Incyte announces decision to discontinue JANUS Studies of ruxolitinib (Jakavi/Jakafi) plus capecitabine in patients with advanced or metastatic pancreatic cancer.- Incyte + Novartis

Incyte Corporation (announced its decision to discontinue the Phase III study (JANUS 1) of ruxolitinib or placebo in combination with capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer. The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

Following these results, and the previously announced interim analysis of the Phase II sub-study of ruxolitinib or placebo in combination with regorafinib in patients with metastatic colorectal cancer and high C-reactive protein (CRP), ongoing Incyte-sponsored trials of ruxolitinib in solid tumors will be discontinued, including the Phase III JANUS 2 study in pancreatic cancer, the Phase II sub-study in patients with metastatic colorectal cancer and low CRP and the Phase II studies in breast and lung cancer. Incyte’s dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer, will also be discontinued. Incyte will work with investigators to appropriately conclude these studies in a manner consistent with the best interest of each patient. Data from these studies will be analyzed and shared with the scientific community over the coming months.

Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of studies evaluating INCB39110 in combination with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) to assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential impact of JAK1 inhibition on improving the benefit of targeted therapies will be investigated via a Phase 1/II study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.