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Another R&D flop for Incyte, but Jakafi keeps delivering

Jakafi achieved overall response rate of 55% on organ transplant patients who developed GVHD

IncyteIncyte is still trying to recover from the mauling it took after its IDO inhibitor epacadostat for cancer failed earlier this year, and yesterday wrote off another programme in non-Hodgkin’s lymphoma.

The failure was revealed as Incyte set out its R&D stall at an analyst event yesterday, but came amid a series of other updates – including positive news from its REACH1 study of Novartis-partnered Jakafi (ruxolitinib) in acute graft-versus-host disease (GVHD) that sets up regulatory filings for the new indication in the third quarter.

JAK1/JAK2 inhibitor Jakafi – given in combination with corticosteroids – achieved an overall response rate of 55% at day 28 in the trial, which involved patients with donated organ transplants who developed GVHD that would not respond to treatment with corticosteroids alone.

GVHD occurs when donated bone marrow or peripheral stem cells mount an immune response to the recipient, and is a serious and life-threatening condition with first-year mortality of between 25% and 75% depending on its severity.

Two follow-up trials are seeking to extend the use of the drug in GVHD. Novartis is running REACH2 in acute steroid-resistant patients and the two companies co-sponsoring another trial in chronic GVHD – both of which are due to generate results in 2019. Jakafi is marketed by Incyte in the US and by Novartis (as Jakavi) in other markets, for polycythemia vera and myelofibrosis.

Added to that, Incyte also reported some preliminary positive data on a topical formulation of ruxolitinib in atopic dermatitis, suggesting there is plenty more to come from its main revenue provider.

There was also good news to report with Incyte’s fibriblast growth factor receptor (FGFR) antagonist  INCB54828 in bile duct cancer (cholangiocarcinoma) and bladder cancer, with positive phase II data suggesting that the company could be in a position to file for approval in cholangiocarcinoma next year.

Meanwhile, Incyte was quick to point out that the failure of PI3K delta inhibitor INCB50465 in a form of NHL called diffuse large B cell lymphoma (DLBCL) does not affect phase II testing of the drug in other indications, including follicular lymphoma, mantle-cell lymphoma, and marginal-zone-B-cell-lymphoma.

Nevertheless, it’s another bit of bad news for Incyte after the epacadostat failure, what looks likely to be reduced royalties from Eli Lilly for rheumatoid arthritis JAK inhibitor Olumiant (baricitinib) after a less-than-optimal FDA approval, and data suggesting that myelofibrosis patients treated with Jakafi may be at elevated risk of aggressive lymphomas.

22nd June 2018

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