Charles Hugh-Jones, MD, Vice President, Medical Affairs North America, Sanofi Oncology, discusses the results of a phase I/II study looking at SAR302503, an investigational oral JAK2-selective inhibitor for patients with myelofibrosis.

The trial enrolled 59 patients; 44 with primary myelofibrosis, 12 post-polycythemia vera, and 4 post-essential thrombocythemia. 86% of the patients on the trial were JAK2V617F-positive.

The trial demonstrated a durable decrease in palpable spleen size of greater than 50% and a decrease in JAK2V617F allele burden at multiple intervals throughout the trial. These benefits were demonstrated in all groups of the study, including a subgroup of patients with low baseline platelet counts.

These results have led to the design of a phase III study that is currently open for recruitment, which should finish accrual in 6-9 months. The primary outcome can be expected in early 2013.


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