After a median three-year follow-up of patients in COMFORT-I, ruxolitinib treatment continued to maintain the previously reported reductions in spleen volume and improvements in quality of life measures. Overall survival favored patients originally randomized to ruxolitinib over those originally randomized to placebo (HR=0.69; 95% CI: 0.46-1.03; P=0.067). Additionally, because of the early crossover design in COMFORT-I, at the time of this analysis, patients originally randomized to placebo had been on ruxolitinib therapy a median of approximately two years, more than twice as long as their median time on placebo. Analyses were presented to show that because of the longer time these patients received Jakafi than placebo, the magnitude of the survival benefit observed may be underestimated relative to a comparison of ruxolitinib to a true placebo.
In a pooled analysis of COMFORT-I and COMFORT-II, intermediate-2-- and high-risk patients randomized to treatment with ruxolitinib had significantly prolonged survival compared to those randomized to placebo or best available therapy (HR = 0.65; 95% CI, 0.46-0.90; P = .01). Additionally, patients with high-risk myelofibrosis who were initially randomized to treatment with ruxolitinib had an estimated survival similar to patients with intermediate-2-risk myelofibrosis in the control group. Further analysis that corrects for the early crossover to ruxolitinib suggests that the survival benefit may be underestimated because patients in the placebo and best available therapy arms could cross over to receive ruxolitinib therapy. The authors also suggest that the survival benefit observed with ruxolitinib may be the result of multiple treatment effects, such as spleen volume reduction, improvement in symptoms, and improvement in nutritional status, which warrants further study.
Recent INCY News
- Multiple Late-Breaking Data Presentations from Incyte’s Dermatology Portfolio will be Featured at the European Academy of Dermatology and Venereology (EADV) 2024 Congress • Business Wire • 09/25/2024 11:00:00 AM
- Incyte and Syndax Announce New England Journal of Medicine Publication of Data from Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease • PR Newswire (US) • 09/18/2024 09:15:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/16/2024 05:25:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/16/2024 05:24:17 PM
- Retifanlimab (Zynyz®) von Incyte verlängert progressionsfreies Überleben bei Patienten mit Plattenepithel-Analkarzinom (SCAC) – Datenpräsentation beim ESMO Presidential Symposium 2024 • Business Wire • 09/15/2024 10:36:00 PM
- INCB123667, l'inhibiteur de la CDK2 d'Incyte, montre des signes prometteurs d'activité clinique chez des patientes atteintes de tumeurs solides avancées, notamment le cancer de l'ovaire • Business Wire • 09/15/2024 05:34:00 AM
- Incyte’s CDK2 Inhibitor INCB123667 zeigt vielversprechende Anzeichen von klinischer Wirkung bei Patienten mit soliden Tumoren in fortgeschrittenem Stadium • Business Wire • 09/15/2024 05:34:00 AM
- Le rétifanlimab (Zynyz®) d’Incyte prolonge la survie sans progression chez les patients atteints de carcinome épidermoïde du canal anal (SCAC) ; des données ont été présentées lors du Symposium présidentiel de l’ESMO 2024 • Business Wire • 09/15/2024 04:48:00 AM
- Incyte’s CDK2 Inhibitor INCB123667 Shows Promising Evidence of Clinical Activity in Patients with Advanced Solid Tumors, Notably Ovarian Cancer • Business Wire • 09/14/2024 04:45:00 PM
- Incyte’s Retifanlimab (Zynyz®) Extends Progression-Free Survival in Patients with Squamous Cell Anal Carcinoma (SCAC); Data Featured at ESMO 2024 Presidential Symposium • Business Wire • 09/14/2024 02:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/13/2024 08:06:55 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/12/2024 08:17:21 PM
- Incyte Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 09/09/2024 08:30:00 PM
- Incyte présentera les résultats de la phase 3 de Retifanlimab (Zynyz®) et les données initiales du programme d'inhibiteurs de CDK2 de phase 1 à l'édition 2024 du Congrès de la Société européenne d'oncologie médicale (ESMO) • Business Wire • 08/21/2024 08:49:00 PM
- Incyte präsentiert bahnbrechende Phase 3-Ergebnisse für Retifanlimab (Zynyz®) und erste Daten aus Phase 1 des CDK2-Inhibitor-Programms auf dem Kongress der European Society of Medical Oncology (ESMO) 2024 • Business Wire • 08/21/2024 08:49:00 PM
- Incyte to Present Late-Breaking Phase 3 Results for Retifanlimab (Zynyz®) and Initial Data from Phase 1 CDK2 Inhibitor Program at the European Society of Medical Oncology (ESMO) Congress 2024 • Business Wire • 08/21/2024 03:40:00 PM
- Incyte gibt positive Topline-Ergebnisse der Pivotalstudie mit Tafasitamab (Monjuvi®) bei rezidiviertem oder refraktärem follikulärem Lymphom bekannt • Business Wire • 08/16/2024 09:59:00 AM
- Incyte annonce des résultats positifs de l'étude pivot sur le tafasitamab (Monjuvi®) dans le lymphome folliculaire récidivant ou réfractaire • Business Wire • 08/16/2024 09:46:00 AM
- Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®) in Relapsed or Refractory Follicular Lymphoma • Business Wire • 08/15/2024 08:30:00 PM
- Incyte und Syndax melden FDA-Zulassung von Niktimvo™ (Axatilimab-csfr) zur Behandlung der chronischen Graft-versus-Host-Krankheit (GvHD) • Business Wire • 08/15/2024 08:15:00 PM
- Incyte et Syndax annoncent l’approbation par la FDA américaine de Niktimvo™ (axatilimab-csfr) pour le traitement de la maladie chronique du greffon contre l’hôte (GVHD) • Business Wire • 08/15/2024 10:26:00 AM
- Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD) • Business Wire • 08/14/2024 09:34:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 07:37:17 PM
- Incyte to Present at Upcoming Investor Conferences • Business Wire • 08/13/2024 12:00:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/12/2024 08:39:53 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM