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FIND A CLINICAL TRIAL

For many patients with difficult-to-treat cancers, the options have been few.
Verastem Oncology aims to change that by pursuing RAS pathway-targeted treatment
combinations with avutometinib (VS-6766). Find out more about our clinical
trials here.

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A STUDY OF AVUTOMETINIB (VS-6766) + ADAGRASIB IN PATIENTS WITH KRAS G12C-MUTATED
NSCLC

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 exposed to prior G12C inhibitor and experienced
progressive disease.
Primary Condition

Non-Small Cell Lung Cancer

VIEW FULL DETAILS PRINT TRIAL INFO

--------------------------------------------------------------------------------


A PHASE 1/2 STUDY OF AVUTOMETINIB (VS-6766) + SOTORASIB IN PATIENTS WITH KRAS
G12C-MUTATED NSCLC

This study will assess the safety and efficacy of avutometinib (VS-6766) in
combination with sotorasib in patients with G12C Non-Small Cell Lung Cancer
(NSCLC) in patients who have been exposed to prior G12C inhibitor and those who
have not been exposed to prior G12C inhibitor.
Primary Condition

Non-Small Cell Lung Cancer

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A STUDY OF AVUTOMETINIB (VS-6766) + DEFACTINIB WITH GEMCITABINE AND
NAB-PACLITAXEL IN PATIENTS WITH PANCREATIC CANCER

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 Adenocarcinoma (PDAC) who have been previously untreated.
Primary Condition

Pancreatic Cancer

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A STUDY OF AVUTOMETINIB (VS-6766) + DEFACTINIB IN PATIENTS WITH KRAS
G12C-MUTANT, OTHER KRAS AND BRAF MUTATED RECURRENT NON-SMALL CELL LUNG CANCER

This study will assess the safety and efficacy of avutometinib (VS-6766)
monotherapy or VS-6766 in combination with defactinib in subjects with recurrent
Non-small cell lung cancer.
Primary Condition

Non-Small Cell Lung Cancer

VIEW FULL DETAILS

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A STUDY OF AVUTOMETINIB (VS-6766) AND DEFACTINIB IN PEOPLE WITH MESONEPHRIC
GYNECOLOGIC CANCER

This study will test if avutometinib (VS-6766) in combination with Defactinib is
an effective treatment for advanced or recurrent mesonephric gynecologic cancer.
Primary Condition

Mesonephric Gynecologic Cancer

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A PHASE 2 STUDY OF AVUTOMETINIB (VS-6766) + DEFACTINIB IN PATIENTS WITH
GYNECOLOGIC CANCERS

The purpose of this research is to test the effectiveness and safety of the
study drugs ((avutometinib (VS-6766) and defactinib)), and see what effects
(good and bad) these drugs have on the patients with endometrioid cancer,
mucinous ovarian cancer, high-grade serous ovarian cancer, or cervical cancer.
Primary Condition

Endometrioid Cancer

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A STUDY OF AVUTOMETINIB (VS-6766) AND CETUXIMAB IN PATIENTS WITH ADVANCED
COLORECTAL CANCER

Doctors leading this study hope to learn about the safety of combining the study
drug avutometinib (VS-6766) with another drug called cetuximab in colorectal
cancer. This study is for individuals who have advanced colorectal cancer and
their cancer has progressed while getting previous treatment or individuals who
cannot take/tolerate previous treatments. If you choose to participate, your
time in this research will last up to 24 months.
Primary Condition

Colorectal Cancer

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A PHASE I/II STUDY OF AVUTOMETINIB (VS-6766) + ABEMACICLIB + FULVESTRANT IN
PATIENTS WITH HR+/HER2-NEGATIVE BREAST CANCER

This research is being done to evaluate the safety and effectiveness of a drug
currently known as avutometinib (VS-6766) in combination with the drugs
abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the
study drugs involved in this study are: VS-6766 Abemaciclib Fulvestrant
Primary Condition

Breast Cancer

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A STUDY OF PEMBROLIZUMAB WITH OR WITHOUT DEFACTINIB FOLLOWING CHEMOTHERAPY AS A
NEOADJUVANT AND ADJUVANT TREATMENT FOR RESECTABLE PANCREATIC DUCTAL
ADENOCARCINOMA

This study will test the effectiveness (anti-tumor activity), safety, and
ability to increase the body's immune system to fight pancreatic cancer by
combining standard chemotherapy before and after surgery, with study drug PD-1
antibody, pembrolizumab, with and without study drug, focal adhesion kinase
inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically
removable) pancreatic cancer. The purpose of this study is to evaluate if
reprograming the tumor microenvironment by targeting FAK following chemotherapy
can potentiate anti-programmed death-1 (PD-1) antibody.
Primary Condition

Pancreatic Cancer

VIEW FULL DETAILS

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A PHASE I STUDY OF AVUTOMETINIB (VS-6766) + DEFACTINIB IN PATIENTS WITH ADVANCED
SOLID TUMORS

This is a multi-centre, investigator-initiated, dose escalation, Phase I trial
of the combination of the FAK inhibitor, Defactinib (VS-6063), and the dual
RAF/MEK inhibitor, avutometinib (VS-6766) in patients with advanced solid
tumours. VS-6766 (RO5126766) is the same compound as CH5126766.
Primary Condition

Low-Grade Serous Ovarian Cancer

VIEW FULL DETAILS PRINT TRIAL INFO

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A PHASE I TRIAL OF AVUTOMETINIB (VS-6766) MONOTHERAPY AND IN COMBINATION WITH
EVEROLIMUS IN PATIENTS WITH BRAF, KRAS AND NRAS-MUTANT SOLID TUMORS

In Part I of the study avutometinib (VS-6766) will be given twice weekly or
three times per week in treatment cycles of 4 weeks to investigate a safe and
tolerable dose of the drug. Once the optimal dosing schedule is defined, the
following patients with BRAF, KRAS and/or NRAS mutations will be enrolled: 26
patients with solid tumours (Parts IIA & IIC) and 10 patients with Multiple
Myeloma (Part IIB). Up to 44 patients with solid tumours containing BRAF, KRAS
and/or NRAS mutations will take VS-6766 in combination with everolimus (Part
IID). Of these, 20 patients will comprise the Part IID dose expansion and will
all have KRAS-mutant lung cancer.
Primary Condition

Lung Cancer

VIEW FULL DETAILS PRINT TRIAL INFO

--------------------------------------------------------------------------------


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© 2021 Verastem, Inc. All Rights Reserved.




MEET FAYE SEYEDI VIDEO TRANSCRIPT

I have always loved the science. I've always liked to do work that is discovery.
It's scientific, and obviously that's interesting to me. But I can do that in a
number of different fields related to chemistry. I can be in Ag-chemicals, for
instance. The fact that, at the end of the day, you think you might have made a
difference in someone's life, in a very impactful way, that's very gratifying.


MECHANISM OF ACTION VIDEO TRANSCRIPT

RAS, which includes KRAS, NRAS, and HRAS, is the most frequently mutated
oncogene driving Because cancer has a strong dependence on the RAS pathway,
blocking any single target is insufficient because the cancer will maintain its
growth and survival through compensatory activation of signaling proteins
elsewhere in the RAS pathway or in parallel pathways. For example:

1. ERK constantly suppresses upstream RAF signaling. Phospho-ERK inhibition by
MEK-only inhibitors attenuates this suppressive signal to activate RAF kinase
and reinvigorate tumor growth. MEK-only inhibition also induces phosphorylation
and compensatory parallel pathway activation of FAK and potentially other
parallel pathway signaling nodes that can drive tumor growth. Once activated FAK
can drive compensatory signaling through pathways, such as PI3K, RhoA and YAP,
effectively by-passing RAS pathway blockade and driving tumor growth.

2. Phospho-ERK inhibition by BRAF-only inhibitors also attenuates the
suppressive signal from ERK to RAF and induces phosphorylation and compensatory
activation of FAK. Avutometinib, which was previously known as VS-6766, is a
first in class RAF/MEK clamp that blocks RAF and MEK signaling by holding ARAF,
BRAF and CRAF in inactive complexes with MEK, and is the only agent in
late-stage clinical development that blocks more than one node in the RAS
pathway. In contrast to MEK-only inhibitors, when avutometinib blocks MEK and
feedback reactivation of RAF occurs, RAF is now prevented from
re-phosphorylating MEK and reactivating the ERK pathway, leading to a more
pronounced and sustained response.

Novel combinations may be required to achieve the deepest and most durable
response in RAS- mediated cancers. avutometinib has the potential to become a
backbone of therapy by combining it with a variety of other agents targeting the
RAS pathway and parallel pathways. Preclinical data have shown a strong synergy
beween avutometinib in combination with inhibitors of other nodes of the RAS
pathway, such as EGFR, KRAS G12C, SHP2, SOS1 and ERK1/2. Synergy of avutometinib
with inhibitors of parallel pathway targets, including FAK, CDK4/6, PI3K, AKT
and mTOR has also been demonstrated. For example, the combination of
avutometinib with the FAK inhibitor, defactinib, blocks both RAF and MEK as well
as the compensatory FAK activation for more complete blockade of signaling and
tumor growth. Avutometinib has the potential to become the preferred backbone of
therapy for a variety of agents targeting the RAS pathway and parallel pathways
involved in tumor growth and metastases. With improved control over the RAS
signaling network, it is possible to develop customized treatment combinations
using avutometinib. Such combinations have the potential to significantly
broaden the range of effective treatments available to patients with RAS
pathway-driven cancers who currently have limited options.


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