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Verastem Reports Phase 2 Long-Term Follow-Up Data for Duvelisib in Patients with Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma at the 22nd Congress of the European Hematology Association
43%
68%
Duvelisib Remains Well Tolerated in Long-Term Follow Up
Oral Duvelisib in Patients with Double-Refractory FL
With 18 months of follow-up, the data continues to be consistent with
the primary analysis. Of the 83 patients with double-refractory FL
enrolled in DYNAMO (median 3 prior anticancer regimens [range 1-10]), 36
responded, which included 1 (1%) complete response (CR) and 35 (42%)
partial responses (PR), for an
The safety profile of duvelisib monotherapy remains consistent with what has been previously reported in iNHL and other advanced hematologic malignancies. In these double-refractory FL patients, the most common Grade ≥3 hematologic adverse events were neutropenia (22%), anemia (13%) and thrombocytopenia (9%). Diarrhea was the most frequently reported nonhematologic adverse event (47%; 16% Grade ≥ 3). As expected in a heavily pretreated and refractory patient population, severe infections were observed (20%). Pneumonitis and colitis remained relatively uncommon (each 5%). Treatment discontinuations attributed to severe adverse events were infrequent, suggesting that these events were generally manageable.
Oral Duvelisib in Patients with Double-Refractory SLL
Of the 28 patients with double-refractory SLL enrolled in DYNAMO (median
3 prior anticancer regimens [range 1-18]), 19 responded, all of which
were PRs, for an
In these double-refractory SLL patients, the most common Grade ≥3 hematologic adverse events were neutropenia (32%), thrombocytopenia (21%) and anemia (21%). The most frequently reported Grade ≥3 nonhematologic adverse events were pneumonia (14%), increases in alanine aminotransferase (7%) and aspartate aminotransferase (11%), and diarrhea (11%). As expected in a heavily pretreated and refractory patient population, severe infections were observed (36%). Colitis occurred in 3 (11%) SLL patients. No double-refractory SLL patients experienced pneumonitis. Treatment discontinuations attributed to the most common adverse events were infrequent, suggesting that these events were generally manageable.
“We believe that oral duvelisib has the potential to be an important new
treatment option for lymphoma patients,” commented Pier Luigi Zinzani,
MD, PhD, of the
Details for the presentations at EHA 2017 are:
Oral Presentation
Title: DYNAMO: A Phase 2 Study Demonstrating the Clinical
Activity of Duvelisib in Patients with Double-Refractory Follicular
Lymphoma
Abstract code: S777
Topic: Indolent
Non-Hodgkin lymphoma – Clinical
Session title: Follicular
lymphoma – Clinical
Location: Hall C
Date and time:
A copy of the oral presentation slides will be available here following the conclusion of the oral presentation.
E-Poster Presentation
Title: DYNAMO: The Clinical Activity of Duvelisib in Patients
with Double-Refractory Small Lymphocytic Lymphoma in a Phase 2 Study
Abstract
code: E1130
Topic: Indolent Non-Hodgkin lymphoma –
Clinical
Location: e-poster screens
Date and time:
A copy of the e-poster presentation will be available here following the conclusion of the meeting.
More About the Phase 2 DYNAMO™ Study
DYNAMO™ is a Phase 2, single-arm study, which evaluated the efficacy and
safety of duvelisib 25 mg twice daily as monotherapy in 129 iNHL
patients, including follicular lymphoma (n=83), small lymphocytic
lymphoma (n=28), and marginal zone lymphoma (n=18) whose disease has
progressed and are refractory to rituximab and to either chemotherapy or
radioimmunotherapy. The primary endpoint of the study was
About the Tumor Microenvironment
The tumor microenvironment encompasses multiple tumor and non-tumor cell populations and an extracellular matrix that support cancer cell survival. This includes immunosuppressive regulatory T-cells, myeloid-derived suppressor cells, tumor-associated macrophages, cancer-associated fibroblasts, and extracellular matrix proteins that can hamper the entry and therapeutic benefit of cytotoxic T-cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s product candidates, including duvelisib and defactinib, also target the tumor microenvironment to potentially improve response to therapy.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide
3-kinase (PI3K)-delta and PI3K-gamma, two enzymes 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 or refractory CLL,4
and DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with
refractory iNHL that achieved its primary endpoint of
About
This press release includes forward-looking statements about
References
1 Winkler 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.
2 Reif
et al. Cutting Edge: Differential roles for phosphoinositide 3 kinases,
p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J
Immunol 2004:173:2236-2240.
3 Schmid et al. Receptor
tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3K,
a single convergent point promoting tumor inflammation and progression.
Cancer Cell 2011;19:715-727.
4 www.clinicaltrials.gov,
NCT02004522
5 www.clinicaltrials.gov,
NCT01882803
6 www.clinicaltrials.gov,
NCT02783625, NCT02783625, NCT02158091
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Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com