Monday, 11 July 2011

Alemtuzumab (Lemtrada) misses a goal in study

A press release on the headline results of the Alemtuzumab vs. Interferon-beta-1a trial:

"Sanofi said Lemtrada worked better than an older drug, Rebif, in preventing relapses, as patients treated with Lemtrada were 55 percent less likely to experience a relapse in symptoms. However, the drug did not prevent their multiple sclerosis from becoming disabling, as it had in previous studies."

"I was expecting better; it shows you that phase 2 studies don't always translate into phase 3 results. I suspect this occurred because the MS'ers in the current or phase 3 study, were not as active as those in the phase 2 study. Are you disappointed?"

Data source: Forbes press release

CoI: Multiple

13 comments:

  1. Extremely disappointed and disheartened.
    By 'not as active' do you mean that they had more advanced disease?

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  2. The second phase three study for alemtuzumab involves patients who have relapsed on Interferon i.e. more active so I wonder whether the results for that trial will be more encouraging

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  3. (Cont'd from previous post) Surely it is unlikely alemtuzumab would have been licensed as a first line therapy in any case - its side effect profile is more questionable than Interferons and Copaxone.

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  4. You have to hate MS - every time something looks promising it always ends up the same. Remember Aimspro! 4-5 years ago it was Tysabri (now ever increasing numbers of PML). Then Lamotrigine for SPMS. Oral Cladbrine has bitten the dust. Watch out for the unforeseen side effects of Fingolimod. What's the betting that anti-lingo anti-body will fail to deliver!

    I'm coming to the conclusion that some diseases aren't mean't to be cured. We obviously did something very bad in an earlier life!

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  5. "it shows you that phase 2 studies don't always translate into phase 3 results."

    But I bet it's always positive to negative!

    This wa sthe great white hope for RRMS patients the Phase 11 trial results looked every impressive and the PIs claimed that many saw a reduction in disability!

    I can understand that the relapse rate reduction might not be as good when the traillists are very early diagnosed. iws hoping that if given really early that Alemtuzumab might shut the disease down.

    Having said all that, I know three on Camms223 who have done very well. No relapses after 6-7 years and stable EDSS score.

    But if these results do not improve with time i.e. looking in 2-3 years at the difference between the groups, then I'm afraid that MS researchers have got to accept that they will have to shift form the focus on the immune system as the main driver of the disease. Even the most powerful immune suppressing drugs i.e. Campath, do not appear to have a susbtanital impact on this disease.

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  6. Unfortunately, the trials system is a farce.

    Some drugs e.g. oral cladribine are trialled against placebo. Other e.g. Campath are trialled against a licensed therapy (Rebif). The Phase II trial of Campath (which I was in) was for those with active MS (those I met had had the disease for 3-5 years). And you know if you got Rebif (3 injections a day) or Campath (5 day infusion one year and 3 day infusion the next year).

    Minocycline (cheap) loked promising, but the trail combines it with Copaxone (so never goign to see how good Minocyclien was on its own). Same with estriol trial.

    So Phase 11 and Phase III Camapth trials can't be compared - newly diagnose and those with MS for 3-5 years. It's know that most relapases occur in the early stages so trialling later on will always look better.

    I'm very disappointed. mainly with the way that reseachers are allowed to over-hype the treatments. These Phase II Camapth results look very similar to Fingolimod. So the decision on whether you go for Campath or Finlgomo will not come down to efficacy, but which has the greater risks (ITP v skin cancer). What a choice for peoel who are already ill!

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  7. Will the last MS turn out the light.

    In Dad's Army speake "we're domed' we're dommed".

    20 years in the making and Alemtuzumab fail to deliver (as all other MS treatments before). You'd think that for the price of Graves' disease or ITP you'd get stable EDSS!

    At the MS Research Day the impression I got was that those with early MS in the future would be given Alemtuzumab to give long term remission.

    SO much promise as ever. If Alemtuzumab can't stop disability in the recently diagnosed then it's not the wonder drug many thought.

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  8. Re: "By 'not as active' do you mean that they had more advanced disease?"

    No they had disease for a longer duration and therefore less likely to have relapses.

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  9. Re "Surely it is unlikely alemtuzumab would have been licensed as a first line therapy in any case - its side effect profile is more questionable than Interferons and Copaxone."

    The current trials are being done in early disease, a phase in the disease is most responsive to treatment. The longer you wait to treat MS to less likely you are to impact on the progressive phase of the disease. Alemtuzumab will have its greatest impact when used as soon as possible after the onset of the disease.

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  10. Re: "These Phase III Camapth results look very similar to Fingolimod. So the decision on whether you go for Campath or Fingolimod will not come down to efficacy, but which has the greater risks (ITP v skin cancer). What a choice for peoel who are already ill!"

    Fingolimod was against a placebo and Alemtuzumab is against an active comparator; Alemtuzumab punches above Fingolimod in terms of effectiveness on relapse rate. The serious sides effects are relatively uncommon and are manageable. ITP is treatable and skin cancers can be picked-up with screening and managed accordingly.

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  11. Re: "20 years in the making and Alemtuzumab fail to deliver (as all other MS treatments before)"

    Not true this efficacy is against a standard first line therapy. It remains very effective!

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  12. Re: "But I bet it's always positive to negative!"

    Not correct. Natalizumab improved from phase 2 to 3 and so has BG12 (dimethyl fumarate).

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  13. "You have to hate MS - every time something looks promising it always ends up the same."

    Please note that the trial is positive; it is not a negative study. The only issue is that the relapse reduction was less in the phase 3 study compared to the phase 2 study.

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