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ASH meeting hears of progress with myelofibrosis drugs

New studies suggest momentum is for use of Janus kinase (JAK) inhibitors

ASH 2012 meeting 

New studies presented at the American Society of Hematology (ASH) suggest momentum is building behind the use of Janus kinase (JAK) inhibitors in the blood cancer myelofibrosis.

Incyte Corp and partner Novartis are due to report data from several studies of their first-in-class drug Jakafi/Jakavi (ruxolitinib) later today, but in the meantime clinical results have also been presented on rival JAK inhibitors.

For example, a phase II trial of Sanofi's selective JAK2 inhibitor SAR302503 showed the drug reduced spleen size and improved symptoms in myelofibrosis patients when dosed at either 400mg or 500mg once-daily.

Spleen volume was reduced by 30 to 42 per cent, depending on the dose used, with 64 per cent of patients on 500mg SAR302503 experiencing a 35 per cent or more reduction in spleen volume. Improvements in constitutional symptoms ranged from 44 to 50 per cent, while the most common side effects were anaemia and low platelet counts.

SAR302523 is a selective JAK2 inhibitor that recently advanced into phase III testing in primary and secondary myelofibrosis, a malignancy which Sanofi says has "unmet medical needs" despite the availability of Jakafi.

Incyte's drug has been available to treat myelofibrosis in the US since November 2011 and looks set to achieve sales of around $300m in its first 12 months on the market. Novartis is about to start rolling out the drug in Europe following approval there in August.

Jakafi is a combined JAK1 and JAK2 inhibitor, and Sanofi maintains that there may be benefits in selectively targeting only the JAK2 enzyme as this form is most commonly found in myeloproliferative cancers.

Another company developing JAK inhibitor for myelofibrosis - YM Biosciences - reported phase I/II data at ASH for its candidate CYT387. 

The trial of the combined JAK1/JAK2 inhibitor involved 166 patients with myelofibrosis and showed a 37 per cent spleen response rate with the drug, with the percentage of patients needing blood transfusions dropping from 44 per cent at enrolment to less than 10 per cent after 40 weeks' treatment.

YM Biosciences has suggested CYT387 may be less likely to exacerbate anaemia than Jakafi, although this requires conformation in further studies.

Meanwhile, Incyte and Novartis are due to present long-term outcome data showing durable reductions in spleen volume, improvements in quality of life and importantly the first indications of a survival benefit for Jakafi in myelofibrosis later today.

The data - from the COMFORT I and II trials of the drug - could lead to an acceleration in take-up as new data on survival and safety should encourage use beyond its current role in advanced-stage patients with high symptom burden.

The absentee at ASH this year among the myelofibrosis candidates was Cell Therapeutics Inc's recently-licensed pacritinib, which like Sanofi's drug is a selective JAK2 inhibitor and has also just started phase III testing. CTI picked up pacritinib from Singapore's S*Bio in a $30m deal in August.

10th December 2012

From: Research



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