Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘AutoImmune Disease’ category

We’ve noticed for a while now that trials involving immunotherapies have not just standard adverse events reported, but also immune related adverse events (irAEs).  We saw these articulately in combination trials at ASCO earlier this month.

Most of these have involved colitis, hepatitis, pneumonitis and such like. If the signs and symptoms are picked up early through careful monitoring and education, these can be more easily managed and controlled.

What about auto-immune diseases?

Is there a risk of auto-immune disease with long term use usage of checkpoint blockade, especially in situations where patients may be treated until progression, which could be a long time if the patient is one of the lucky ones who get a durable complete response?

In today’s post we take a look at these issues. To learn more, subscribers can log in or you can sign up in the blue box below:

At the 2015 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting Barcelona on Friday, Dr Stephen Hauser (UCSF) presented the data for octrelizumab, an anti-CD20 monoclonal antibody, on behalf of the investigators in the OPERA trial.  This study compared octrelizumab to a standard of care at the time the study started i.e. IFN β-1a (Rebif).

Roche previously announced that ocrelizumab is the first investigational medicine to show positive pivotal study results in both relapsing and primary progressive forms of multiple sclerosis (MS):

  • Ocrelizumab showed superiority to interferon beta-1a (Rebif®) in two identical Phase III studies in people with relapsing multiple sclerosis (MS), the most common form of the disease.
  • Ocrelizumab is the first investigational medicine to show efficacy in people with primary progressive MS in a large Phase III study.

In addition, Dr Montalban presented the latest data for octrelizumab in primary progressive MS versus placebo (there are no approved therapies for this segment) on behalf of the ORATORIO investigators.

Here on BSB we have extensively covered other anti-CD20 monoclonal antibodies such as rituximab, ofatumumab and obinutuzumab in oncology indications specifically associated with hematologic malignancies, so what’s special about this same target and the results in MS with a different chemical entity?

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