Incyte and AstraZeneca Announce New Lung Cancer Clinical Trial Collaboration

Incyte Corporation (Nasdaq: INCY) and AstraZeneca (NYSE: AZN) today announced a new collaboration to evaluate the efficacy and safety of Incyte's Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca's next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso® (osimertinib). The combination will be assessed as a second-line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation. There is increasing evidence that signaling through the JAK-STAT (signal transducer and activator of transcription) pathway could be a contributing factor in resistance to EGFR TKI treatment in patients with EGFR mutation NSCLC. Blocking both JAK and EGFR activity may therefore offer an improved targeted treatment benefit in some patients. Under the terms of the agreement, AstraZeneca and Incyte will collaborate on a Phase 1/2 study, to be conducted by Incyte. The Phase 1 part of the trial is expected to establish a recommended dose regimen for the combination of INCB39110 and Tagrisso while the Phase 2 part of the study will assess the safety and efficacy profile. Results from the study will be used to determine whether further clinical development of this combination is warranted. "The expansion of our research collaboration with AstraZeneca will allow us to further our understanding of these two compounds and explore their potential synergies both of which support our goal of delivering innovative medicines that will benefit patients with cancer or other diseases," said Rich Levy, MD, Chief Drug Development Officer, Incyte. "We look forward to adding to our ongoing clinical research for INCB39110 and exploring the potential of this combination." "We are pleased to be building on our existing relationship with Incyte and exploring a potentially exciting combination for lung cancer patients who have developed a resistance to first generation EGFR inhibitor treatment," said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca. "This collaboration allows us to explore further ways in which Tagrisso, our first-in-class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need, following its accelerated approval in the U.S. and the recent positive CHMP opinion, recommending approval in Europe." This agreement builds on an existing collaboration between the two companies, announced in May 2014, to explore AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).