JAKARTA-2 Reanalysis Demonstrates Activity With Fedratinib in Myelofibrosis After Ruxolitinib Failure

Ruben Mesa, MD, director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, discusses the results from a reanalysis of the phase II JAKARTA-2 study in patients with myelofibrosis (MF) who received a previous treatment of ruxolitinib (Jakafi) and failed treatment.

The JAKARTA-2 trial was conducted several years ago, looking at the investigational JAK2 inhibitor fedratinib as treatment of patients with MF after ruxolitinib failure. After ruxolitinib was approved by the FDA, however, investigators found that the criteria for ruxolitinib intolerance or resistance needed to be updated. The criteria did not fully capture the activity of fedratinib, says Mesa.

With 8 years of experience in this patient population, investigators reevaluated the criteria to include minimums of 3 months on ruxolitinib therapy, amount of spleen growth, symptoms, cytopenias, and other criteria. In the reanalysis, Mesa says just under 70 patients were evaluated for efficacy with at least 6 months of fedratinib therapy.