Incyte to stop Jakafi pancreatic, colorectal cancer drug trials
pharmafile | February 11, 2016 | News story | Research and Development | Incyte, Jakafi, Jakavi, Novartis, Pancreatic cancer, colorectal cancer
Incyte said today that it is terminating its JANUS clinical trial programme testing blood cancer drug Jakafi in solid tumours after it failed to show sufficient efficacy.
The failure of the Janus 1 Phase III study of Jakafi (ruxolitinib) in combination with Roche’s Xeloda (capecitabine) for the second-line treatment of patients with advanced or metastatic pancreatic cancer led the company to also discontinue the Phase II Janus 2 study of Jakafi and Bayer’s Stivarga (regorafinib) in colorectal cancer.
In addition, Incyte said it would discontinue Phase II studies of the drug in in breast and lung cancer, as well as its dose finding study of JAK1 inhibitor INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer.
The failure of the JANUS III trial is particularly disappointing, as Jakafi had previously showed promise in this indication.
Ongoing studies of ruxolitinib and selective JAK1 inhibitors in haematology indications will continue, Delaware-based Incyte said, as will ongoing studies of selective JAK1 inhibition in solid tumour indications that are based on different hypotheses.
Incyte co-markets Jakafi with Novartis, which promotes the drug outside the US. Incyte promotes the product as Jakavi in the US.
Rich Levy, chief drug development officer of Incyte, says: “The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumours and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomised, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted.
“Unfortunately, the larger studies did not confirm this hypothesis. Moving forward, we remain focused on our strategy to invest in innovation and in our broad development portfolio, as we seek to deliver new medicines to patients with cancer and other diseases.”
Joel Levy
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