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New data backs Merck’s segue into MS with BTK inhibitor

Patients had fewer lesions on evobrutinib than placebo


BTK inhibitors are already establishing themselves as important new drugs in cancer, but Merck KGaA has the first data suggesting they could also play a role in neurological disorder multiple sclerosis.

The German drugmaker has reported new phase 2 results with its oral BTK inhibitor evobrutinib in relapsing MS, which show the drug can cause rapid reductions in lesions in the brain over a 48-week treatment period.

MS is caused by an autoimmune attack that results in the loss of the protective myelin sheath around neurons in the central nervous system, causing damage and scarring that can be detected using magnetic resonance imaging (MRI).

24-week data with evobrutinib were first reported last year and have just been published in the New England Journal of Medicine, which show that patients given 75mg of evobrutinib once daily had significantly fewer lesions during weeks 12 through 24 than those on placebo.

There was however no significant difference with placebo for either the 25mg once-daily or 75mg twice-daily dose of evobrutinib, or indeed in the relapse rate or disability progression at any dose, painting a mixed picture of the outcome.

The trial investigators write that additional studies are needed to see if this initial data translates to a meaningful clinical effect in MS.

The new 48-week data, presented at the American Academy of Neurology (AAN) meeting in Philadelphia last week, seems to firm up the evidence for a beneficial effect of the drug.

In the update, Merck notes that with both 75mg doses there were rapid reductions in the number lesions in the first 12 weeks of treatment, and that those reductions were maintained out to 48 weeks.

Both once-daily and twice-daily doses of the BTK inhibitor “significantly reduced the total number of […] lesions at week 12, 16, 20 and 24 versus placebo”, with a dose response observed, according to the abstract from the trial.

The BTK inhibitor is thought to exert its effects in MS by inhibiting the activity of B cells, which are involved in the autoimmune response to myelin. That mechanism also forms the basis of Merck’s testing of evobrutinib in rheumatoid arthritis and systemic lupus erythematosus (SLE), also at the phase 2 stage.

Merck isn’t directing its BTK inhibitor at oncology, where AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib) is approved for multiple blood cancers and is leading the market.

There was positive news for AstraZeneca on that front last week however, when it announced that a phase 3 trial of its challenger Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL) would be halted early after positive results.

The ASCEND study is the first of two phase 3 CLL trials with Calquence expected to read out in 2019, and approval in this indication would expand the market for the drug, which is already used for relapsed or refractory mantle cell lymphoma (MCL).

13th May 2019


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