ASH: Data released on largest clinical trial of myelofibrosis patients treated with ruxolitinib

December 12, 2014

Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

Dr Al-Ali

Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th  Annual Meeting of the American Society of Hematology (ASH)  in San Francisco.

Myelofibrosis is a life-threatening and debilitating blood cancer with limited treatment options.

The open-label multicenter JUMP study, a phase 3b, expanded-access trial for countries with no access to Jakavi outside of a clinical trial, analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary end point was assessment of safety and tolerability of Jakavi. Additional analyses included changes in spleen size and symptom scores as measured by the FACT-Lymphoma Total Score (FACT-Lym TS).

In the analysis, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis.

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“Importantly, in this large population, the safety and efficacy profile of Jakavi was consistent with previous studies and continues to support what we know about treatment with Jakavi,” said study investigator Dr Haifa Kathrin Al-Ali, University Hospital of Leipzig, Leipzig, Germany.

Jakavi is the only Janus kinase inhibitor, also known as a JAK inhibitor, approved in more than 70 countries for patients with myelofibrosis and has demonstrated durable improvements in spleen size, myelofibrosis-related symptoms, and quality-of-life measures for patients with myelofibrosis.

“The analysis also demonstrated that patients treated with Jakavi experienced a reduction in spleen size that was maintained over time and a clinically meaningful improvement in symptoms, emphasizing the critical role that Jakavi plays in the treatment of myelofibrosis, an uncommon blood cancer marked by debilitating symptoms,” Dr Al-Ali said.

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