Pelabresib in combination with ruxolitinib for Janus kinase inhibitor treatment-naive patients with myelofibrosis: Results of the MANIFEST-2 randomized, double-blind, phase 3 study

Results from the MANIFEST-2 phase 3 study of pelabresib plus ruxolitinib vs placebo plus ruxolitinib in patients with treatment-naïve intermediate-1/2 or high-risk myelofibrosis demonstrated efficacy in achieving spleen volume reduction of ≥35% at week 24 in 66% of patients in the pelabresib plus ruxolitinib arm vs 35% in patients on placebo plus ruxolitinib (P<0.0001). Additionally, while not statistically significant, ≥50% reduction in total symptom score at 24 weeks was achieved by 52.3% of the pelabresib plus ruxolitinib arm compared with 46.3% of the placebo plus ruxolitinib arm, and higher hemoglobin levels were experienced by patients treated with pelabresib plus ruxolitinib.