Celgene Corporation CELG announced an updated analysis of data from the mid-stage study on pipeline candidate, fedratinib, at the 2019 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Fedratinib is a JAK2-selective inhibitor with higher potency for JAK2 over other family members — JAK1, JAK3 and TYK2. The phase II multicenter, open label, single-arm study, JAKARTA 2, evaluated the efficacy of a once daily dose of fedratinib (400 mg starting dose) in patients, who were previously treated with Incyte’s INCY Jakafi. The primary endpoint was spleen volume response rate.
This updated analysis of fedratinib employed intent-to-treat (ITT) principles in a narrower patient population (relapsed, refractory or intolerant to Jakafi).
The proportion of patients, who exhibited a 35% or greater reduction in spleen volume at end of cycle 6, was 31%. Among these, 81% met the narrower criteria for Jakafi resistance or intolerance. In this cohort, the proportion of patients, who exhibited a 35% or greater reduction in spleen volume at end of cycle 6, was 30% consistent with the response rate observed in the ITT population.
These updated results show meaningful reductions in spleen volume and symptoms, and reinforce the potential of fedratinib in these difficult-to-treat patients, who no longer receive benefit from Jakafi.
The FDA granted Priority Review designation to the NDA for fedratinib in patients with myelofibrosis, with a target action date of Sep 3, 2019.
The candidate was added to Celgene’s pipeline with the 2018 acquisition of Impact Biomedicines, Inc.
Earlier, Celgene announced promising first clinical results evaluating iberdomide (CC-220) in combination with dexamethasone in patients with relapsed and refractory multiple myeloma from the ongoing phase 1/2 CC-220-MM-001 study during an oral presentation at the ASCO.
The results included preliminary safety and efficacy data from the ongoing multi-center, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended phase 2 dose of iberdomide in combination with dexamethasone.
The experimental treatment demonstrated favorable early safety and efficacy data in patients, who had received a median five-prior treatments, including immunomodulatory agents, proteasome inhibitors and anti-CD38 agents.
Celgene has a robust pipeline. The company is focused on the next cycle of innovation with five late-stage candidates — ozanimod, fedratinib, luspatercept, liso-cel and bb2121. It also plans to evaluate fedratinib in combination with luspatercept, which is being developed in collaboration with Acceleron Pharma Inc. XLRN.
Meanwhile, the current focus is on the company’s impending merger with Bristol-Myers Squibb Company BMY, which is slated to close in the third quarter of 2019.
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