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Incyte Reports 2017 Fourth-Quarter and Year-End Financial Results, Provides 2018 Financial Guidance and Updates on Key Clinical Programs

Nachrichtenquelle: Business Wire (engl.)
15.02.2018, 13:00  |  1543   |   |   

Incyte Corporation (Nasdaq: INCY) today reports 2017 fourth-quarter and year-end financial results, highlighting both strong growth in total revenue and the significant progress being made across the product portfolio.

“2017 was another successful year for Incyte with a fast-growing revenue line and an expanded portfolio of later-stage development candidates that we expect to drive our future growth,” stated Hervé Hoppenot, Incyte’s Chief Executive Officer. “As we begin 2018, we look forward to key newsflow events in the first half of the year, including the initial results of the ECHO-301 trial of epacadostat in melanoma and the REACH1 trial of ruxolitinib in steroid-refractory acute GVHD, as well as FDA action on the resubmission of the baricitinib NDA for rheumatoid arthritis.”

Portfolio Update

Oncology – key highlights

The pivotal REACH1 trial evaluating ruxolitinib in patients with steroid-refractory acute graft-versus-host disease (GVHD) has completed enrollment and results are expected in the first half of 2018. If successful, Incyte expects to submit an sNDA seeking approval of ruxolitinib in this indication.

Initial results, based on progression-free survival, from the pivotal ECHO-301 trial of epacadostat plus pembrolizumab in patients with unresectable or metastatic melanoma are expected in the first half of 2018. In collaboration with both Merck and Bristol-Myers Squibb, we have recently opened eight new pivotal trials of epacadostat plus PD-1 antagonists.

Initial data from the trial evaluating INCB54828 in patients with cholangiocarcinoma are expected in 2018.

Status updates for Incyte’s most advanced clinical programs are provided below.

             
      Indication     Status Update

Ruxolitinib
(JAK1/JAK2)

    Steroid-refractory acute GVHD     Pivotal Phase 2 (REACH1); Phase 3 (REACH2)

Ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD Phase 3 (REACH3)

Ruxolitinib
(JAK1/JAK2)

Essential thrombocythemia Phase 2 (RESET)

Itacitinib
(JAK1)

Treatment-naïve acute GVHD Phase 3 (GRAVITAS-301)

Itacitinib
(JAK1)

NSCLC Phase 1/2 in combination with osimertinib (EGFR)

Epacadostat
(IDO1)

Melanoma Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1)

Epacadostat
(IDO1)

Renal cancer Phase 3 (ECHO-302) in combination with pembrolizumab (PD-1)

Epacadostat
(IDO1)

Bladder cancer Phase 3 (ECHO-303 & ECHO-307) in combination with pembrolizumab (PD-1)

Epacadostat
(IDO1)

Head & neck cancer Phase 3 (ECHO-304) in combination with pembrolizumab (PD-1)

Epacadostat
(IDO1)

NSCLC Phase 3 (ECHO-305 & ECHO-306) in combination with pembrolizumab (PD-1)

Epacadostat
(IDO1)

NSCLC

Phase 3 (ECHO-309) in combination with nivolumab (PD-1)

Epacadostat
(IDO1)

Head & neck cancer

Phase 3 (ECHO-310) in combination with nivolumab (PD-1)

Epacadostat
(IDO1)

NSCLC Phase 3 in combination with durvalumab (PD-L1) expected to begin in H1 2018

MGA012
(PD-1)1

Solid tumors Phase 1 dose-escalation completed, monotherapy expansion cohorts ongoing

INCB50465
(PI3Kδ)

DLBCL Phase 2 (CITADEL-202)

INCB50465
(PI3Kδ)

Follicular lymphoma Phase 2 (CITADEL-203)

INCB50465
(PI3Kδ)

Marginal zone lymphoma Phase 2 (CITADEL-204)

INCB50465
(PI3Kδ)

Mantle cell lymphoma Phase 2 (CITADEL-205)

INCB54828
(FGFR1/2/3)

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