Novartis announces first data from REACH3 trial showing Jakavi (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD - Seite 2

No new safety signals were observed in REACH3, and adverse events (AEs) attributable to treatment were consistent with the known safety profile of Jakavi. The most common AEs in the Jakavi vs. BAT arms were anemia (29.1% vs. 12.7%), thrombocytopenia (21.2% vs. 14.6%), hypertension (15.8% vs. 12.7%) and pyrexia (15.8% vs. 9.5%). While 37.6% and 16.5% of patients required Jakavi and BAT dose modifications, respectively, the number of patients who discontinued treatment due to AEs was low (16.4% and 7%, respectively). Mortality rates were similar across treatment arms (19% vs. 16% BAT)¹. Deaths reported as primarily due to chronic GvHD were slightly higher for Jakavi.

GvHD, a common and potentially life-threatening complication that can arise after allogeneic stem cell transplants, is a reaction where the donor’s cells attack the recipient’s normal cells because it sees them as foreign². The two main types of GvHD are acute GvHD, which occurs within 100 days of transplant, and chronic GvHD, which occurs after 100 days of transplant². Around 50 percent of people experience either acute or chronic GvHD, or both, following allogeneic stem cell transplant³. Symptoms of chronic GvHD can affect the skin, gastrointestinal tract, liver, mouth, lungs and joints⁵. There is a need for additional treatment options for people who do not respond to initial steroid therapy for GvHD or are considered steroid-refractory³.

In 2019, the US Food and Drug Administration approved ruxolitinib (marketed by Incyte Corporation in the U.S. as Jakafi) for the treatment of steroid-refractory acute GvHD in adult and pediatric patients 12 years and older based on results of the single-arm Phase II REACH1 trial⁶. REACH3 (NCT03112603) is a Phase III, randomized, open-label, global multicenter study to evaluate Jakavi compared to BAT in patients with steroid-refractory or steroid-dependent chronic GvHD following allogeneic stem cell transplant⁷. Regulatory filings for steroid-refractory/dependent GvHD in Europe and other ex-US countries based on these data are planned for the first half of 2021.

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About Jakavi (ruxolitinib)
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease- related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. Jakavi is approved in over 100 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 85 countries for patients with PV, including EU countries, Switzerland, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.