Here are the Trial Results from the phase III RRMS trials
The results compare the effect of ocrelizumab to beta interferon. The results of the two trials are comparable and show superiority to beta interferon and the results are comparable to that found with alemtuzumab. However, there were no reported cases of secondary autoimmunity andno reported cases (yet) of PML. There very impressive in terms of efficacy and seemingly safer than other highly effective DMT.
The annualized relapse rate was abount 0.15 and NEDA-3 was 47% which is comparable to that reported with oral cladribine. Also similar to or should I say seemingly worse than cladribine was the occurance of malignancies in the PPMS trial
Here are the Ocrelizumab in PPMS trial
So if we look at the malignacies it was 11 with ocrelizumab verses 2 in Placebo group and one can argue that the basal cell cancinomas aren’t malignancies moving it to 8 to 1. Now there are more people taking ocrelizumab (double) than placebo, but if we remember that oral cladribine was rejected by the regulators with comparable number of people on drug on what turned out to be only 3 malignacies on cladrinine verses 0 on placebo. 8 to 1 is somewhat more. In fact it in the placebo group it was adeno carcinoma in situ which is not a malignancy and so it 8 to 0. There was only one trial with movectro and the mud stuck, but serves to show how one trial can skew the view. Will the same mud be thrown? or will the additional trials pacify the nay sayers?
This is because when we look at the RRMS studies there were only 4 malignacies in the ocrelizumab group n =>800 and 2 in the control group (n=>800). Suggesting that the PPMS results were a fluke. However 6 breast cancers (Ocrelizumab in 1100-1200 verses 0 in the control arms (n=1000) may raise some eyebrows.
However it is clear that PPMS is not immovable and it is the beginning.