WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) today announced that the pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD) did not meet the primary endpoint of improving overall response rate (ORR) at Day 28 compared to placebo plus corticosteroids (74.0 percent vs. 66.4 percent, p=0.08, respectively). To access the replay you will need the conference identification number, 13697736. For additional information on Incyte, please visit Incyte.com and follow @Incyte. Allergy and immunology Cancers New Medicines NHS England commissioned new medicines. Because this pathway can be inhibited by imatinib, we performed a pilot study including 19 patients with refractory cGVHD, given imatinib at a starting dose of 100 mg per day. In addition, there was no difference observed in non-relapse mortality (NRM) at Month 6, the study’s key secondary endpoint, between the treatment and placebo arms. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. ET on January 2, 2020. New molecular entity . Use of growth factors or platelet transfusions is not allowed within 7 days before screening of laboratory assessment. Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Overall response rate (ORR) [ Time Frame: Approximately 6 months after the beginning of study drug treatment ], Number of patients that can withdraw or decrease steroids [ Time Frame: Steroid dose will be assessed prior to first dose of study treatment, throughout study treatment, and when study treatment ends (approximately 1 year) ], Overall survival [ Time Frame: Survival will be assessed every 3 months for 1 year after last dose of study treatment ], Assessment of safety based on frequency of adverse events [ Time Frame: Safety will be assessed throughout study treatment until 30 days after the last dose of study treatment (approximately 1 year) ], Quality of life impact [ Time Frame: Quality of life will be assessed prior to the start of study treatment, at two timepoints while receiving study treatment, and when study treatment ends (approximately 1 year) ], Number of patients with recurrence or progression of cGVHD [ Time Frame: cGVHD status will be assessed prior to the start of study treatment, throughout study treatment, and when study treatment ends (approximately 1 year) ], Relapse rate of underlying malignancy [ Time Frame: Relapse of underlying malignancy will be assessed throughout study treatment, when study treatment ends, and every 3 months for 1 year after last dose of study treatment (approximately 2 years) ], Written informed consent signed by the patient or legal guardian prior to any study-related screening procedures. Incyte. The safety profile observed in GRAVITAS-301 was consistent with that observed in previously reported studies of itacitinib in combination with corticosteroids. +1 302 498 5914 Keywords provided by SCRI Development Innovations, LLC: Why Should I Register and Submit Results? Types. Identification of novel therapeutic targets are needed to improve outcomes. Moderate cGVHD: at least 1 organ (except lung) with a score of 2, ≥3 organs involved with a score of 1 in each organ, or lung score of 1, Severe cGVHD: at least 1 organ with a score of 3, or lung score of 2 or 3, Patient is refractory to glucocorticoid therapy at screening: ongoing treatment with prednisone equivalent ≥0.20 mg/kg/day x 4 weeks (wks) at screening and organ progression documented 4 wks after the initiation of this regimen, Patient is dependent on glucocorticoid therapy at screening: treatment with a prednisone equivalent mean dose ≥0.20 mg/kg/day received for 12 wks at screening, Patient is intolerant to glucocorticoids at screening: ongoing treatment with prednisone equivalent ≥0.20 mg/kg/day x 4 wks at screening and presence of at least one documented glucocorticoid toxicity. Patients receiving treatment with medications that interfere with coagulation or platelet function including, but not limited to, aspirin dose exceeding 81 mg/day and related drugs such as heparin or warfarin sodium. Choosing to participate in a study is an important personal decision. References. Mouse models of GvHD have provided important in … Allogeneic hematopoietic cell transplantation (alloHCT) is potentially curative for a variety of hematologic malignancies .An important component is the graft-versus-leukemia (GVL) response , in which alloreactive (antirecipient) donor T cells target recipient tumor cells, inhibiting relapse .Graft-versus-host disease (GVHD) is a potentially fatal complication of alloHCT. However, the difference in ORR for the treatment arm compared with the placebo arm was not statistically significant, missing the trial’s primary end point. Company name UK. Because itacitinib is a JAK1-specific inhibitor, it could be a better option than JAK1/2 dual inhibitor Jakafi. Introduction. We previously reported that patients with fibrotic, chronic graft-versus-host disease (cGVHD) have antibodies activating the platelet-derived growth factor receptor pathway. GRAVITAS-301 is a randomized, double-blind, placebo-controlled pivotal Phase III trial. Patients with relapsed primary malignancy, or who have been treated for relapse after the allo-HSCT was performed, History of progressive multifocal leukoencephalopathy. Talk with your doctor and family members or friends about deciding to join a study. Itacitinib was discovered at Incyte, and Incyte holds the global development and commercialization rights for itacitinib with the exception of China, where the rights to develop and commercialize itacitinib have been licensed to Innovent Biologics, Inc. Incyte will host a conference call at 5:00 p.m. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. It is being evaluated as first-line treatment for both acute and chronic GVHD. The purpose of this study is to assess how safe and well tolerated itacitinib is in combination with corticosteroids compared to placebo in patients who have cGVHD. Itacitinib (INCB039110, Incyte) is a novel JAK1 inhibitor under investigation for chronic and acute GVHD. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection progression are present. Please remove one or more studies before adding more. Itacitinib is a JAK-1 selective inhibitor that improved graft-versus-host disease (GVHD) and survival without affecting engraftment of donor leukocytes in murine models. The drug is developed specifically for chronic GVHD. Widespread skin rashes are among the common symptoms of chronic graft-versus-host disease. Changes in symptom burden will be measured using the Lee Symptom Scale. When prompted, provide the conference identification number, 13697736. Treatment with any other investigational agent, device, or procedure, within 28 days (or 5 half-lives, whichever is longer) of enrollment. ET. Data from this study will be submitted for presentation at an upcoming scientific meeting. GRAVITAS-301 (NCT03139604) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo, in combination with corticosteroids, as a first-line treatment for patients with acute GVHD. Outcome. ClinicalTrials.gov Identifier: NCT04200365, Interventional dm+d. Updated October 14, 2020. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Young cut Incyte’s price target to a Street low of $65 from $75 and lowered her probability of overall success of itacitinib for chronic GVHD to 25% from 75%. The most common adverse events were thrombocytopenia (34.9 percent for itacitinib and 34.7 percent for placebo) and anemia (29.8 percent for itacitinib and 25.0 percent for placebo). Graft versus host disease (GVHD) remains a major cause of morbidity and mortality following allogeneic hematopoietic stem-cell transplantation (HSCT). View all . If you are unable to participate, a replay of the conference call will be available for 30 days. ClinicalTrials.gov. Itacitinib added to corticosteroids improved the overall response rate in patients with treatment-naïve acute GVHD; however, the difference versus placebo plus corticosteroids was not statistically significant. GRAVITAS-119: A phase I trial of itacitinib plus calcineurin inhibitor-based regimens for GvHD prophylaxis. The targeted cancer therapy ibrutinib (Imbruvica®) can effectively treat a common and serious complication of a type of stem cell transplant, findings from a small clinical trial show. Itacitinib Published 16 August 2018, updated 17 January 2021. Company name US. Incyte. Placebo arm. The conference call will also be webcast live and can be accessed at www.incyte.com in the Investors section under “Events and Presentations.”. A study of itacitinib or placebo in combination with corticosteroids for treatment of acute graft-versus-host disease. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2. Media Catalina Loveman Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms. The company will do a six-month futility analysis to gauge the trial's likelihood of success, however. Itacitinib is a novel and selective JAK1 inhibitor. Suppression of the immune system with corticosteroids forms the basis of first-line therapy for management of GVHD, but sustained responses are usually seen in less than 50 percent of patients and there is no standard second- or third-line treatment for steroid refractory cGVHD. By … Ability to understand the nature of this study and to comply with study and follow-up procedures, Has received ˃1 prior allo-HSCT or donor lymphocyte infusion, Receiving concomitant JAK inhibitor for cGVHD; prior treatment with a JAK inhibitor for acute GVHD is permitted. “The result of this study is disappointing. The primary endpoint is overall response rate (ORR) at Day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Company’s ongoing clinical development program for itacitinib, development plans for ruxolitinib and further development in GVHD, contain predictions, estimates and other forward-looking statements. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. The double-blind, placebo-controlled GRAVITAS-301 study compared the addition of … The pivotal Phase 3 … Therapeutic potential has been shown by a JAK inhibitor in the treatment of steroid refractory GVHD. The key secondary endpoint is non-relapse mortality at Month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse. GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD). Accessed March 1, 2021. Despite the use of prophylactic GVHD regimens, a significant proportion of transplant recipients will develop acute or chronic GVHD … Entry type. A regimen of systemic corticosteroids is considered first-line therapy but is often associated with inadequate respon …. Therapeutic potential has been shown by a JAK inhibitor in the treatment of steroid refractory GVHD. Active uncontrolled bacterial, fungal, parasitic, or viral infection. You have reached the maximum number of saved studies (100). Women of childbearing potential who have a negative serum pregnancy test at screening and who agree to take appropriate precautions to avoid pregnancy from screening through safety follow-up. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. cGvHD, chronic GvHD; CI, confidence interval; DoR, duration of response; FFS, failure-free survival; GvHD, graft-versus-host disease; NRM, non-relapse mortality; OS, overall survival *Median follow-up of 267 days for both arms † Median follow-up was 130 days for the placebo arm and 148 days for itacitinib. Evidence of myeloid and platelet engraftment (absolute neutrophil count ˃1,000/mm^3 and platelet count ˃25,000/mm^3). Itacitinib will be administered orally once daily for up to 12 months. Additionally we will continue to study the role of JAK inhibition in chronic GVHD and in the prophylactic setting, as we seek to develop treatments for patients with this debilitating and often fatal disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte. Listing a study does not mean it has been evaluated by the U.S. Federal Government. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). Known allergies, hypersensitivity, or intolerance to itacitinib or any of its excipients, Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. Itacitinib is a novel, selective inhibitor of the JAK family of protein tyrosine kinases and will be studied here in patients with steroid refractory cGVHD. Patients will be assessed for severity of cGVHD using clinician- and patient-reported activity assessments and review of steroid dose, Patients will be closely monitored for any evidence of underlying disease relapse or recurrence; Formal re-staging will be done at physician discretion. However, we remain committed to building on the success of the REACH program for ruxolitinib, which showed positive results in steroid refractory acute GVHD. Chronic graft-versus-host disease (cGVHD) continues to be a major complication after allogeneic hematopoietic cell transplantation, significantly affecting patients' quality of life. Part 1 of this study is closed to enrollment. The limiting factor for successful hematopoietic stem cell transplantation (HSCT) is graft-versus-host disease (GvHD), a post-transplant disorder that results from immune-mediated attack of recipient tissue by donor T cells contained in the transplant. While itacitinib added to corticosteroids improved the ORR in patients with treatment-naïve acute GVHD, the difference observed versus placebo plus corticosteroids was not statistically significant. Graft versus host disease remains a major hurdle to improve allogeneic hematopoietic stem cell transplantation outcome, with cGVHD being associated with decreased quality of life. The overall response rate was improved with itacitinib plus corticosteroids compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease in the phase III GRAVITAS-301 trial. mbooth@incyte.com, Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease, https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2. cloveman@incyte.com, Investors 1. Incyte announces results of phase 3 study of itacitinib in patients with treatment-naïve acute graft-versus-host disease [news release]. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD. Recipients of non-myeloablative, myeloablative, and reduced intensity conditions are eligible. Unassigned New Medicines Chronic graft versus host disease (GvHD) Information. Active tuberculosis infection that developed after allo-HSCT, Active viral infection confirmed by polymerase chain reaction for the BK virus ( a polyoma virus), cytomegalovirus, Epstein-Barr virus, and human herpes virus 6, Active hepatitis B virus (HBV) or hepatitis C virus that requires treatment, or at risk for HBV reactivation (i.e., positive HBsAg), Cholestatic disorders or unresolved veno-occlusive disease of the liver (persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction), Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral itacitinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowl resection), Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy, Significant respiratory disease that requires mechanical ventilation support or a resting O2 saturation ˂90 percent by pulse oximetry or FEV1 ˂30 percent, Patients requiring platelet transfusions to maintain a platelet count ˃25,000/mm^3, Any corticosteroid therapy for indications other than cGVHD at doses ˃1 mg/kg/day methylprednisone or equivalent within 7 days of study start. Defined as the proportion of patients with a cGVHD response of complete response (CR) or partial response (PR) after 6 months of treatment as defined by National Institutes of Health Consensus Criteria, Ability to withdraw or decrease steroids to ˂0.5 mg/kg of methylprednisolone or equivalent, Defined as the time from the first day of study drug administration to death on study, Safety will be assessed in terms of adverse events. Use of low molecular weight heparin is allowed. Results from GRAVITAS-309, which is testing itacitinib in chronic GvHD, aren't expected for years. - GRAVITAS-301 results show that treatment with itacitinib in combination with corticosteroids did not statistically improve overall response rate or non-relapse mortality compared to placebo plus corticosteroids, - Conference call scheduled today at 5:00 p.m. Other secondary endpoints include duration of response. Itacitinib (INCB039110) is a novel, potent, and selective JAK1 inhibitor currently in clinical studies for the treatment of treatment naïve GVHD and non-small cell lung cancer. Michael Booth, DPhil Incyte Doses First Patient in Phase III Study of GVHD Candidate Itacitinib. Itacitinib is a novel, selective inhibitor of the JAK family of protein tyrosine kinases and will be studied here in patients with steroid refractory cGVHD. Ibrutinib Relieves Chronic Graft-Versus-Host Disease Symptoms. Men who agree to take appropriate precautions to avoid fathering children from screening through safety follow-up. Ruxolitinib as Salvage Therapy for Chronic Graft-versus-Host Disease. Graft-versus-host disease. The Company disclaims any intent or obligation to update these forward-looking statements. For previous study drugs where 5 half-lives is ≤28 days, a minimum of 10 days between termination of that study drug and administration of itacitinib is required. Patients must currently be receiving systemic or other immunosuppressive therapies for the treatment of cGVHD for a duration of ˃6 months prior to start of study treatment, Patients must be able to swallow and retain oral medication, Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2, Adequate renal function: creatinine clearance ≥30 mL/min measured or calculated by Cockcroft Gault equation, Women of non-childbearing potential (i.e., surgically sterile by hysterectomy and/or bilateral oophorectomy OR ≥12 months of amenorrhea). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Patients who have undergone one allo-hematopoietic stem cell transplant (HSCT) from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Chronic graft-versus-host disease. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200365. Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient. This study has 3 parts, Part 1, Part 1 Expansion, and Part 2. For general information, Learn About Clinical Studies. Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria: cGVHD must be refractory to steroids defined by at least one criteria: Patients willing to avoid pregnancy or father children based on 1 of the following: Severe organ dysfunction unrelated to underlying GVHD including: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Itacitinib is also being evaluated in combination with corticosteroids compared with placebo and corticosteroids as a frontline therapy for patients with chronic GVHD in the phase III GRAVITAS-309 trial (NCT03584516). Nearer on the horizon is a Food and Drug Administration decision on pemigatinib, a liver cancer drug Incyte submitted for approval late last year. Janus kinases (JAKs) mediate the signaling of proinflammatory cytokines involved in the pathogenesis of cGVHD. You would be participating in Part 2. Incyte’s JAK1 inhibitor itacitinib has failed a key trial in graft-versus-host disease (GVHD), marking another setback for a company in need of more drug successes. Information provided by (Responsible Party): This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. A phase 3 trial of Incyte’s itacitinib in treatment-naive acute graft-versus-host disease (GVHD) has missed its primary endpoint, wiping around $2 billion off the biotech’s market cap. GRAVITAS-301 (NCT03139604) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo, in combination with corticosteroids, as a first-line treatment for patients with acute GVHD. Male patients must also refrain from donating sperm during their participation in the study and for at least 3 months after completing the study. +1 302 498 6171  (Clinical Trial), A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease, 18 Years and older   (Adult, Older Adult), Contact: Sarah Cannon Development Innovations, LLC, Nashville, Tennessee, United States, 37203. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Another recently launched pivotal trial is testing the candidate for chronic GVHD. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2019. Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. Identification of novel therapeutic targets are needed to improve outcomes. Unlike the acute form of the condition, which comes on within months of the transplant, chronic GVHD …
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