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Also known as Avutometinib, avutometinib and sotorasib, avutometinib (VS-6766), avutometinib
Avutometinib+ Defactinib · 3 trials · 7 indications
Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)
Confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) as assessed by the blinded independent central radiology review committee (BICR)
To evaluate the efficacy of Avutometinib (VS-6766) + defactinib in endometrioid, MOC, HGSOC and solid gynecological cancer patients with RAS/BRAF/NF1 mutations on confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to RECIST 1.1) as assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| avutometinib + defactinib | EXPERIMENTAL | Avutometinib 3.2 mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle. |
| Investigator Choice of Treatment (ICT) | ACTIVE_COMPARATOR | Patients will receive one of the following therapies as determined by the Investigator: * Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle. * Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle. * Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle. * Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle. |
| Avutometinib (VS-6766) + Defactinib | EXPERIMENTAL | Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID). |
| Name | Type | Description |
|---|---|---|
| avutometinib | DRUG | Avutometinib: administered orally |
| Defactinib | DRUG | Defactinib: administered orally |
| Pegylated liposomal doxorubicin | DRUG | administered intravenously |
| Paclitaxel | DRUG | administered intravenously |
| Letrozole | DRUG | administered orally |
| Anastrozole | DRUG | administered orally |
| Avutometinib (VS-6766) + Defactinib (VS-6063) | DRUG | combination therapy |
| Avutometinib (VS-6766) + defactinib | DRUG | Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID). Treatment will be for 3 weeks, followed by a 1-week rest period, in each 4-week (28 day) cycle. |
Inclusion Criteria: Patients may be eligible for inclusion in the study if they meet the following criteria: 1. Histologically proven LGSOC (ovarian, fallopian, peritoneal) 2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test. 3. Suitable for treatment with at ...
Avutometinib is an investigational small molecule being studied for the treatment of several cancers, including low grade serous ovarian cancer, glioblastoma multiforme (GBM), endometrioid cancer, and non small cell lung cancer. It is currently in Phase 2 clinical development for these indications.
Avutometinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied both as a monotherapy and in combination with other agents, such as defactinib, for the treatment of various solid tumors.
Avutometinib is being developed by Verastem, Inc., a biopharmaceutical company. Verastem is listed on the stock exchange under the ticker symbol VSTM.
Avutometinib is currently in Phase 2 clinical trials. It has received Breakthrough Therapy designation and Orphan Drug designation from the FDA for certain indications, reflecting its potential in treating serious conditions.
Avutometinib is being evaluated in several clinical trials, including NCT04625270, a Phase 2 study in recurrent low-grade serous ovarian cancer; NCT05798507, an early Phase 1 study in glioblastoma; NCT06630260, a Phase 1 study in malignant brain tumors; and NCT07747506, a continued access study in low-grade serous ovarian cancer.
Yes, Avutometinib is also known as VS-6766. In clinical trials, it is often referred to as avutometinib (VS-6766), particularly when studied in combination with defactinib for conditions like low-grade serous ovarian cancer and glioblastoma.