On October 31, 2017 Incyte Corporation (Nasdaq:INCY) and MedImmune, AstraZeneca’s (NYSE:AZN) global biologics research and development arm, reported the expansion of their clinical collaboration (Press release, Incyte, OCT 31, 2017, View Source;p=RssLanding&cat=news&id=2312658 [SID1234521326]). 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.
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.
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