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Incyte and AstraZeneca to Enter Clinical Trial Collaboration in Early Lung Cancer

Phase 3 trial evaluating Imfinzi and epacadostat in patients with locally-advanced, unresectable non-small cell lung cancer is expected to begin in first-half 2018

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) and MedImmune, AstraZeneca’s (NYSE:AZN) global biologics research and development arm, today announced the expansion of their clinical collaboration. As part of the agreement, the companies will evaluate the efficacy and safety of epacadostat, Incyte’s investigational selective IDO1 enzyme inhibitor, in combination with AstraZeneca’s Imfinzi® (durvalumab), a human monoclonal antibody directed against PD-L1, compared to Imfinzi alone.

“Imfinzi has shown exciting clinical potential in treating patients with locally-advanced lung cancer. We are pleased to build on recent data from the PACIFIC trial to further explore how Imfinzi, in combination with an IDO1 enzyme inhibitor, could provide additional benefit to patients with locally-advanced lung cancer”

The exclusive collaboration for the study population allows the two companies to conduct a Phase 3 trial in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT).

“We are pleased to expand our ongoing clinical collaboration with AstraZeneca and to further explore the potential of epacadostat in patients with locally-advanced unresectable lung cancer,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We look forward to beginning this additional pivotal trial for epacadostat, as we seek to position IDO1 enzyme inhibition as a key component of combination immunotherapy.”

“Imfinzi has shown exciting clinical potential in treating patients with locally-advanced lung cancer. We are pleased to build on recent data from the PACIFIC trial to further explore how Imfinzi, in combination with an IDO1 enzyme inhibitor, could provide additional benefit to patients with locally-advanced lung cancer,” said Sean Bohan, Executive Vice President, Global Medicines Development and Chief Medical officer, AstraZeneca.

The Phase 3 trial, which will be co-funded by the two companies and will be conducted by AstraZeneca, is expected to begin enrolling patients in the first-half of 2018. This agreement builds on an existing clinical collaboration for epacadostat and Imfinzi, announced by both companies in May 2014.

About Locally Advanced (Stage III) NSCLC

Stage III lung cancer is divided into two stages (IIIA and IIIB), which are defined by how much the cancer has spread locally and the possibility of surgery.

Stage III lung cancer represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in seven leading markets1 in 2016. More than half of these patients have tumors that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

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 pembrolizumab or nivolumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 on tumor cells and CD80 on immune cells, countering the tumor’s immune-evading tactics and inducing an immune response.

Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in Immuno-Oncology. Imfinzi is being assessed in Phase 3 trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase 3 trials in NSCLC, SCLC, mUC and HNSCC and in Phase 1/2 trials in hepatocellular carcinoma and hematological malignancies.

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

Follow @Incyte on Twitter at

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit and follow us on Twitter @AstraZeneca.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether and when the planned registrational trials investigating epacadostat with Imfinzi in non-small cell lung cancer or other cancers will commence; whether any of these studies will lead to any products that will be approved for use in humans anywhere; whether these planned collaborations will help improve clinical outcomes for patients; whether and when any data from the Phase 3 clinical trial will be available; and whether IDO1 enzyme inhibition will become a key component of combination immunotherapy.

These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the efficacy or safety of Incyte’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; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; our ability to compete against parties with greater financial or other resources; greater than expected expenses; and such other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including our Form 10-Q for the year ending June 30, 2017. Incyte disclaims any intent or obligation to update these forward-looking statements.

1 France, Germany, Japan, Italy, Spain, UK, US.