- Delaware-based biotech Incyte Corp. on Thursday said it will halt trials of Jakafi in solid tumors, after interim analysis of a phase 3 study in pancreatic cancer failed to show efficacy. Incyte had hoped to expand the indication of Jakafi, which is already approved to treat blood cancers.
- The phase 3 failure follows on the heels of an unsuccessful phase 2 trial of Jakafi in colorectal cancers which Incyte terminated two weeks ago.
- Despite the expansion setbacks, Jakafi has actually done quite well commercially. Revenue jumped 68% to $601 million in 2015 from the year prior in earnings reported Thursday.
Despite the strong commercial success for Jakafi in its currently indication, markets gave more weight to the terminated solid tumor studies, sending Incyte stock tumbling in Thursday trading. Expansion into the solid tumor space was expected to drive future growth for Jakafi sales.
The failure to demonstrate efficacy in solid tumors will increase the pressure on Incyte's other candidates in development. A immunotherapy cancer drug, epacadostat, is expected to begin phase 3 trials in the first half of 2016 for advanced melanoma.
Additionally, Incyte expects new revenue in 2016 from the rheumatoid arthritis drug baricitinib, which it licensed to Eli Lilly. Lilly has submitted the drug for regulatory approval in the U.S. and E.U., triggering $55 million in milestone payments to Incyte. Depending on future regulatory decisions, Incyte will be eligible for further milestone payments as well as royalties on any future sales of baricitinib.
In addition to ending JANUS 1 pancreatic cancer study, Incyte will also halt a related JANUS 2 study, a phase 2 sub-study in colorectal cancer, and two other phase 2 studies in breast and lung cancer.