SAR302503: Phase II data

An open-label, U.S. Phase II trial in 31 patients with intermediate-2 or high-risk PMF, PPV-MF or PET-MF showed that once-daily oral SAR302503 produced mean percent reductions on the primary endpoint of spleen volume based on MRI from baseline to the end of the third 28-day treatment cycle of 30% in the 300 mg arm, 33% in the 400 mg arm and 42% in the 500 mg arm. Median percent reductions on the endpoint were 26% in the 300 mg arm, 31% in the 400 mg arm and 38% in the 500 mg arm. Sanofi said the primary endpoint did not have a pre-specified threshold for comparison of the spleen response against baseline. On secondary endpoints, spleen responses defined as a >=35% reduction in spleen volume from baseline to the end of cycle 3 were observed in 30% of patients in the 300 mg arm (n=10), 50% in the 400 mg arm (n=10) and 64% in the 500 mg arm (n=11). ...