AstraZeneca plans new pivotal lung cancer trial

Pharmaceutical business AstraZeneca and its biologics research arm have announced expansion of their clinical collaboration with global pharmaceutical company.

The companies will evaluate the efficacy and safety of epacadostat, Incyte’s investigational selective IDO1 enzyme inhibitor – image courtesy of AstraZeneca

AstraZeneca and MedImmune, its global biologics research and development arm announced the expansion of their clinical collaboration with Incyte Corporation.

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 for the two companies to conduct a Phase III 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).

Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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 IDO inhibitor could provide additional benefit to patients with locally-advanced lung cancer.”

Steven Stein, MD, chief medical officer, Incyte, 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 an additional pivotal trial for epacadostat, as we seek to position IDO1 enzyme inhibition as a key component of combination immunotherapy.”

The Phase III 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 Imfinzi and epacadostat announced by both companies in May 2014.