Incyte Aktie
WKN: 896133 / ISIN: US45337C1027
19.09.2024 03:00:19
|
Incyte: Phase 2 Trial Results Of Niktimvo In Chronic Graft-Versus-Host Disease Meet Primary Goal
(RTTNews) - Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that results from the pivotal Phase 2 AGAVE-201 trial of Niktimvo(axatilimab-csfr), an anti-CSF-1R antibody, in adult and pediatric patients with recurrent/refractory active chronic graft-versus-host disease or GVHD who had received at least two prior lines of systemic therapy were published in The New England Journal of Medicine.
The AGAVE-201 pivotal trial enrolled 241 patients with recurrent or refractory chronic GVHD who had received two or more prior systemic therapies, with 74% having previously received ruxolitinib, 31% having previously received ibrutinib and 23% having previously received belumosudil. Patients were enrolled across 121 sites in 16 countries.
The results show that the trial met the primary endpoint across all cohorts receiving Niktimvo at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks. Patients in the 0.3 mg/kg every two weeks cohort achieved the highest overall response rate (ORR) of 74% within the first six months of treatment. Patients in this cohort experienced a median time to response to Niktimvo of 1.7 months. Among the patients who had a response in the 0.3 mg/kg dose cohort, an estimated 60% of patients maintained a response at 12 months.
Clinically meaningful reduction in chronic GVHD symptoms was reported by 60% of patients in the 0.3 mg/kg dose cohort. In the same cohort, organ-specific responses, including complete responses (CRs), were seen across all organs studied, including lower gastrointestinal (GI), upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin.
Additionally, responses were notable in fibrosis-dominated organs, including the esophagus (78%), joints and fascia (76%), lungs (47%) and skin (26%). Responses were observed across key patient subgroups, including objective response rates =75% in the 0.3 mg/kg cohort who received prior ibrutinib, ruxolitinib, and/or belumosudil.
On August 14, 2024, Incyte and Syndax announced the U.S. Food and Drug Administration's approval of Niktimvo for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs), with a recommended dosage of 0.3 mg/kg, up to a maximum dose of 35 mg, as an intravenous infusion over 30 minutes every two weeks until progression or unacceptable toxicity.
In the United States, Niktimvo will be co-commercialized by Incyte and Syndax Pharmaceuticals. Incyte has exclusive commercialization rights for Niktimvo outside of the U.S. The Companies anticipate launching Niktimvo in the U.S. no later than early first quarter 2025.
For More Such Health News, visit rttnews.com.

Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Incyte Corp.mehr Nachrichten
16:03 |
S&P 500-Wert Incyte-Aktie: So viel hätte eine Investition in Incyte von vor einem Jahr abgeworfen (finanzen.at) | |
27.03.25 |
S&P 500-Titel Incyte-Aktie: So viel Verlust hätte eine Investition in Incyte von vor 10 Jahren bedeutet (finanzen.at) | |
21.03.25 |
Schwache Performance in New York: So entwickelt sich der S&P 500 am Freitagnachmittag (finanzen.at) | |
21.03.25 |
Anleger in New York halten sich zurück: S&P 500 zeigt sich leichter (finanzen.at) | |
20.03.25 |
S&P 500-Wert Incyte-Aktie: So viel Verlust hätte eine Incyte-Investition von vor 5 Jahren eingebracht (finanzen.at) | |
17.03.25 |
S&P 500 aktuell: S&P 500 zum Ende des Montagshandels mit grünem Vorzeichen (finanzen.at) | |
17.03.25 |
Montagshandel in New York: S&P 500 notiert nachmittags im Plus (finanzen.at) | |
17.03.25 |
Freundlicher Handel in New York: S&P 500 mit grünem Vorzeichen (finanzen.at) |
Analysen zu Incyte Corp.mehr Analysen
Aktien in diesem Artikel
Incyte Corp. | 56,58 | -1,36% |
|
Syndax Pharmaceuticals Inc | 11,20 | -5,88% |
|