Rusfertide shows strong results in phase 3 Polycythemia Vera study

Takeda Pharmaceutical Company Limited (TSE:4502) and Protagonist Therapeutics announced positive topline results from the Phase 3 VERIFY study of rusfertide in patients with polycythemia vera (PV) at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study met its primary endpoint, demonstrating that 76.9% of patients treated with rusfertide plus standard care achieved a clinical response, compared to only 32.9% in the placebo group (p<0.0001). Rusfertide also achieved statistically significant improvements in key secondary endpoints, including a near three-fold reduction in phlebotomy requirements and a four-fold improvement in hematocrit control. The mean number of phlebotomies was reduced to 0.5 per patient for rusfertide, compared to 1.8 with placebo. 62.6% of patients on rusfertide maintained hematocrit levels below 45%, versus only 14.4% on placebo (p<0.0001). Rusfertide was generally well-tolerated, and Takeda plans to pursue regulatory approval.