Press Release
<< Back
Verastem Announces the Presentation of Clinical Data at iMig 2016
- VS-6063 generally well tolerated; early signs of tumor reduction observed -
- Results from Cohort 2 continue encouraging observations from Cohort 1 for single-agent VS-6063 in chemotherapy-naïve patients as a neoadjuvant therapy -
The primary objective from this ongoing open-label, single-center, neoadjuvant Window of Opportunity study is to evaluate tolerability, along with biomarker and tumor volume response to Verastem’s focal adhesion kinase (FAK) inhibitor VS-6063 (400mg BID) following either 12 days (Cohort 1) or 35 days (Cohort 2) of treatment in surgically-eligible patients with malignant pleural mesothelioma (MPM).
“Results from this early-stage study show that single-agent VS-6063 was generally well tolerated as a neoadjuvant therapy in chemotherapy-naïve patients,” said Dr. Bueno. “In addition to evidence of a favorable safety profile, we also observed reductions in tumor size and favorable potential immunomodulatory effects. These Cohort 2 results continue the findings from Cohort 1 for the effects of single-agent VS-6063 in surgically-eligible mesothelioma patients.”
Data analysis from Cohort 1 and Cohort 2 (n=20) showed that VS-6063 was generally well tolerated with no apparent negative impact on surgical outcome. Six of the twenty patients demonstrated an encouraging tumor reduction after brief treatment with VS-6063 (12 or 35 days). Using expression data, a positive correlation between tumor reduction and an ESTIMATE Score (Estimation of STromal and Immune cells in Malignant Tumours; Yoshihara et al., Nature Commun. 2013) were observed. Notably, increased CD8+ T-cell infiltration and significant decreases in IL-10, an immunosuppressive cytokine, were observed with VS-6063 treatment (p = 0.0186).
“These data are early but encouraging and support the growing body of
research supporting the thesis that FAK inhibition produces favorable
changes within the tumor microenvironment,” said
Details for the presentation at iMig 2016 are as follows:
Oral Presentation
Title: Phase 2 Neoadjuvant Study of VS-6063, a FAK Inhibitor, in
Subjects with Surgically Resectable Malignant Pleural Mesothelioma
Session:
Mini Symposium 10: Novel Targets – Entering in the Clinic (Track: Early
Phase Clinical Trials)
Date and time:
A copy of the oral presentation will be available following the presentation at http://bit.ly/R3M6wc
About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for patients with cancer.
About
This press release includes forward-looking statements about Verastem’s
strategy, future plans and prospects, including statements regarding the
development and activity of Verastem’s product candidates, VS-6063 and
VS-4718, and Verastem’s FAK and diagnostics programs generally, the
utility of FAK inhibitors for the treatment of cancer including in
combination with other cancer treatments, the timeline for clinical
development and regulatory approval of our product candidates, the
structure of our planned or pending clinical trials, our rights to
develop or commercialize our product candidates and our ability to
finance contemplated development activities and fund operations for a
specified period. The words “anticipate,” “appear,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,” “continue,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. Each forward-looking statement is subject to risks
and uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the preclinical testing of
Verastem’s product candidates and preliminary or interim data from
clinical trials may not be predictive of the results or success of
ongoing or later clinical trials, that data may not be available when we
expect it to be, that enrollment of clinical trials may take longer than
expected, that our product candidates will cause unexpected safety
events, that
View source version on businesswire.com: http://www.businesswire.com/news/home/20160503005500/en/
Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com
