Press release
Verastem Oncology Announces Dosing of First Patient in Yakult Honsha Co., Ltd.’s Japanese Bridging Study Evaluating COPIKTRA® (Duvelisib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
BOSTON--(BUSINESS WIRE)-- Verastem, Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and
About this update from Verastem, Inc.
[{"type":"text","content":" BOSTON--(BUSINESS WIRE)--\nVerastem, Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced that its partner Yakult Honsha Co., Ltd. (Yakult) has dosed the first patient in a Phase 1b Japanese bridging study evaluating COPIKTRA® (duvelisib) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following at least one prior therapy. COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma in the United States.\n\n\n“The start of patient dosing in Yakult’s first clinical study of COPIKTRA in Japan is another important step forward in Verastem Oncology’s strategy to expand the global potential of COPIKTRA for hematological malignancies across the globe,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “The results of this study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan, where therapies are extremely limited. We look forward to supporting Yakult through the clinical development of COPIKTRA in Japan to help rapidly advance this oral, novel therapy for patients living with CLL/SLL.”\n\n\nVerastem and Yakult entered into an exclusive licensing agreement in June 2018 for Yakult to develop and commercialize COPIKTRA for the treatment, prevention or diagnosis of all oncology indications in Japan. Yakult’s Phase 1b, multicenter, open-label study is expected to enroll approximately 10 patients with relapsed or refractory CLL/SLL after at least one prior therapy. The primary endpoint of the study is objective response rate. Secondary endpoints of the study include overall survival, progression free survival and safety. This Phase 1b study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 3 DUO study. The results of the Phase 1b bridging study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan.\n\n\nCOPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment ...