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Washington University in St. Louis Initiates Clinical Study of Verastem’s VS-6063 in Combination with Merck’s Pembrolizumab and Gemcitabine in Pancreatic Cancer
This Phase 1 clinical trial is anticipated to enroll approximately 50
patients and is being conducted at the
"As recently published in Cell, preclinical studies strongly suggest that the inhibition of focal adhesion kinase combined with checkpoint inhibition may potentiate a more significant tumor immune response leading to both tumor shrinkage and durable disease control," said Dr. Wang-Gillam. “This trial is primarily designed to evaluate the safety of the combination and may also provide a greater understanding of how FAK inhibition in combination with immunotherapies could improve outcomes for patients with pancreatic cancer, one of the most deadly of all cancer types.”
This clinical study is supported by a growing body of preclinical
research suggesting that focal adhesion kinase (FAK) inhibition, when
combined with PD-1 inhibitors, increases the anti-tumor activity of
these immunotherapeutic agents. As published in the
In addition to other “cold” tumors like glioblastoma and prostate, pancreatic cancer is a tumor type in which immunotherapeutics have achieved limited clinical benefit, possibly due to the dense desmoplastic stroma and the presence of high numbers of immunosuppressive cells. Pre-clinical research has demonstrated that high stromal density prevents anti-cancer agents and T cells from entering pancreatic tumors thereby limiting efficacy. In addition, FAK inhibition has been shown to reduce stromal density and allow cytotoxic T cells to better penetrate the tumor and kill the cancer cells. Collectively, these data provide strong rationale for combining Verastem’s FAK inhibitors with checkpoint inhibitors in the clinic for pancreatic cancer.
“This combination trial marks the launch of a new clinical development
program at
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 designed to target cancer stem cells through the potent inhibition of FAK. Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for their ability to improve patient survival through the targeting of cancer stem cells, potentiation of an immune response against cancer cells and reduction in the stromal density encapsulating a tumor.
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,
VS-4718 and VS-5584, and Verastem’s FAK, PI3K/mTOR and diagnostics
programs generally, the utility of FAK inhibitors for the treatment of
cancer, 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/20160106005870/en/
Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com