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Incyte (INCY) Discontinues Jakafi Combo Myelofibrosis Study
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Incyte (INCY - Free Report) announced that it will discontinue the late-stage LIMBER-304 study following the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC).
LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus Jakafi (ruxolitinib) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.
The IDMC advised that the study is unlikely to meet its primary endpoint and hence Incyte decided to discontinue the study. The primary endpoint of LIMBER-304 was the proportion of patients who achieved a targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography. Secondary endpoints included the proportion of patients who had a targeted reduction in Total Symptom Score (TSS), change in TSS, time to the first ≥50% reduction in TSS, overall survival, number of treatment-emergent adverse events, time of onset of the targeted reduction in spleen volume and the duration of the targeted reduction in spleen volume maintenance.
The LIMBER clinical trial program is evaluating multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD. These include ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab and novel targets such as mutant CALR.
Jakafi, a first-in-class JAK1/JAK2 inhibitor, is Incyte’s lead drug and is approved for polycythemiavera, MF and refractory acute graft-versus-host disease.
Incyte recently reported better-than-expected fourth-quarter results, driven by growth in patient demand for the lead drug, Jakafi, higher royalty revenues and encouraging uptake of other recently approved drugs.
The successful development of other drugs will add an incremental stream of revenues to the top line and reduce the company’s dependence on Jakafi.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi, which is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
While Jakafi’s sales and royalties are key catalysts for the company’s revenue growth, Iclusig’s sales and Olumiant’s royalties from Eli Lilly (LLY - Free Report) also contribute to the top line.
Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases.
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Incyte (INCY) Discontinues Jakafi Combo Myelofibrosis Study
Incyte (INCY - Free Report) announced that it will discontinue the late-stage LIMBER-304 study following the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC).
LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus Jakafi (ruxolitinib) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.
The IDMC advised that the study is unlikely to meet its primary endpoint and hence Incyte decided to discontinue the study. The primary endpoint of LIMBER-304 was the proportion of patients who achieved a targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography. Secondary endpoints included the proportion of patients who had a targeted reduction in Total Symptom Score (TSS), change in TSS, time to the first ≥50% reduction in TSS, overall survival, number of treatment-emergent adverse events, time of onset of the targeted reduction in spleen volume and the duration of the targeted reduction in spleen volume maintenance.
The LIMBER clinical trial program is evaluating multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD. These include ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab and novel targets such as mutant CALR.
Jakafi, a first-in-class JAK1/JAK2 inhibitor, is Incyte’s lead drug and is approved for polycythemiavera, MF and refractory acute graft-versus-host disease.
Incyte recently reported better-than-expected fourth-quarter results, driven by growth in patient demand for the lead drug, Jakafi, higher royalty revenues and encouraging uptake of other recently approved drugs.
The successful development of other drugs will add an incremental stream of revenues to the top line and reduce the company’s dependence on Jakafi.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi, which is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
While Jakafi’s sales and royalties are key catalysts for the company’s revenue growth, Iclusig’s sales and Olumiant’s royalties from Eli Lilly (LLY - Free Report) also contribute to the top line.
Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases.