Avutometinib
Small molecule targets MAP2K1, MAP2K2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed borderline ovarian serous tumor 1 milestone | |||||
| Filed | US (FDA) | — | borderline ovarian serous tumor | 2024-10-31 | “Announced the initiation of a rolling New Drug Application (NDA) submission seeking accelerated approval of the combination of avutometinib and defactinib for adult patients...” verastem.com ↗ “Completed rolling NDA submission for avutometinib and defactinib combination in recurrent KRAS mutant low-grade serous ovarian cancer in October 2024” verastem.com ↗ “today announced that the Company has completed its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” verastem.com ↗ “Verastem has initiated a rolling NDA submission for avutometinib and defactinib combination in adults with recurrent LGSOC” verastem.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | — | 2025-05-08 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05798507 | Jul 2023 → Dec 2026 expected | glioblastoma | Emory University | Active not recruiting | No outcome recorded |
| Phase 16 trials · 1 met primary | ||||||
| Phase 1 | NCT07318324 | May 2026 → Aug 2028 expected | endometrial cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06104488 | Oct 2023 → Oct 2029 expected | carcinoma, low grade glioma, neuroblastoma, neurofibromatosis type 1 +4 | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03681483 | Oct 2018 → Jul 2024 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03875820 | Dec 2017 → Apr 2023 overdue | endometrioid adenocarcinoma, malignant pancreatic neoplasm, non-small cell lung carcinoma, ovarian serous tumor | Institute of Cancer Research, United Kingdom | Active not recruiting | Met primary |
| Phase 1 | NCT02407509 | Jun 2013 → Oct 2025 | lung cancer, ovarian cancer, plasma cell myeloma | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT00773526 | Nov 2008 → Sep 2011 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07824960 | Oct 2026 → Apr 2029 expected | pancreatic ductal adenocarcinoma | University of Virginia | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06630260 | Nov 2024 → Sep 2029 expected | diffuse glioma, H3 G34 mutant, glioblastoma | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06194929 | Mar 2024 → Jan 2028 expected | cutaneous melanoma, metastatic malignant neoplasm in the brain | University of Utah | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05669482 | Mar 2023 → Aug 2026 overdue | malignant pancreatic neoplasm, metastatic malignant neoplasm | Verastem, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05608252 | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Adrienne G. Waks | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05200442 | Aug 2022 → May 2027 | colorectal adenocarcinoma | University of Chicago | Suspended | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05375994 | Aug 2022 → Jun 2026 | metastatic malignant neoplasm, non-small cell lung carcinoma | Verastem, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05074810 | Apr 2022 → Jun 2026 overdue | non-small cell lung carcinoma | Verastem, Inc. | Active not recruiting | No outcome recorded |
| Phase 212 trials · 1 met primary | ||||||
| Phase 2 | NCT07126158 | Apr 2026 → Apr 2030 expected | pancreatic adenocarcinoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06369259 | Feb 2025 → Feb 2029 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06682572 | Oct 2024 → Dec 2025 overdue | ovarian cancer, ovarian serous tumor | Verastem, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06487221 | Oct 2024 → Nov 2028 expected | diffuse gastric cancer | Ryan H. Moy, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT06495125 | Jul 2024 → Mar 2029 expected | lung adenocarcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06394804 | Apr 2024 → Apr 2027 expected | malignant ovarian serous tumor | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06007924 | Aug 2023 → Aug 2027 expected | thyroid cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05787561 | Mar 2023 → Mar 2027 expected | mesonephric neoplasm | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05512208 | Feb 2023 → Dec 2027 expected | cervical cancer, endometrioid adenocarcinoma, malignant ovarian serous tumor, mucinous ovarian cancer | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 2 | NCT04720417 | Jan 2021 → Apr 2024 | uveal melanoma | Thomas Jefferson University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04620330 | Dec 2020 → Aug 2023 | non-small cell lung carcinoma | Verastem, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04625270 | Dec 2020 → Nov 2024 overdue | ovarian serous adenocarcinoma | Verastem, Inc. | Active not recruiting | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06072781 | Mar 2024 → Oct 2028 expected | ovarian serous tumor | Verastem, Inc. | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05187169 Comparator | Dec 2021 → Apr 2022 | — | Verastem, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Verastem, Inc. | Results Verastem Oncology Announces New RAMP 201 Molecular Profiling and External Control Arm Analyses Describing Outcomes for Avutometinib Plus Defactinib in Recurrent Low-Grade Serous Ovarian Cancer to be Presented at IGCS 2026 verastem.com ↗
RAMP 201 molecular profiling showed clinically meaningful activity in KRAS wild-type recurrent LGSOC, including ORRs of 22% in patients with NRAS- or BRAF-mutated tumors and 18% in patients with KRAS/NRAS/BRAF triple wild-type tumors |
| 2026-09-28 | Verastem, Inc. | Results Verastem Oncology Announces Publication in Gynecologic Oncology of Two-Year Median Follow-Up Data from RAMP 201 Study of AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) in Recurrent Low-Grade Serous Ovarian Cancer verastem.com ↗
Across patients with KRAS wild-type and KRAS-mutated recurrent LGSOC, the combination had a median duration of response of 31.1 months, median progression free survival of 12.9 months, and a safety profile consistent with the primary analysis |
| 2026-06-17 | Verastem, Inc. | Results Verastem Oncology Announces Positive Updated Results from RAMP 205 Evaluating Avutometinib Plus Defactinib in Combination with Standard-of-Care Chemotherapy in First-Line Metastatic Pancreatic Cancer verastem.com ↗
The updated data from the RAMP 205 trial provide important clinical insights into the potential impact of combined RAF/MEK and FAK inhibition as a therapeutic option for pancreatic cancer. |
| 2026-04-10 | Verastem, Inc. | Results Verastem Oncology Announces Two-Year Median Follow-Up Data on AVMAPKI® FAKZYNJA® Combination Therapy (avutometinib capsules; defactinib tablets) in Recurrent Low-Grade Serous Ovarian Cancer at the SGO 2026 Annual Meeting on Women’s Cancers verastem.com ↗
Patients in the Phase 2 RAMP 201 clinical trial demonstrated sustained clinical benefits across multiple efficacy measures highlighting durability of response with a median follow-up of two years |
| 2026-03-17 | Verastem, Inc. | Results Verastem Oncology Announces Late Breaking and Regular Abstracts Accepted for Presentation at the AACR Annual Meeting 2026 verastem.com ↗
In mutant BRAF-driven models, the combination of the FAK inhibitor VS-4718 and the RAF/MEK clamp avutometinib, with or without the mutant BRAF inhibitor encorafenib, significantly delayed tumor onset, induced regression of established tumors and brain metastases, and prolonged overall survival. |
| 2025-12-29 | Verastem, Inc. | Results Verastem Oncology Provides Update on RAMP 203 Phase 1/2 Clinical Trial for Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer verastem.com ↗
While avutometinib plus defactinib combined well with a G12C inhibitor to drive early and sustained anti-tumor responses, next generation G12C inhibitors are establishing a new benchmark with higher response rates. |
| 2025-07-11 | Verastem, Inc. | Results Verastem Oncology Announces Publication of the Primary Results from the Phase 2 RAMP 201 Trial of Avutometinib in Combination with Defactinib in Patients with Recurrent Low-Grade Serous Ovarian Cancer in the Journal of Clinical Oncology verastem.com ↗
The data reported in the publication showed that avutometinib plus defactinib demonstrated a confirmed overall response rate (ORR) of 31% in all patients with recurrent low-grade serous ovarian cancer (LGSOC). |
| 2025-06-30 | Verastem, Inc. | Results Verastem Oncology Announces Nature Medicine Publication of the Results from the First-in-Human Phase 1 FRAME Study of Avutometinib in Combination with Defactinib in Solid Tumors, including Low-Grade Serous Ovarian Cancer verastem.com ↗
FRAME study demonstrated a 42.3% ORR and 20.1 months median PFS for all patients with low-grade serous ovarian cancer (LGSOC), regardless of KRAS mutation; for patients with KRAS-mutated LGSOC, ORR and mPFS were 58.3% and 30.8 months, respectively |
| 2025-05-23 | Chugai Pharmaceutical | Results Verastem Oncology’s Announcement Regarding AVMAPKI (Positive Updated Results from RAMP 205 Evaluating Avutometinib Plus Defactinib in Combination with Standard-of-Care Chemotherapy in Frontline Metastatic Pancreatic Ductal Adenocarcinoma) chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Verastem Oncology issued a press release on AVMAPKI TM (generic name: avutometinib) about positive updated results from RAMP 205 evaluating avutometinib plus defactinib in combination with standard-of-care chemotherapy in frontline metastatic pancreatic ductal adenocarcinoma on May 22, 2025. |
| 2025-05-22 | Verastem, Inc. | Results Verastem Oncology Announces Positive Updated Results from RAMP 205 Evaluating Avutometinib Plus Defactinib in Combination with Standard-of-Care Chemotherapy in Frontline Metastatic Pancreatic Ductal Adenocarcinoma verastem.com ↗
today announced positive updated safety and efficacy results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the front-line for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). |
| 2025-05-09 | Chugai Pharmaceutical | Regulatory Verastem Oncology’s Announcement Regarding AVMAPKI (FDA Approval for AVMAPKI FAKZYNJA Combination Therapy as the First-Ever Treatment for Adult Patients with KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer) chugai-pharm.co.jp ↗
the U.S. Food and Drug Administration (FDA) has approved for AVMAPKI TM FAKZYNJA TM CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC), who received prior systemic therapy. |
| 2025-05-08 | Verastem, Inc. | Regulatory FDA Approves the AVMAPKI™ FAKZYNJA™ Combination Therapy as the First-Ever Treatment for Adult Patients with KRAS-mutated Recurrent Low-Grade Serous Ovarian Cancer verastem.com ↗
AVMAPKI FAKZYNJA CO-PACK is the first and only FDA-approved medicine for this disease. |
| 2025-03-25 | Verastem, Inc. | Results Verastem Oncology Announces Multiple Presentations Focused on RAS/MAPK Pathway Inhibition at AACR Annual Meeting 2025 verastem.com ↗
In a patient-derived LGSOC xenograft model, an FAK inhibitor addition to avutometinib augmented tumor regression with stronger inhibition of MAPK, PI3K and YAP/TEAD signaling than either agent alone |
| 2025-01-06 | Chugai Pharmaceutical | Regulatory Verastem Oncology’s Announcement Regarding Avutometinib (FDA Acceptance and Priority Review of New Drug Application for Avutometinib (in Combination with Defactinib) for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer) chugai-pharm.co.jp ↗
The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. |
| 2024-12-30 | Verastem, Inc. | Regulatory Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer verastem.com ↗ |
| 2024-12-18 | Verastem, Inc. | Results Verastem Oncology Provides a Clinical Update for RAMP 203 Trial in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer verastem.com ↗
No dose-limiting toxicities (DLTs) have been observed in the triplet combination. |
| 2024-11-01 | Chugai Pharmaceutical | Regulatory Verastem Oncology’s Announcement Regarding Avutometinib (Completion of Rolling NDA Submission to the FDA for Avutometinib plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer) chugai-pharm.co.jp ↗
Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer |
| 2024-10-31 | Verastem, Inc. | Regulatory Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer verastem.com ↗
Verastem submitted the NDA under the FDA’s Accelerated Approval pathway and requested a Priority Review based on the combination’s potential to address significant unmet medical need among patients with recurrent LGSOC. |
| 2024-10-17 | Chugai Pharmaceutical | Results Verastem Oncology’s Announcement Regarding Avutometinib (Presentation of Updated RAMP 201 Data in Recurrent Low-Grade Serous Ovarian Cancer at the International Gynecologic Cancer Society) chugai-pharm.co.jp ↗
Verastem Oncology Presents Positive Updated RAMP 201 Data for Avutometinib and Defactinib Combination in Recurrent Low-Grade Serous Ovarian Cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting |
| 2024-10-17 | Verastem, Inc. | Results Verastem Oncology Presents Positive Updated RAMP 201 Data for Avutometinib and Defactinib Combination in Recurrent Low-Grade Serous Ovarian Cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting verastem.com ↗
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced updated data from the Phase 2 RAMP 201 (ENGOTov60/GOG3052) clinical trial evaluating the combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral, selective FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC). |
| 2024-07-29 | Verastem, Inc. | Regulatory Verastem Oncology Receives FDA Orphan Drug Designation for Avutometinib and Defactinib for the Treatment of Pancreatic Cancer verastem.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to avutometinib, a RAF/MEK clamp, in combination with defactinib, a selective FAK inhibitor, for the treatment of pancreatic cancer. |
| 2024-05-27 | Chugai Pharmaceutical | Regulatory Verastem Oncology Announces Updates on Avutometinib Development chugai-pharm.co.jp ↗
Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer |
| 2024-05-24 | Verastem, Inc. | Regulatory Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer verastem.com ↗
today announced that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) |
| 2024-05-23 | Verastem, Inc. | Results Verastem Oncology Announces Positive Initial Interim Safety and Efficacy Results from RAMP 205 Trial Evaluating Avutometinib Plus Defactinib in Combination with Gemcitabine and Nab-paclitaxel in First-Line Metastatic Pancreatic Cancer verastem.com ↗
83% (5/6) of patients achieved a confirmed partial response in cohort 1, the most mature dose level; one dose-limiting toxicity was observed, however, the dose level was subsequently cleared after additional patients were enrolled |
| 2024-03-05 | Verastem, Inc. | Regulatory Verastem Oncology Receives Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer verastem.com ↗ |
| 2024-03-05 | Verastem, Inc. | Results Verastem Oncology Announces Preclinical Presentations for New Oral G12D Inhibitor and for Avutometinib and Defactinib Combination as a Backbone of Therapy for RAS/MAPK Driven Cancers at AACR Annual Meeting 2024 verastem.com ↗
Avutometinib with FAK inhibitor combination overcomes resistance to BRAF and MEK inhibitors and to immunotherapy in patient-derived melanoma models |
| 2024-01-18 | Verastem, Inc. | Regulatory Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC) verastem.com ↗ |
| 2023-11-06 | Verastem, Inc. | Results Verastem Oncology Announces Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population verastem.com ↗
Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today results of the efficacy and safety of avutometinib and defactinib in recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy. |
| 2023-10-14 | Verastem, Inc. | Results Verastem Oncology Announces Initial Results of RAMP 203 Trial of Avutometinib and LUMAKRAS™ (sotorasib) in KRAS G12C-Mutant Non-Small Cell Lung Cancer verastem.com ↗
These initial findings, including the recommended Phase 2 dose and the encouraging preliminary efficacy and safety results, provide support for the combination, and I look forward to completing the expansion phase of the trial. |
| 2023-09-28 | Verastem, Inc. | Results Verastem Presents Avutometinib and Defactinib Combination Program Updates at the 5th Annual RAS-Targeted Drug Development Summit verastem.com ↗
The clinical presentation includes updated FRAME study efficacy data showing an overall response rate (ORR) of 42% (11 of 26) in evaluable patients with low grade serous ovarian cancer (LGSOC) (n=26). |
| 2023-05-25 | Verastem, Inc. | Results Updated Data from Part A of Verastem Oncology's RAMP 201 Trial Show an Objective Response Rate of 45% in Patients with Recurrent Low-Grade Serous Ovarian Cancer Treated with Avutometinib and Defactinib verastem.com ↗
In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate (ORR) of 45% (13/29) and tumor shrinkage in 86% (25/29) of evaluable patients. |
| 2023-01-24 | Verastem, Inc. | Results Verastem Oncology Announces Positive Data and Regulatory Update from Planned Interim Analysis of Registration-Directed Phase 2 RAMP-201 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer verastem.com ↗ |
| 2022-10-04 | Verastem, Inc. | Results Verastem Oncology Announces RAMP VS-6766 Clinical Trials and Corporate Updates verastem.com ↗
Results of Part A of RAMP 202 Trial in KRAS G12V-Mutant NSCLC Show VS-6766 ± Defactinib Did Not Meet Criteria to Continue to Expansion Phase |
| 2022-06-06 | Verastem, Inc. | Results Verastem Oncology Provides Update on RAMP 201 Study Evaluating VS-6766 ± Defactinib in Low-Grade Serous Ovarian Cancer verastem.com ↗
The analysis indicated encouraging efficacy results with confirmed responses by independent review in patients treated with VS-6766 monotherapy and patients treated with VS-6766 in combination with defactinib. |
| 2021-09-19 | Verastem, Inc. | Results Verastem Oncology Announces Updated Investigator-Sponsored Phase 1/2 FRAME Study Data of VS-6766 with Defactinib in Low-Grade Serous Ovarian Cancer Showing Encouraging Response Rates and Progression-Free Survival Presented at ESMO 2021 verastem.com ↗
Median progression-free survival (mPFS) across all patients treated with VS-6766 in combination with defactinib in the study is 23.0 months. |
| 2021-05-24 | Verastem, Inc. | Regulatory Verastem Oncology Receives Breakthrough Therapy Designation for VS-6766 with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer verastem.com ↗ |
| 2021-05-11 | Verastem, Inc. | Results Verastem Oncology Reports First Quarter 2021 Financial Results and Highlights Recent Company Progress verastem.com ↗
Updated Phase 1/2 Data in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Continues to Demonstrate Activity, Durability and a Favorable Tolerability Profile for VS-6766 + Defactinib Combination |
| 2021-03-18 | Verastem, Inc. | Results Verastem Oncology Reports Fourth Quarter and Full Year 2020 Financial Results, Clinical Updates and Guidance for Key Milestones in 2021 and 1H 2022 verastem.com ↗
In the FRAME study, additional patients with recurrent LGSOC have now responded to treatment with clinically meaningful results for patients with KRAS wild-type tumors, which represents approximately 70% of all LGSOC patients. |
| 2020-10-29 | Chugai Pharmaceutical | Results Results from the Investigator-Initiated Phase I Study of RAF/MEK Inhibitor, CKI27 Published in the Lancet Oncology Online chugai-pharm.co.jp ↗
In the subsequent basket expansion part, 7 of 26 evaluable patients (26.9%) achieved objective responses. |
| 2020-10-28 | Verastem, Inc. | Results Verastem Oncology Announces New Data Published in The Lancet Oncology Supports Potential of VS-6766 as Treatment for RAS Mutant Tumors verastem.com ↗
In this dose-escalation study, tolerability and antitumor activity were observed across various cancers with RAS/RAF/MEK pathway mutations. |
| 2020-09-16 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Updated Phase 1/2 FRAME Study Data at the 2nd Annual RAS-Targeted Drug Development Summit verastem.com ↗
Preliminary Data on VS-6766 and Defactinib Combination Continues to Show Encouraging Response Rates, Durability and a Favorable Safety Profile in KRAS Mutant Low-Grade Serous Ovarian Cancer in Investigator-Initiated Trial |
| 2020-06-22 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Preclinical Data Supporting the Combination of VS-6766 and Defactinib in Metastatic Uveal Melanoma verastem.com ↗
Data Presented at the American Association for Cancer Research 2020 Virtual Annual Meeting II Show Synergism between FAK and RAF/MEK Inhibition Supporting Clinical Evaluation of Defactinib with VS-6766 in Metastatic Uveal Melanoma |
| 2020-04-27 | Verastem, Inc. | Results Verastem Oncology Announces Preliminary Data from Investigator-initiated Study Highlighting Clinical Activity of RAF/MEK and FAK Combination in KRAS Mutant Tumors Presented at the American Association for Cancer Research 2020 Virtual Annual Meeting I verastem.com ↗
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, today announced results from the ongoing investigator-initiated Phase 1 clinical study investigating VS-6766, its RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant advanced solid tumors. |
All press releases naming this drug 59 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | avutometinib | “VS-6766/avutometinib” NCT05200442 ↗ |
| Known as | avutometinib (VS-6766) | “avutometinib (VS-6766)” NCT06072781 ↗ |
| Known as | AVUTOMETINIB POTASSIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | CH5126766 | “CH5126766” NCT03875820 ↗ |
| Known as | CH5126766-002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | CKI-27 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | R-7304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | Rg-7304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | RO-5126766 POTASSIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | RO5126766 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03681483 ↗ |
| Known as | RO5126766-002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Known as | VS-6766 | “This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been...” NCT05375994 ↗15“This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal...” NCT05669482 ↗ “Avutometinib (also known as VS-6766) is an oral drug that blocks an important signaling pathway in cancer cells known as the MAP kinase pathway.” NCT06487221 ↗ “A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer” NCT05787561 ↗ “Avutometinib (VS-6766), a RAF/MEK Clamp in Combination With Defactinib, a FAK Inhibitor” NCT06104488 ↗ “Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week” NCT05512208 ↗ “Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor)” NCT04620330 ↗ “Avutometinib (VS-6766) + Defactinib (VS-6063)” NCT07824960 ↗ “Avutometinib (VS-6766) + Defactinib (VS-6063)” NCT06682572 ↗ “avutometinib (VS-6766)” NCT04625270 ↗ |
| Known as | VS-6766 POTASSIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3264002 ↗ |
| Action | Inhibit | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL3264002 ↗2“Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL3264002 ↗ “a Dual Raf and MEK Inhibitor” NCT00773526 ↗ |
| Modality | Small molecule | “VS-6766 is a unique small molecule drug” NCT05608252 ↗ |
| Route | Oral | “Administered orally daily for 28 days” NCT00773526 ↗ |
| Target | MAP2K1 | “Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL3264002 ↗ |
| Target | MAP2K2 | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL3264002 ↗ |