Incyte (INCY) Announces Publication of Updated Phase 1 Data on Epacadostat + Keytruda in Advanced Melanoma (MRK)

September 28, 2016 6:16 AM EDT

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Incyte Corporation (Nasdaq: INCY) announced that the European Society for Medical Oncology (ESMO) has published an abstract (#1110PD) containing updated data from the Phase 1 portion of the ECHO-202 trial evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. These data will be highlighted in a poster discussion on Monday, 10 October 2016 from 11:00-12:00 CET at the ESMO Annual Congress 2016 in Copenhagen, Denmark.

In patients with treatment-naïve advanced melanoma (n=19), updated data show a disease control rate (DCR) of 74 percent and an overall response rate (ORR) of 58 percent. All responses are confirmed and ongoing (median follow-up 42 weeks); median progression-free survival (PFS) has not been reached.

“We are very pleased that after extended treatment and longer follow-up, these updated Phase 1 data for epacadostat in combination with pembrolizumab demonstrate robust, durable clinical activity in patients with treatment-naïve advanced melanoma and reinforce the promise of IDO1 inhibition in combination with an anti-PD-1 therapy as an important component of immunotherapy,” said Steven Stein, M.D., Incyte’s Chief Medical Officer.

Epacadostat in combination with pembrolizumab was well-tolerated. The most common (≥15%) all grade treatment-related adverse events (TRAEs) were fatigue, rash, arthralgia, pruritus, diarrhea and nausea. Grade ≥3 TRAEs were observed in 18% of patients; the most common were rash (8%) and increased lipase (3%).

The ECHO-202 abstract was made available today on the ESMO Congress website at http://esmo.org/Conferences/ESMO-2016-Congress.

The ECHO-202 poster is expected to be made available to attendees at the ESMO Congress on Friday, 7 October 2016, at which time the ECHO-202 poster will be made available via the Events and Presentations tab of the Investor section of www.incyte.com. Incyte will also host an investor conference call and webcast at 14:00 CET (8:00 a.m. ET) on 7 October 2016 which 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 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 the 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 as first-line treatment for 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.

Conference Call Information

To access the conference call, please dial 877-407-9221 for domestic callers or +1-201-689-8597 for international callers. When prompted, provide the conference identification number, 13644034.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415. To access the replay you will need the conference identification number, 13644034.



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