Novartis has reported positive data from the Phase III REACH3 clinical trial, showing that Jakavi (ruxolitinib) substantially enhanced outcomes in steroid-refractory/dependent chronic graft-versus-host disease (GvHD) patients.
An oral, JAK 1 and JAK 2 tyrosine kinases inhibitor, ruxolitinib was licensed by Novartis from Incyte for development and marketing outside the US.
A fatal disease associated with the long-term complication of stem cell transplants, chronic GvHD can impact various organs. Nearly 50% of patients develop a refractory condition to or dependence on first-line steroids.
According to the results from the REACH3 trial, Jakavi offered substantial improvements in an overall response rate (ORR) at week 24, meeting the trial’s primary goal.
In the Jakavi arm, 76.4% of subjects had a best overall response (BOR) rate at any time up to week 24 versus 60.4% of those receiving the best available therapy (BAT).
Jakavi was shown to offer statistically significant and clinically meaningful improvements in longer failure-free survival (FFS) compared with the BAT arm.
Subjects in the Jakavi arm had superior improvements in self-reported symptoms versus those in the BAT arm.
Furthermore, data from a new subgroup analysis showed that subjects receiving Jakavi experienced improved outcomes irrespective of their organs involved at the baseline.
No new safety signals linked to the drug were reported in the Phase III trial. Adverse events related to Jakavi were in line with its mechanism of action and the already known safety profile.
Incyte sought approval from the US Food and Drug Administration for ruxolitinib to be marketed as Jakafi to treat steroid-refractory chronic GvHD. The application is presently under review.
Novartis’ regulatory filings outside the US for Jakavi for acute and chronic GvHD are progressing.
Novartis oncology president Susanne Schaffert said: “These new Jakavi data underscore its potential benefits and the importance of making it available to patients at risk for an all-too-common and life-threatening complication of stem cell transplants.
“We are pleased that regulatory submissions are underway and will continue to work toward wide accessibility of this important new medicine for GvHD.”
Last month, Novartis reported positive data from two Phase III trials, which further demonstrated the use of Zolgensma for treating spinal muscular atrophy in paediatric patients.