Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi®) in Steroid-Refractory Acute Graft-Versus-Host Disease
Results support planned sNDA submission in 2018
Based on these data from REACH1,
“The results of the REACH1 study demonstrate the potential of
ruxolitinib to meaningfully improve the outcomes of allogeneic
transplant patients who develop steroid-refractory acute GVHD and
further underscore the promise of JAK inhibition to advance the
treatment of this potentially-devastating condition,” said
Full detailed results from the REACH1 study will be submitted for presentation at an upcoming scientific meeting.
GVHD is a condition that can occur after an allogeneic transplant (the transfer of genetically dissimilar blood stem cells) and is a significant cause of morbidity and mortality in transplant recipients. In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.
"As the use of allogeneic – or donor – transplants has increased,
unfortunately so has the prevalence of GVHD, which is associated with
first-year mortality ranging from 25 to 75 percent depending on the
grade or progression of the disease,” said
The REACH clinical trial program for ruxolitinib in steroid-refractory
acute GVHD includes the
The primary endpoint of the REACH1 study is overall response rate at day 28. Key secondary endpoints include duration of response, overall response rate at day 14, 56 and 100, non-relapse mortality and safety. For more information about the study, please visit https://clinicaltrials.gov/show/NCT02953678.
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.
Jakafi is marketed by
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including statements regarding plans to
present additional study data at an upcoming scientific meeting, the
plan to file an sNDA for the approval of ruxolitinib for the treatment
of steroid-refractory acute GVHD with the