On October 7, 2016 Incyte Corporation (Nasdaq:INCY) reported that updated data from the Phase I portion of the ECHO-202 trial evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with pembrolizumab (Keytruda)*, Merck’s anti-PD-1 therapy, have been published as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2016 in Copenhagen, Denmark (Press release, Incyte, OCT 7, 2016, View Source [SID:SID1234515643]). Schedule your 30 min Free 1stOncology Demo! Further to the previously published abstract, today’s updated data show that among patients with treatment-naïve advanced melanoma (n=19), the combination of epacadostat plus pembrolizumab resulted in progression-free survival (PFS) rates of 74 percent and 57 percent at 6 months and 12 months, respectively. Median PFS has not been reached. The updated data also show an increase in the complete response (CR) rate to 26 percent. The objective response rate (ORR) and disease control rate (DCR) remained consistent with the previously published abstract data, at 58 percent and 74 percent, respectively. All responses are confirmed and ongoing (median follow-up among responders 56 plus [range of 46 to 90 plus] weeks).
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"We are excited to share further data with additional follow-up from the Phase 1 portion of the ECHO-202 study," said Steven Stein, M.D., Incyte’s Chief Medical Officer. "The durable responses seen in patients with treatment-naïve advanced or metastatic melanoma reaffirm the activity of this immunotherapy combination, and we look forward to the read-out of ECHO-301, the ongoing, pivotal Phase 3 trial."
Epacadostat in combination with pembrolizumab was well tolerated in the Phase 1 population (n=62). The most common (≥15%) all grade treatment-related AEs (TRAEs) were fatigue, rash, pruritus, arthralgia, diarrhea and nausea. Grade ≥3 TRAEs were observed in 19 percent of patients; the most common were rash (8%) and increased lipase (5%). Five patients (8%) discontinued treatment due to TRAEs.
The ECHO-202 poster was made available to attendees at the ESMO (Free ESMO Whitepaper) Congress today, Friday, 7 October, and will be made available via the Events and Presentations tab of the Investor section of www.incyte.com. Incyte will host an investor conference call and webcast at 14:00 CET (8:00 a.m. ET) today, 7 October 2016, which can also 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 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. Enrollment in Phase 2, tumor-specific, cohorts is ongoing.
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 evaluating pembrolizumab in combination with epacadostat or placebo for the first-line treatment of patients with advanced or metastatic melanoma, is also underway. ECHO-301 was initiated in June 2016 and initial data from this study are expected to be available in 2018.
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 reverses tumor-associated immune suppression and restores 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.