New anti-transplant drugs! Incyte/Novartis Jakafi (Russotinib) Therapeutic steroids difficult to treat chronic grafts anti-host disease Phase III clinical success!

24, 2020 // Novartis and partner Incyte recently announced that the evaluation of Jakafi (ruxolitinib, Russotinib) treatment of patients with moderate to severe steroid refractive or hormone-dependent chronic transplantation (GVHD) reached the main endpoint and 2 key secondary endpoints.
GVHD is a serious and common complication of allogeneic stem cell transplantation, and there is no widely recognized treatment for non-responsive patients treated with steroids.
REACH3 (NCT03112603) is a random, open-label, multi-center 3-phase study sponsored by Novartis and co-sponsored and co-financed by Incyte.
the study is evaluating the safety and efficacy of ruxolitinib and best available therapy (BAT) for patients with steroid refractive chronic GVHD. the primary endpoint of
is the total remission rate (ORR) of the first day of the 7th cycle of visits (day 168), defined as the percentage of patients that show full or partial remission.
secondary endpoints include changes in the improved Lee Chronic GVHD Symptom Scale (mLSS) score on day 1 of the 7th cycle, no failure survival rate (FFS) within 36 months, optimal total remission rate (BOR), duration of remission (DoR), total lifetime (OS), etc.
results showed that the study reached the primary endpoint: in the 24th week of treatment, the ruxolitinib group achieved a better overall remission rate (ORR) than the BAT group.
in addition, the study reached two key secondary endpoints: ruxolitinib significantly improved failure-free survival (PFS) and patient-reported symptoms (assessed by mLSS) compared to BAT.
these top-line results are based on previously reported positive data from REACH1 and REACH2 tests.
previous data show that Jakafi improved a range of efficacy indicators in patients with steroid refractive acute GVHD.
data from the REACH3 study will be presented at an upcoming major medical conference and will be submitted to the FDA for approval of Jakafi for the treatment of patients with steroid refractory or hormone-dependent GVHD. "These positive results from the REACH3 study are significant because they highlight the potential of Jakafi to provide meaningful treatment options, not only for acute GVHD patients, but also for patients with chronic forms of GVHD," said Dr. Peter Langmuir, Vice President of the incyte Oncology Targeting Group at
.
based on the results of this Phase III study, we will continue to present these data to the FDA as a critical step as we are committed to bringing this important treatment to more U.S. GVHD patients.
"transplantantic-resistant host disease (GVHD) is an immune disease caused by the anti-host reaction of the transplant, which is the main complication of allogeneic hematopoietic stem cell transplantation and the main cause of death.
GVHD is divided into two forms, acute and chronic, which can affect a wide range of organ systems, the most common affected organs being the skin, gastrointestinal tract and liver.
clinically, most patients are treated with glucocorticoids, a class of steroid drugs that can lead to serious health complications over time.
ruxolitinib is an first-of-its-kind oral Janus kinase 1 and Janus kinase 2 (JAK1/JAK2) inhibitors.
the drug's current indications include: osteofibroma, true erythrocyte hyperactivity (PV), corticosteroid refractive acute transplantantite resistance to host disease (GVHD).
in the U.S. market, the drug brand, called Jakafi, is sold by Incyte, and outside the U.S., the drug brand is called Jakavi, which is sold by Novartis.
2019, Jakafi was approved by the U.S. FDA for the treatment of steroid refractive acute GVHD in adults and children up to 12 years of age, based on positive results from the Second PHASE REACH1 trial.
note, Jakafi is the first FDA-approved drug to treat the apparel, having previously been granted breakthrough drug qualification, orphan drug qualification, and priority review by the FDA.
data from the REACH1 study showed that 49 patients with steroid-only oricons had an ORR of 57% and CR 31% on the 28th day.
the most common adverse reactions observed in all 71 patients were infection (55%) and edema (51%), and the most common laboratory abnormalities were anemia (75%), platelet reduction (75%) and neutrophil decline (58%).
() Original source: Incyte Announces REACH3 Trial of Ruxolitinib (Jakafi ®) in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Key SecondaryS.