Incyte releases positive data for the first innovative drug against acute immune response after transplantation
Incyte releases positive data for the first innovative drug against acute immune response after transplantation
June 25, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Incyte announced positive results in its ongoing two-phase REACH1 trial, which evaluated Jakafi® (ruxolitinib, rosolidinib) in combination with corticosteroids for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) effect.
In 2016, Incyte and Lilly revised the licensing, development and commercialization agreements for ruxolitinib, enabling Inycte to independently develop and commercialize the drug for the treatment of GVHD. In April of this year, Incyte and Novartis revised the cooperation and licensing agreement to grant Novartis the right to research, develop and commercialize ruxolitinib in the treatment of GVHD in countries outside the United States. Subsequently, the FDA granted the drug a breakthrough drug qualification (BTD) for the treatment of acute GVHD.
The results of this trial showed that the drug's therapeutic effect reached the primary endpoint, showing an overall response rate (ORR) of 55% after treatment day 28 (n = 39/71), and the best overall response rate during the response study period. (BORR) was 73% (n = 52/71). The most common treatment-related adverse events in the trial were anemia (61%), thrombocytopenia (61%), and neutropenia (56%).
Based on these data from REACH1, Incyte plans to submit a Supplemental New Drug Application (sNDA) to the FDA in the third quarter of 2018. "The results of the REACH1 study suggest that ruxolitinib can effectively improve the outcome of allogeneic transplant patients with refractory acute GVHD and further emphasize the prospects of JAK inhibition, thereby promoting this," said Stein Medical, Ph.D. Treatment of potentially devastating diseases. We look forward to sharing the results of this study with the medical community and working with US regulators to submit our new drug application for approval of the drug for GVHD indications later this year."
Jakafi is a world-first-in-class oral Janus kinase 1 and Janus kinase 2 (JAK1/JAK2) inhibitor. In the United States, the drug was approved by the FDA in November 2011 as the first drug to treat bone marrow fibrosis for the treatment of intermediate-risk and high-risk bone fibrosis, including primary myelofibrosis and myelofibrosis after polycythemia And patients with myelofibrosis after essential thrombocytosis. In December 2014, the FDA further approved Jakafi for the treatment of polycythemia (PV), which is inadequate or intolerant to hydroxyurea, the first FDA-approved PV treatment. In the European Union, Jakafi was awarded bone mineralization and PV indications in August 2012 and March 2015, respectively, which was also the first bone fibrosis approved in Europe and the first PV treatment.
Dr. Madan Jagasia of Vanderbilt University Medical Center said, "In recent years, more and more patients have undergone allogeneic or donor transplant surgery. Unfortunately, the incidence of graft-versus-host disease is also Gradually, the disease is closely related to the mortality rate in the first year after transplantation. The mortality rate will be about 25%-75% depending on the grade or progress of the disease. Although there is a corresponding treatment plan for acute GVHD, it cannot Ensuring that they respond to patients, and these refractory patients are in desperate need of new and innovative treatments."
Graft-versus-host disease (GVHD) is an immune disease caused by graft-versus-host response and is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death. In GVHD, donated bone marrow or peripheral blood stem cells treat the recipient's body as a foreign object and attack the body. GVHD is available in both acute and chronic forms and can affect a variety of organ systems. The most common affected organs are the skin, gastrointestinal tract and liver. Currently, there are no approved drugs for the treatment of GVHD. (Sina Pharmaceutical Compilation / Fan Dongdong)
　　 Article Reference Source: Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi®) in Steroid-Refractory Acute Graft-Versus-Host Disease
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