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Verastem Presents Results and Updated Development Plans at Annual Research and Development Day
-Lead cancer stem cell inhibitor VS-6063 continues to show promise in the clinic-
-An additional partial response reported since
-64% stable disease or better as best clinical response to date, including five objective responses, in the ongoing combination trial of VS-6063 and paclitaxel in ovarian cancer-
“We continue to see promising clinical signals from the VS-6063
program,” said Dr.
Members of the
“It is well known that in patients undergoing cancer treatment, tumors
often become resistant to standard therapies resulting in disease
progression. We believe that cancer stem cells are an underlying cause
of this failure,” said
Research and Development Day Program Highlights:
Focal Adhesion Kinase (FAK) Inhibition
-
VS-6063
-
COMMAND (Control Of Mesothelioma with MAinteNance
Defactinib), a registration-directed, randomized,
double-blind and placebo-controlled study in patients with
malignant pleural mesothelioma
- Open in 12 countries worldwide; expect to enroll 350-400 patients
-
Addition of Japanese sites to COMMAND to pursue simultaneous
development in the US, EU,
Japan and other major regions of mesothelioma incidence - Primary endpoints include Progression Free Survival (PFS) and Overall Survival (OS), with potential to seek accelerated approval on PFS
- Interim analysis to define the primary patient population expected midyear 2015
-
Combination of VS-6063 with weekly paclitaxel in patients with
ovarian cancer
- 64% clinical best response of stable disease or better including two complete, and three partial, responses. Eight patients continue on study
- Combination therapy was generally well-tolerated with no dose limiting toxicities
- Treatment with VS-6063 resulted in decreased pFAK activity and a reduction in cancer stem cells in patient biopsies following 10 days of VS-6063 treatment
-
Mesothelioma “Window of Opportunity” study prior to surgery
- Single agent VS-6063 for 12 days in patients with malignant pleural mesothelioma eligible for surgery
-
Data to be submitted to the
International Mesothelioma Interest Group (iMIG) meeting inOctober 2014
-
Phase 2 study of VS-6063 in patients with Kras-mutated NSCLC
- Single agent VS-6063 to evaluate potential clinical activity in this late-stage patient population
- Expansion of the safety data base for a potential NDA filing for mesothelioma
- An interim analysis is expected in H2 2014
-
Additional planned studies include:
-
Ovarian cancer
-
Phase 2, placebo-controlled study of VS-6063 and weekly paclitaxel in patients with platinum-resistant ovarian cancer
-
“Window of opportunity” study in patients with ovarian cancer who are undergoing surgical resection
-
-
Triple negative breast cancer
- Phase 2, placebo-controlled study of VS-6063 added to standard of care neo-adjuvant chemotherapy, in patients with newly diagnosed triple negative breast cancer undergoing surgery
- Mesothelioma
- Phase 1, dose escalation trial of VS-5584 in combination with VS-6063 in patients with relapsed/refractory mesothelioma
-
Ovarian cancer
-
COMMAND (Control Of Mesothelioma with MAinteNance
Defactinib), a registration-directed, randomized,
double-blind and placebo-controlled study in patients with
malignant pleural mesothelioma
-
VS-4718
- A Phase 1 dose escalation trial of VS-4718 in patients with advanced cancer is ongoing and interim data are expected in H2 2014
Dual PI3K/mTOR Inhibition
-
VS-5584
- A Phase 1 dose escalation trial of VS-5584 in patients with advanced cancer is ongoing and interim data are expected in H2 2014
- Initiation of a Phase 1, dose escalation trial of VS-5584 in combination with VS-6063 in patients with relapsed/refractory mesothelioma
A replay of the webcast will be archived for 90 days following the
presentation date.
Replay webcast: http://bit.ly/1vvh3sF
Replay
Passcode: 5946305
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is an aggressive form of cancer that
occurs in the mesothelium, the thin layer of tissue that covers the
lungs. Mesothelioma is associated with exposure to asbestos in most
cases. According to the
About COMMAND
COMMAND is a registration-directed, double-blind, placebo-controlled trial of VS-6063 with PFS and OS as the primary endpoints. VS-6063 targets cancer stem cells. Cancer stem cells are an underlying cause of tumor progression and recurrence. The design of COMMAND allows the opportunity to enrich for patients with tumors low in the biomarker, merlin. Preclinical and early clinical research has demonstrated that low merlin levels may be predictive of increased effectiveness of FAK inhibitors such as VS-6063. The COMMAND study stratifies patients to evaluate the effect of VS-6063 in both the overall patient population and the subgroup of patients whose tumors are low in merlin.
COMMAND is expected to enroll approximately 350-400 patients at clinical
sites in 12 countries, including the US,
About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target
cancer stem cells through the potent inhibition of focal adhesion kinase
(FAK). Cancer stem cells are an underlying cause of tumor resistance to
chemotherapy, recurrence and ultimate disease progression. Research by
About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and
highly selective activity against class 1 PI3K enzymes and dual
inhibitory actions against mTORC1 and mTORC2. In preclinical studies,
VS-5584 has been shown to reduce the percentage of cancer stem cells and
induce tumor regression in chemotherapy-resistant models.
About
Forward-looking statements:
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including statements
regarding the development of the Company’s compounds, including VS-6063,
or defactinib, VS-4718 and VS-5584 and the Company’s FAK inhibition
program, PI3K/mTOR and diagnostics programs generally, the timeline for
clinical development and regulatory approval of the Company’s compounds,
the expected timing for the reporting of data from ongoing trials, the
structure of the Company’s planned or pending clinical trials,
additional planned studies and potential indications for clinical
development or planned studies. 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 the Company’s compounds and preliminary data from
clinical trials may not be predictive of the results or success of
ongoing or later clinical trials, including the ongoing Phase 1/1b
ovarian cancer study, that data may not be available when we expect it
to be, that enrollment of clinical trials may take longer than expected,
that the Company will be unable to successfully complete the clinical
development of its compounds, including VS-6063, VS-4718 and VS-5584,
that the development of the Company’s compounds will take longer or cost
more than planned, that the Company will be unable to start additional
studies as planned and that the Company’s compounds will not receive
regulatory approval or become commercially successful products. Other
risks and uncertainties include those identified under the heading “Risk
Factors” in the Company’s Annual Report on Form 10-K for the year ended
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com