|December 5, 2016|
|Verastem Presents Phase 2 DYNAMO® Clinical Data at ASH 2016 Annual Meeting|
Duvelisib Treatment Results in a 46% ORR in Patients with Double Refractory Indolent Non-Hodgkin Lymphoma
Results from the study were presented by Dr.
The DYNAMO study included 129 evaluable patients with double refractory iNHL (median 3 prior anticancer regimens, range 1-18). The overall response rate (ORR) was 46% as determined by independent review committee (IRC; p=0.0001; 95% CI 0.37-0.55). Among disease subgroups, the ORR was 41% in follicular lymphoma (n=83), 68% in small lymphocytic lymphoma (n=28), and 33% in marginal zone lymphoma (n=18). Median duration of response (DOR) among all patients was 9.9 months. Notably, 83% of patients had reductions in the size of their target lymph nodes per IRC.
Duvelisib was generally well tolerated, with an expected and manageable safety profile with appropriate risk mitigation. The most common Grade ≥3 adverse events (occurring in ≥10% of patients) included neutropenia (28%), infection (18%), diarrhea (15%), thrombocytopenia (13%) and anemia (12%).
Dr. Flinn commented, “These results from the DYNAMO study presented at ASH this year clearly show that duvelisib is clinically active with benefit observed across a variety of disease subtypes. It is important to recognize how heavily pre-treated the DYNAMO patients were, being refractory to both rituximab and chemotherapy. This patient population needs more treatment options.”
“We are very encouraged by these results,” said
A copy of the DYNAMO oral presentation is available here.
The following is a summary of other presentations at ASH 2016:
Title: Preliminary results in first-line treatment of follicular
lymphoma with the oral dual PI3K-delta,gamma inhibitor, duvelisib, in
combination with rituximab or obinutuzumab
The poster can be viewed here.
Title: Inhibition of FAK Exerts Anti-Leukemic Activity and
Potentiates ABT-199-Induced Apoptosis in AML
The poster can be viewed here.
More About the Phase 2 DYNAMO® Study
The DYNAMO® study is a Phase 2, single-arm study which evaluated the efficacy and safety of duvelisib (25 mg twice daily) as a monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study was overall response rate as assessed by an independent review committee.
About the Tumor Microenvironment
The tumor microenvironment encompasses various cellular populations and extracellular matrices within the tumor or cancer niche that support cancer cell survival. This includes immunosuppressive cell populations such as regulatory T cells, myeloid-derived suppressor cells, M2 tumor-associated macrophages, as well as tumor-associated fibroblasts and extracellular matrix proteins which can hamper the entry and therapeutic benefit of cytotoxic immune cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s compounds duvelisib and defactinib target the tumor microenvironment as a mechanism of action to potentially improve a patient’s response to therapy.
Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B cells and T cells. PI3K signaling may lead to the proliferation of malignant B cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO®, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)4, and DYNAMO®, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) that achieved its primary endpoint of overall response rate upon topline analysis of efficacy data5. Duvelisib is also being evaluated for the treatment of hematologic malignancies through investigator-sponsored studies, including T cell lymphoma.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
Defactinib (VS-6063) is an investigational inhibitor of Focal Adhesion
Kinase (FAK), a non-receptor tyrosine kinase encoded by the PTK-2 gene
that mediates oncogenic signaling in response to cellular adhesion and
growth factors.7 Based on the multi-faceted roles of FAK,
defactinib is used to treat cancer through modulation of the tumor
microenvironment, enhancement of anti-tumor immunity, and reduction of
cancer stem cells.8,9 Defactinib is currently being evaluated
in three separate clinical collaborations in combination with
immunotherapeutic agents for the treatment of several different cancer
types including pancreatic, ovarian, non-small cell lung cancer, and
mesothelioma. These studies are combination clinical trials with
pembrolizumab and avelumab from
This press release includes forward-looking statements about Verastem’s
strategy, future plans and prospects, including statements regarding
results of the Phase 2 DYNAMO® study, and Verastem’s PI3K/mTOR and FAK
programs generally, the structure of our planned and pending clinical
trials and the timeline and indications for clinical development,
including reporting top-line data, and regulatory submissions and, our
rights to develop or commercialize our product candidates. 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 expected, including for the
Phase 3 DUO study; that enrollment of clinical trials may take longer
than expected; that our product candidates will cause unexpected safety
events or result in an unmanageable safety profile as compared to their
level of efficacy; that duvelisib will be ineffective at treating
patients with lymphoid malignancies; that
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models. Chem
Biol 2013; 20:1-11.
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