On August 30, 2017 Incyte Corporation (Nasdaq:INCY) reported that the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) has published an abstract (#1214O) containing new and updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with the anti-PD-1 KEYTRUDA (pembrolizumab), marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in patients with advanced melanoma (Press release, Immune Design, AUG 30, 2017, View Source [SID1234520341]).

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"We are encouraged by these additional data from our ECHO-202 trial, which demonstrate robust and durable responses in patients with advanced melanoma treated with the combination of epacadostat and KEYTRUDA," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These results further underscore the potential of this novel immunotherapy combination, and we look forward to reporting more detailed results from this study at ESMO (Free ESMO Whitepaper) next month."

Key Findings from the ECHO-202 Advanced Melanoma Cohort
Results of efficacy evaluable patients (N=54) as of February 27, 2017 include:

ECHO-202 Overall Response Rates (ORR), Disease Control Rates (DCR) and Durability of Response (DoR) in Advanced Melanoma
n/N
(%) All Patients
Treatment-Naïve
Advanced Melanoma
Patients

Treatment-Naïve
Advanced Melanoma
Patients
(epacadostat 100 mg BID)
ORR
30/54
(56)
25/45
(56)
18/30
(60)
8 CR (15)
22 PR (41)
6 CR (13)
19 PR (42)
2 CR (7)
16 PR (53)
DCR
42/54
(78)
35/45
(78)
Not yet reported
DoR 28/30 responses ongoing
Median (range) duration of response: 287.5+ (1+ to 763+) days

Across all efficacy-evaluable advanced melanoma patients, median progression-free survival (PFS) was 12.4 months, with PFS rates of 70 percent, 54 percent, and 50 percent at 6 months, 12 months, and 18 months respectively. In patients who were treatment-naïve for advanced disease, median PFS has not been reached, with landmark PFS rates of 68 percent, 52 percent, and 52 percent at 6 months, 12 months, and 18 months respectively.

Epacadostat in combination with KEYTRUDA was well-tolerated. The most common (≥15 percent) all grade treatment-related adverse events (TRAEs) were fatigue (39 percent), rash (33 percent), pruritus (27 percent), and arthralgia (16 percent). Grade ≥3 TRAEs were observed in 17 percent of patients; the most common were increased lipase (n=4), rash (n=3), and increased amylase (n=2). Three patients discontinued for TRAEs. No treatment-related deaths occurred.

The abstract was made available today on the ESMO (Free ESMO Whitepaper) Congress website at View Source

Updated data from ECHO-202 will be highlighted in an oral presentation on Saturday, 9 September 2017 from 15:00 – 15:15 CET at the ESMO (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain. Following the presentation, Incyte will host an investor conference call and webcast at 17:00 CET (11:00 a.m. ET) on 9 September 2017—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of www.incyte.com.

About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA. 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 + KEYTRUDA 2 mg/kg IV Q3W and epacadostat 300 mg BID + KEYTRUDA 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + KEYTRUDA 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit View Source

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 are evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors 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 ongoing and fully recruited. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)
The immunosuppressive effects of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme activity on the tumor microenvironment help cancer cells evade immunosurveillance. Epacadostat is an investigational, highly potent and selective oral inhibitor of the IDO1 enzyme. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck and bladder cancer. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitors KEYTRUDA or nivolumab improved response rates compared with studies of the immune checkpoint inhibitors alone.