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Another late-stage setback tarnishes Gilead's R&D lustre

Myelofibrosis drug candidate fails to best Incyte/Novartis’ Jakafi in phase III trials

Gilead SciencesGilead has suffered another late-stage pipeline blow, posting lacklustre data for momelotinib – a would-be rival to Incyte/Novartis' blockbuster Jakafi/Jakavi.

The JAK inhibitor was able to show it was non-inferior to Jakafi (ruxolitinib) in the phase III SIMPLIFY-1 trial, which compared the two drugs in the treatment of previously-untreated patients with the bone marrow disorder myelofibrosis.

Around 17% of momelotinib-treated patients and 29% of the Jakafi arm showed a response to therapy, defined as a 35% reduction or more in spleen volume. However, Gilead's drug was less effective than Incyte's drug on secondary endpoints, including total symptom scores.

Critically, the failure to make an impact on symptom scores prevented Gilead from carrying out statistical analysis on three anaemia endpoints, even though it claims "greater improvements" were seen with its drug. A better profile against anaemia was held up as a key differentiator when Gilead licensed momelotinib (CYT387) from YM Bio in 2012.

Those results make it hard to see how Gilead could position momelotinib at the moment as anything more than a 'me too' drug, chasing a product with considerable traction in the market – both Incyte and Novartis have reported growth rates for Jakafi in the region of 50% so far this year.

Jakafi cleared $1bn in sales last year as a treatment for myelofibrosis and another bone marrow disorder called polycythemia vera, and some analysts think it could become a $3bn product at peak despite setbacks in solid tumours such as prostate and colorectal cancer.

Adding to the pressure, in a second study - SIMPLIFY-2 – momelotinib failed to meet its primary endpoint of superiority compared to best-available therapy (BAT) in patients previously treated with Jakafi. However, Gilead pointed out that 88% of patients in the BAT arm were still receiving Jakafi which could have affected the outcome.

Once again, Gilead said there were indications that momelotinib was better on secondary measures such as symptoms scores and anaemia, but as the primary endpoint was missed no statistical analysis was undertaken.

Gilead's chief scientific officer Norbert Bischofberger said the data suggests momelotinib "provides some treatment benefit, including benefit on anaemia-related endpoints," saying the company plans to discuss the results with regulatory authorities "to determine the next steps".

The lacklustre data comes during something of a torrid time for Gilead's R&D team. In the last few months the company has ditched non-alcoholic steatohepatitis (NASH) drug simtuzumab, ulcerative colitis and Crohn's disease antibody GS-5745 and cardiovascular candidate eleclazine for ventricular tachycardia/fibrillation, while halting development of selonsertib in pulmonary arterial hypertension and diabetic kidney disease. The latter remains in testing for NASH and alcoholic hepatitis.

The momelotinib setback is expected to increase pressure on Gilead to carry out a major acquisition to beef up its pipeline.

Article by
Phil Taylor

18th November 2016

From: Research



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