Roche drug ocrelizumab clears final hurdle

Discuss Ocrelizumab, a monoclonal antibody treatment for MS.

Roche drug ocrelizumab clears final hurdle

Postby MSUK » Mon Dec 21, 2015 3:10 am

In September pharmaceutical company Hoffmann–La Roche announced positive results from three large clinical trials of ocrelizumab, an injectable antibody medication that targets B cells, for both relapsing and progressive MS. They found the drug was more effective at treating relapsing MS than interferon beta-1a (Rebif)...Read more - http://www.ms-uk.org/MSnews
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Re: Roche drug ocrelizumab clears final hurdle

Postby CureOrBust » Mon Dec 21, 2015 2:33 pm

I do not understand why they keep saying "The impacts of treatment with ocrelizumab were modest", while even the single result of "Compared to placebo, ocrelizumab also reduced the time required to walk 25 feet by 29%" sounds impressive to me. Just a stab in the dark, but that result alone is probably better than what was seen with Fampyra. I can only guess that they are focusing on the primary end point.

(after post edit)I did a quick superficial look and found this
http://www.pbs.gov.au/info/industry/lis ... fampridine
Post hoc analysis identified a patient group with improvement in walking speed of at least 20%. This translates to an improvement in the time to walk the 25-foot walk test of at least 16.7%.
Taking the 20% as the number (a specifically selected group of responders), the 29% is 145% improvement over Fampyra, a treatment specifically for the T25FW . Using the 16.7% (which I assume are all the participants) it calculates over to a 175% higher response.
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Re: Roche drug ocrelizumab clears final hurdle

Postby MSbro » Tue Dec 22, 2015 5:04 pm

Another monoclonal antibody drug that plays with the immune system. Wonder how many cases of PML this drug will end up giving to MS patients?
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Re: Roche drug ocrelizumab clears final hurdle

Postby cheerleader » Tue Dec 22, 2015 5:12 pm

Since this drug was discontinued for RA and Lupus, must be time for MS....
There were 6 deaths associated with infections in the RA phase III trial.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3911947/
There were 5 deaths associated with serious infections in the Lupus phase III trial.
http://onlinelibrary.wiley.com/store/10 ... 03381232a4

Both of these trials had long-term followup of patients for 4 and 5 years...the MS trials are under a year. It takes time for these serious infections to develop. Is ocrelizumab being rushed for approval for MS?

"Swiss drugmaker Roche AG and Biogen Idec Inc. are discontinuing development of ocrelizumab in patients with rheumatoid arthritis (RA), after an infection-related safety signal was observed in Phase III testing, resulting in the death of some patients.

Results from the program will be made available at a medical forum, the companies said, without divulging the specific type of infection or the number of affected study patients.

Roche and Biogen have said that the infections were serious, some of which were fatal, and others were opportunistic infections.

The FDA had placed a clinical hold on the studies prior to the companies' ultimate decision to stop development in RA. Last year Biogen had stopped its Phase III program of ocrelizumab in lupus patients.


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Re: Roche drug ocrelizumab clears final hurdle

Postby 1eye » Wed Dec 23, 2015 3:21 pm

cheerleader wrote:Is ocrelizumab being rushed for approval for MS?
cheer


Dead people can't spend money. We have to get approval before they start dying. QED.
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Re: Roche drug ocrelizumab clears final hurdle

Postby 1eye » Sun Dec 27, 2015 9:56 am

This is not the final hurdle if you have relapsing-remitting.
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