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Verastem Presents Updated Clinical Data from VS-6063 and Paclitaxel Combination Phase 1/1b Study in Patients with Ovarian Cancer at the 2014 ASCO Annual Meeting
“These data continue to show that the combination of cancer stem
cell-targeting agent VS-6063 and paclitaxel is well tolerated, with no
unexpected toxicity or worsening of the well understood side effects of
paclitaxel, and support the further study of this combination in the
clinic,” said Dr.
“We believe that to change the way cancer is treated it will be
necessary to kill both the cancer stem cells, and the bulk tumor cells,
in order to improve patient outcomes for many types of cancer,” said
A summary of the data presented by
Poster Presentation and Discussion
Date & Time:
Poster Title: Phase 1/1b Study of the FAK Inhibitor Defactinib (VS-6063) in Combination with Weekly Paclitaxel for Advanced Ovarian Cancer
Abstract Number: 5521
Session ID: Poster Highlights Session: Gynecologic Cancer
Location: E354b & E354a
Summary: Defactinib (VS-6063) is an oral small molecule that targets cancer stem cells through the inhibition of focal adhesion kinase (FAK). FAK is a protein kinase that is critical for cancer stem cell survival. Tumor initiation by cancer stem cells requires attachment, proliferation and survival which are all mediated by FAK. Standard of care (SOC) agents such as paclitaxel have been shown in preclinical models to enrich for chemoresistant and tumor initiating cancer stem cells, while preclinical studies with VS-6063 have shown that it can selectively target cancer stem cells and attenuates the enrichment of cancer stem cells typically seen with standard of care agents. This multicenter study evaluated the safety and efficacy of the combination of VS-6063 and weekly paclitaxel in advanced ovarian cancer.
The study results demonstrated that combination therapy was generally well tolerated with no dose limiting toxicities or exacerbation of paclitaxel related toxicities observed at either dose level (200mg or 400mg BID). The recommended Phase 2 dose was determined to be VS-6063 400mg BID with weekly paclitaxel (80 mg/m2) administered on Day 1, 8 and 15 of a 28 day cycle. Interesting signs of clinical activity have been observed in this ongoing trial with nine patients remaining on study. To date, four patients have exhibited objective responses: Two complete responses and two partial responses. Treatment with VS-6063 resulted in substantial decreases in FAK expression in four of the five paired biopsies. The successful administration of VS-6063 with weekly paclitaxel may enable the utilization of this combination in other clinical settings where paclitaxel is used.
Other Poster Presentations
In addition, investigators presented posters describing the trial designs from two of Verastem’s other ongoing clinical studies: one for the registration-directed COMMAND study of VS-6063 for patients with malignant pleural mesothelioma, and the other for the Phase 2 study of VS-6063 for patients with non-small cell lung cancer.
Analyst Event and Webcast
The company hosted an analyst and investor event during
A replay of the event webcast can be accessed here
or by visiting the
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 COMMAND
COMMAND is a registration-directed, double-blind, placebo-controlled trial of VS-6063 with Progression Free Survival (PFS) and Overall Survival (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
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, and the Company’s FAK inhibition program, the timeline
for clinical development and regulatory approval of the Company’s
compounds, the expected timing for the reporting of data from ongoing
trials, and the structure of the Company’s planned or pending clinical
trials, and potential indications for clinical development. 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,
that the development of the Company’s compounds will take longer or cost
more than 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