BioCentury
ARTICLE | Clinical News

Jakafi: Phase III data

August 1, 2016 7:00 AM UTC

Top-line data from the open-label, crossover, international Phase III RESPONSE-2 trial in 149 PV patients who were resistant to or intolerant of hydroxyurea, who were dependent on phlebotomy for hematocrit control and who did not have enlarged spleens showed that twice-daily oral Jakafi met the primary endpoint of a greater proportion of patients who achieved hematocrit control at week 28 vs. best available therapy (62.2% vs. 18.7%, p<0.0001). Jakafi also met the secondary endpoints of a greater proportion of patients who achieved complete hematologic remission at week 28 (23% vs. 5.3%, p=0.0019) and complete resolution of PV symptoms per MPN-SAF TSS (50% vs. 7.7%, p=0.0006) vs. best available therapy. Additionally, Jakafi led to a >=50% improvement in MPN-SAF TSS in 45.3% of patients vs. 22.7% of patients receiving best available therapy. Patients received investigator’s choice of hydroxyurea, interferon, pegylated interferon, pipobroman, anagrelide, immunomodulatory agents (IMiDs) or no treatment or twice-daily oral Jakafi at a starting dose of 10 mg. The Jakafi dose could be raised or lowered based on safety and efficacy. Patients receiving best available therapy could cross over to the Jakafi arm at week 28. Data were presented at the European Hematology Association meeting in Copenhagen. ...