On May 16, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that five abstracts have been selected for poster presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 1-5, 2018 in Chicago (Press release, Verastem, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349503 [SID1234526720]).
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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, as well as defactinib, its oral small molecule inhibitor of Focal Adhesion Kinase (FAK). The poster presentations will highlight the latest findings from the Company’s ongoing clinical trials for duvelisib, the Phase 3 DUO study crossover extension in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), in addition to a Phase 1 study of defactinib in combination with pembrolizumab and gemcitabine in patients with relapsed/refractory pancreatic cancer.
A poster will also be presented on PRIMO, a Phase II study that Verastem Oncology has initiated to evaluate duvelisib monotherapy in peripheral T-cell lymphoma (PTCL), one of the most aggressive forms of non-Hodgkin lymphoma (NHL). The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy. This study was initiated based on promising activity observed with duvelisib monotherapy in T-cell lymphomas in the Phase I study. In addition, posters on biomarker measurements in the DUOTM and DYNAMOTM studies, as well as in a treatment naive follicular lymphoma study, will be presented.
"In the crossover extension trial of the Phase 3 DUO study, patients treated with duvelisib following confirmed disease progression on prior ofatumumab therapy exhibited a 73% overall response rate (ORR), compared to a 28% ORR with ofatumumab in the DUO study. These results were consistent with the ORR of patients originally initiated on duvelisib. This response rate was accompanied by a longer median progression-free survival (mPFS), with duvelisib-treated patients achieving 15-month mPFS, compared to 9 months when they were treated with ofatumumab," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology.
Dr. Le added, "For our lead FAK inhibitor defactinib, Dr. Andrea Wang-Gillam will describe initial results from the ongoing Phase 1 study evaluating defactinib in combination with pembrolizumab and gemcitabine in patients with advanced pancreatic cancer. In addition to defining a recommended Phase 2 dose, the combination regimen has been well tolerated with promising signs of clinical activity, including one confirmed partial response in a pancreatic cancer patient and stable disease in additional pancreatic patients."
"Data presented at this year’s ASCO (Free ASCO Whitepaper) meeting by Verastem Oncology and collaborative researchers also directly demonstrate inhibition of both PI3K-delta and PI3K-gamma in patients treated with duvelisib," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, biomarker changes observed in duvelisib-treated patients indicate targeting of malignant B-cells directly along with targeting of the supportive tumor microenvironment."
Details for the ASCO (Free ASCO Whitepaper) 2018 presentations are as follows:
Duvelisib
Title: The efficacy of duvelisib monotherapy following disease progression on ofatumumab monotherapy in patients with relapsed/refractory CLL or SLL in the DUO crossover extension study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 170
Abstract #: 7533
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT
Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 216
Abstract #: 7579
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT
Title: The PRIMO study: A phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral t-cell lymphoma (PTCL)
Lead author: Dr. Steven Horwitz, Memorial Sloan Kettering Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 222b
Abstract #: TPS7590
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT
Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study)
Lead author: Dr. David Weaver, Verastem Oncology
Session: Tumor Biology
Poster #: 161
Abstract #: 12048
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 1:15 – 4:45 p.m. CT
Defactinib
Title: Phase I study of defactinib combined with pembrolizumab and gemcitabine in patients with advanced cancer
Lead author: Dr. Andrea Wang-Gillam, Washington University School of Medicine in St. Louis
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster #: 387
Abstract #: 2561
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT
About Duvelisib
Duvelisib is a first-in-class investigational oral, 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- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Defactinib
Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase 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 and enhancement of anti-tumor immunity.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 cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov