Incyte has partnered with AstraZeneca ’s biologics research and development division MedImmune to evaluate the combination of epacadostat and Imfinzi (durvalumab) in a Phase III clinical trial to treat non-small cell lung cancer (NSCLC).
Incyte’s epacadostat is an investigational and selective inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, while Imfinzi is a human monoclonal antibody developed to target PD-L1.
The Phase III trial will compare the safety and efficacy of the combination with Imfinzi alone in locally advanced (Stage III) unresectable NSCLC patients who have not progressed after platinum-based chemotherapy given in conjunction with radiation therapy (CRT).
Incyte chief medical officer Steven Stein said: “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.
“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.”
While the trial will be co-funded by both firms, it will be conducted by AstraZeneca and is scheduled to commence patient enrolment in the first half of next year.
AstraZeneca chief medical officer and Global Medicines Development executive vice-president Sean Bohen said: “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.”
Upon evaluation in single-arm studies, epacadostat is reported to have demonstrated results when combined with immune checkpoint inhibitors in patients suffering from NSCLC, melanoma, renal cell carcinoma, bladder cancer and squamous cell carcinoma of the head and neck.