New Data for Presentation at ASCO 2017 Reinforce Clinical Profile of Epacadostat in Combination with Keytruda® (pembrolizumab)

Incyte’s IDO1 enzyme inhibitor in combination with Merck’s anti-PD-1 therapy is well-tolerated and demonstrates durable clinical responses across multiple solid tumors

WILMINGTON, DE. USA I May 17, 2017 I Incyte Corporation (Nasdaq:INCY) today announced the publication of new data from the ongoing ECHO-202 trial, evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. Abstracts published online by the American Society of Clinical Oncology (ASCO) in advance of its annual meeting in Chicago, Illinois, June 2-6, 2017 include ECHO-202 Phase 1/2 efficacy and safety data from the following cohorts: non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), bladder cancer, squamous cell carcinoma of the head and neck (SCCHN), triple-negative breast cancer (TNBC), and ovarian cancer (OVC). Pooled Phase 2 safety data across cohorts were also released today.

“We are very pleased to share these new data for epacadostat in combination with pembrolizumab. The combination is well-tolerated and preliminary efficacy outcomes for these cohorts demonstrate encouraging clinical activity, both within and across tumor types, which compares favorably to contemporary data in the second-line setting. These data, including updated data which will be presented at ASCO next month, supported the recently-announced progression of the epacadostat and pembrolizumab combination into pivotal trials in NSCLC, RCC, bladder cancer and SCCHN,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

ECHO-202 abstract data for the tumor types entering Phase 3 (data cut as of October 29, 2016) include:

                               
n/N
(%)
    NSCLC       UC       SCCHN       RCC
    All pts       0-2 prior lines of
therapy for advanced
disease
      All pts       Prior Lines of
Treatment
      All pts       Prior Lines of
Treatment
      All pts       Prior Lines of
Treatment
    Total       TPS ≥50%       TPS <50%       Total       0-1       Total       1-2       ≥3       Total       0-1       ≥2
ORR     14/40
(35)
      3/7
(43)
      6/17
(35)
      13/37
(35)
      10/27
(37)
      11/36
(31)
      10/29
(34)
      1/7
(14)
      9/30
(30)
      9/19
(47)
      0/11
(0)
    all PR       all PR       all PR       all PR       all PR       2 CR,
9 PR
      2 CR,
8 PR
      1 PR       1 CR,
8 PR
      1 CR,
8 PR
      -
DCR     24/40
(60)
      4/7
(57)
      9/17
(53)
      21/37
(57)
      17/27
(63)
      21/36
(58)
      18/29
(62)
      3/7
(43)
      15/30
(50)
      11/19
(58)
      4/11
(36)
                                                               
DoR     12/14 responses ongoing
range 1+ - 519 days
      12/13 responses ongoing
range 1+ - 652+ days
      9/11 responses ongoing
range 1+ - 563+ days
      9/9 responses ongoing
range 1+ - 372+ days
                               

In a pooled analysis evaluating 244 patients in the ECHO-202 Phase 2 safety population (abstract #3012), treatment-related adverse events (TRAEs) that occurred in ≥5 percent of patients, included fatigue (23 percent); rash (16 percent); diarrhea and nausea (7 percent each); increased alanine aminotransferase, increased aspartate aminotransferase, and pruritus (6 percent each); and pyrexia (5 percent). A total of 37 patients (15 percent) experienced Grade ≥3 TRAEs; the most common of which were increased lipase (asymptomatic) and rash (3 percent each). TRAEs led to discontinuation of treatment in 3 percent of study patients.

These abstracts, including data for TNBC and OVC (abstract #1103), were made available today on the ASCO website at www.asco.org.

About ECHO-202 (KEYNOTE-037)

The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with pembrolizumab. Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment is complete for the Phase 1 dose escalation (epacadostat 25, 50, 100 mg BID + pembrolizumab 2 mg/kg IV Q3W and epacadostat 300 mg BID + pembrolizumab 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + pembrolizumab 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit https://clinicaltrials.gov/ct2/show/NCT02178722.

About ECHO

The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies. ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind, placebo-controlled study investigating KEYTRUDA in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also underway. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)

Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

SOURCE: Incyte Pharmaceuticals

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