- mp.weixin.qq.comFDA 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.
- mp.weixin.qq.comGFH375/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.
- mp.weixin.qq.comOral 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.
- mp.weixin.qq.comVS-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.
- biospace.comPickVerastem 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.
- biopharmadive.comVerastem 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.
- mp.weixin.qq.comVerastem 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.
- x.comWas this slide in
Heat trend for this story
Heat now 0·Peak in the comparable set 10 (Oct 16 22:00)·Change over 24h in the comparable set -50%·Participants now 1
Participants counted above, heat below. The trend compares only the participants observed in full throughout, so its set can be smaller than the heat figure itself. Move the pointer or click the chart for an hour's reading; the left and right arrow keys work too.