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Thursday, January 3, 2019

Verastem aims to continue expanding commercial traction of copiktra


Verastem highlighted the company’s recent progress and outlined strategic priorities for 2019. “2018 was a pivotal year for Verastem Oncology, as the U.S. Food and Drug Administration’s approval of COPIKTRA and other key accomplishments strongly positioned us to execute on our 2019 corporate priorities that are focused on increasing revenues, initiating additional clinical studies of COPIKTRA and advancing our pipeline,” said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. “We are pleased with the strong vote of confidence we have received in duvelisib, including validating licensing agreements in key Asian markets, recognition of our pivotal Phase 3 data in the medical journal Blood, and more. We are also entering 2019 with a strong balance sheet derived from the successful completion of multiple financing transactions, which we believe provides us with important financial strength to achieve our planned corporate objectives. We look forward to keeping the momentum going, and to sharing ongoing updates on our progress.” Verastem Oncology’s 2019 focus is to execute on business priorities aimed at increasing the company’s sales and revenues: Continuing to expand on the commercial traction of COPIKTRA in CLL/SLL and FL for appropriate patients; Expansion of the open-label, multicenter, Phase 2 clinical trial evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL. This study is expected to enroll approximately 120 patients; Initiating a confirmatory Phase 3 study evaluating duvelisib for the treatment of patients with relapsed or refractory FL after at least two prior systemic therapies. The confirmatory study is expected to start in the second half of 2019; Initiating additional investigational studies of duvelisib as a monotherapy and in combination with other anti-cancer agents, such as checkpoint inhibitors, in both hematological and solid tumor malignancies; Working with the LLS to advance the PTCL program including the expansion of the Phase 2 combination study of duvelisib and romidepsin for patients with relapsed or refractory PTCL; Additional ex-U.S. partnerships for duvelisib; Presenting and publishing additional duvelisib data; and advancing the company’s focal adhesion kinase inhibitor defactinib, which is designed to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity. 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, non-small cell lung cancer, and mesothelioma.
https://thefly.com/landingPageNews.php?id=2843453

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