Dr. Yacoub on Next Steps With Parsaclisib Plus Ruxolitinib in Myelofibrosis

Abdulraheem Yacoub, MD, an associate professor of medicine at the University of Kansas Medical Center, discusses next steps with the combination of parsaclisib and ruxolitinib (Jakafi) in myelofibrosis.

During week 1 of the 2021 AACR Annual Meeting, findings from a phase 2 trial (NCT02718300) were presented as a virtual poster. At 24 weeks, the all-daily regimen of the PI3Kδ inhibitor parsaclisib plus the JAK inhibitor ruxolitinib led to a median percentage change of –25.4% in spleen volume from baseline. The median percentage change in the Myelofibrosis Symptom Assessment Form-Total Symptom Score was –39.6% at 12 weeks.

As such, two international, phase 3 studies are open to further evaluate parsaclisib in combination with ruxolitinib, says Yacoub. The LIMBER-313 trial (NCT04551066) is randomizing patients with previously untreated myelofibrosis to the combination regimen vs ruxolitinib plus placebo, Yacoub says. The goal of the study is to determine whether the up-front use of the combination provides additional benefit to patients vs the standard of care, Yacoub says.

The LIMBER-304 trial (NCT04551053) is evaluating parsaclisib plus ruxolitinib vs ruxolitinib plus placebo in patients who achieved a suboptimal response with a stable dose of ruxolitinib, Yacoub concludes.