Positive Primary Analysis from the Phase 2 OPTIC Study of Ponatinib in Chronic Phase-Chronic Myeloid Leukemia to be Presented at the 2021 ASCO Annual Meeting. The OPTIC trial – an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ponatinib (Iclusig®) over a range of three starting doses (45mg, 30mg, 15mg) followed by dose reduction to 15mg with the aim of optimizing efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant to prior tyrosine kinase inhibitor (TKI) therapy – met its primary endpoint.
Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Company’s ongoing clinical development program for ponatinib and the Company’s chronic-phase chronic myeloid leukemia program generally, its clinical development pipeline and whether or when ponatinib or any development compounds will be approved or commercially available for use in the United States or elsewhere for chronic myeloid leukemia program generally or any other indication, its presentation plans for the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and its goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers and development and discovery operations; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.