Incyte Announces First Patient Treated In ECHO-301 Phase 3 Study

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today announced that the first patient has been treated in the ECHO-301 study—a Phase 3 trial evaluating epacadostat, Incyte’s investigational, highly potent and selective oral IDO1 inhibitor, in combination with Keytruda^® (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma. Incyte expects initial data from the ECHO-301 study to be available in 2018.

“This trial—the first to test this combination in a pivotal study—is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types.”

“We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase 3 program evaluating epacadostat in combination with pembrolizumab,” said Steven Stein, M.D. Incyte’s Chief Medical Officer. “This trial—the first to test this combination in a pivotal study—is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types.”

Melanoma, the most serious form of skin cancer, strikes adults of all ages. In the U.S., melanoma accounts for approximately five percent of all new cases of cancer each year. The incidence of melanoma continues to rise by almost three percent each year which translates to 76,000 new cases yearly in the U.S. alone.¹ In the European Union, there are approximately 41,000 new cases of melanoma per year and approximately 11,000 deaths annually.²

About ECHO-301 (Keynote-252/NCT02752074)

This Phase 3 randomized, double-blind, placebo-controlled study will evaluate pembrolizumab in combination with epacadostat or placebo in patients with unresectable or metastatic melanoma. ECHO-301 will enroll 600 patients, randomized 1:1, who will be stratified by PD-L1 expression (positive versus negative/indeterminate) and BRAF mutation status (BRAF mutant who have received prior BRAF-directed treatment or BRAF mutant with no prior BRAF-directed treatment and BRAF wild type).

The two primary endpoints of the study are progression-free survival and overall survival. Key secondary endpoints include objective response rate, safety and tolerability.

ECHO-301 is co-sponsored by Incyte and Merck. For more information about the study, please visit https://clinicaltrials.gov/show/NCT02752074.

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. Ongoing Phase 1 and Phase 2 studies are investigating epacadostat in combination with PD-1 and PD-L1 inhibitors in a variety of other cancer histologies.

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.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements with respect to the design and expected progress of, and release of data from, the ECHO-301 study the efficacy of such trial and the effect such trial may have on patient outcomes, and the evaluation of epacadostat in other clinical programs, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2016. Incyte disclaims any intent or obligation to update these forward-looking statements.

*The brand listed is not a trademark of Incyte Corporation. The maker of this brand is not affiliated with and does not endorse Incyte Corporation or its products.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

¹ Siegel R, Naishadham MA, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. Jan- 2012;62:10-29.
² Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-2917.