JAK inhibition for solid tumors flops, forcing Incyte to pull the plug on a slate of trials

Incyte CEO Hervé Hoppenot

Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.

Just ahead of its annual numbers release, Incyte reported today that it is slamming the brakes on a range of studies for Jakafi as well as the experimental INCB39110, another JAK1. Already halted on one colon cancer trial failure, Incyte is ending the Phase III pancreatic cancer study, a separate midstage trial in colorectal cancer, a Phase II for breast and lung cancers and a dose-ranging trial for INCB39110 in pancreatic cancer.

Shares of Wilmington, DE-based Incyte ($INCY) plunged 23% on the news of the setback.

Incyte, though, still believes that the drug's impact on the tumor microenvironment, a key target in oncology, is worth studying in combination studies using Merck's checkpoint inhibitor Keytruda, as well as its in-house IDO1 inhibitor and PI3k drug. INCB39110 plus osimertinib, AstraZeneca's next-generation EGFR inhibitor, will also stay in the pipeline.

Back in the summer of 2013, evidence of some success using Jakafi against pancreatic cancer spurred a 33% spike in the biotech's share price, encouraging CEO Hervé Hoppenot to tell reporters some months later that the company's shares were undervalued. At the time the company's shares had risen to about $64 a share. The company's shares were on their way to $130 in the fall of 2015. Today, the price is just north of $57 as a bear market mauls industry shares.

Jakafi is approved to treat myelofibrosis, and Incyte expects the drug will reap more than $800 million in revenue from the treatment this year. 

"The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, 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," said Rich Levy, Incyte's chief drug development officer.

- here's the release