Novartis’ Jakavi Phase 3 trial is first of its kind to hit main goal in steroid-refractory acute graft-versus-host disease
pharmafile | April 23, 2020 | News story | Research and Development | Jakavi, Novartis, pharrma
Novartis has revealed impactful new Phase 3 data for its therapy Jakavi (ruxolitinib) in the treatment of patients with steroid-refractory acute graft-versus-host disease (GvHD).
The positive data were published in The New England Journal of Medicine and mark the first time a Phase 3 trial in GvHD hit its primary endpoint. They revealed that patients treated with Novartis’ oral JAK1 and 2 tyrosine kinase inhibitor achieved an overall response rate of 62% compared to 39% with best available therapy (BAT) after 28 days of treatment, meeting the study’s main goal.
The therapy also met its secondary endpoint, with Jakavi patients maintaining a durable overall response rate of 40% compared to 22% with BAT at eight weeks, while the drug also showed a longer median failure-free survival rate of five months compared to one month with BAT.
“Patients with acute graft-versus-host disease face life-threatening challenges with limited treatment options, particularly for the nearly half of individuals who do not respond to initial steroid therapy,” remarked Robert Zeiser at the University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation in Germany. “These new data from REACH2 showing superiority of Jakavi over current standard-of-care therapies add to a growing body of evidence on how targeting the JAK pathway can be an effective strategy in this difficult-to-treat condition.”
Novartis revealed that full data from the study would be presented at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in Madrid from the 30 August to 2 September. Further Phase 3 results for the drug in steroid-refractory chronic GvHD patients are expected to be released in the second half of 2020.
Matt Fellows
Related Content
Novartis receives SMC approval for early breast cancer treatment
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval …
Novartis candidate for Sjögren’s disease presents positive results
Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 …
First malaria medicine for infants under 4.5kg receives approval
Coartem (artemether-lumefantrine) Baby, or Riamet, has been approved by Swissmedic as the first malaria medicine …
