A planned interim analysis of Janus 1 phase 3 study showed that ruxolitinib plus capecitabine did not demonstrate a sufficient level of efficacy to warrant continuation.
The primary objective of the trial was to evaluate and compare the overall survival of patients treated with ruxolitinib in combination with capecitabine versus capecitabine alone.
Secondary objectives identified and compared the efficacy of the two treatment groups with respect to progression-free survival, overall tumor response and duration of response, as well as safety and tolerability.
Based on these data and the interim analysis of the phase 2 sub-study of ruxolitinib or placebo in combination with regorafinib in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all studies in solid tumors, including phase 2 trials in breast and lung cancer.
It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
Incyte said it will continue ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications and selective JAK1 inhibition in solid tumor indications that are based on different hypotheses.
The potential impact of JAK1 inhibition on enahancing the benefit of targeted therapies will be investigated through a phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s EGFR inhibitor.
The US Food and Drug Administration approved ruxolitinib (Jakafi) to treat people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is also indicated to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.