A second late-stage study of Incyte’s (INCY) Jakafi (ruxolitinib) in polycythemia vera (PV) failed on Wednesday, though the company says the study isn’t necessary for FDA approval.
RELIEF was a randomized, double-blind trial designed to compare symptom improvement in 110 patients with PV, comparing ruxolitinib to hydroxyurea.
The phase 3 study, testing ruxolitinib in the rare blood cancer failed to achieve statistical significance on its primary endpoint, the proportion of patients with ≥50% reduction in PV symptoms, including tiredness, itching, muscle aches and night sweats. Jakafi produced a 43.4% symptom response rate in the 110-subject trial, while patients receiving hydroxyurea demonstrated a 29.6% response rate. With a p-value of 0.139, the difference was not considered statistically significant.
Jakafi was approved for intermediate- or high-risk myelofibrosis in 2011. The company completed another phase 3 PV trial, dubbed RESPONSE, this June testing Jakafi in patients who are resistant to or intolerant of hydroxyurea. That trial met its primary endpoint, hematocrit control and at least a 35% reduction in spleen volume, and was conducted under a Special Protocol Asses. RESPONSE was an open-label randomized trial of 222 patients. Incyte submitted the supplemental NDA to the FDA in June for the addition of PV.
According to Incyte’s Chief Drug Development & Medical Officer, Richard Levy, M.D. the RELIEF trial was not required for FDA approval in PV: “RELIEF was designed to provide us with additional information regarding symptom improvement . . .The patients recruited into the RELIEF study had less advanced PV compared to those in RESPONSE, our larger pivotal Phase III study which formed the basis of the sNDA, and which met the primary endpoint of improved hematocrit control and reduced spleen size in patients with uncontrolled PV.”
Incyte will report second quarter earnings on July 31.
