EXCLUSIVE: Genentech/Roche Interview with MS News Today on Promising MS Therapy Ocrelizumab #ECTRIMS 2015

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Dr. Peter Chin, a renowned neurologist and Principal Medical Director of Global Neuroscience Development at Genentech, a leading biotechnology company and member of the Roche Group, participated in an exclusive interview with Multiple Sclerosis News Today correspondent Dr. Ana de Barros on the company’s promising multiple sclerosis (MS) therapy ocrelizumab. The new, experimental therapy has made headlines this week after the company presented positive data in the treatment of both Relapsing and Primary Progressive Multiple Sclerosis.

The interview was conducted on Saturday at the end of the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held this year in Barcelona, Spain (October 7 to 10, 2015). Topics that are important to MS patients and the healthcare community were addressed, including adverse side effects, prospects in terms of release and price, and plans for worldwide approval of ocrelizumab. In addition, two questions selected from readers of MS News Today concerning secondary progressive MS and primary progressive MS were addressed.

Listen to full audio of the exclusive interview below:

Roche/Genentech’s experimental MS therapy was discussed several times throughout ECTRIMS 2015, including during Parallel Session 10, entitled “Update on therapies,” where Dr. Stephen Hauser from the University of California, San Francisco presented his work on “Efficacy and safety of ocrelizumab in relapsing multiple sclerosis — results of the interferon-beta-1a-controlled, double-blind, Phase III OPERA I and II studies.

Ocrelizumab is a recombinant humanized monoclonal antibody against immune B cells that express CD20 proteins at their surface. These cells are thought to be a key contributor to the myelin and neuron damage that leads to motor function impairment, irreversible neurological disability and paralysis in MS patients.

“B cells can contribute to the pathophysiology of MS,” explained Dr. Hauser during his presentation, “targeting CD20-B cells may preserve B cell reconstitution and long-term immune memory.”

Ocrelizumab’s safety and efficacy was assessed in three major Phase 3 clinical trials: OPERA I, OPERA II, and ORATORIO. In his presentation, Dr. Hauser, chair of the Scientific Steering Committee of the OPERA studies, provided data on the trials’ results where ocrelizumab was compared to interferon (IFN)-beta-1a, a well-established MS therapy, in patients with relapsing forms of MS over a treatment period of 96 weeks.

Dr. Hauser showed that ocrelizumab was effective in treating relapsing MS, having a favorable safety profile over 96 weeks. When compared to IFN-beta-1a, ocrelizumab significantly reduced the annualized relapse rate, the 12- and 24-week confirmed disease progression, and existing, new and/or enlarging brain lesions. Furthermore, ocrelizumab also reduced brain volume loss by 23.5% in relapsing MS patients in comparison to IFN-beta-1a therapy, and increased the proportion of patients who did had no evidence of disease activity (NEDA).

“OPERA I and OPERA II showed that targeting CD20-B cells with ocrelizumab is a potential therapeutic approach in relapsing MS,” said Dr. Hauser.

In terms of safety, Dr. Hauser reported that the most adverse events were infusion-related reactions (especially in the first infusions). In the combined cohort of patients who finished the trials (more than 1,000), six malignancies were reported and three deaths occurred, two of them by suicide.

On October 10, a Parallel Session entitled “Late Breaking News” took place at ECTRIMS, with Prof. Xavier Montalban from the Hospital Vall d’Hebron University, Barcelona, Spain, presenting his work under the title “Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis — results of the placebo-controlled, double-blind, Phase III ORATORIO study.

The ORATORIO trial assessed the efficacy and safety of ocrelizumab in patients with primary progressive MS (PPMS) compared to a placebo. Prof. Montalban showed that 80% of the patients under ocrelizumab treatment completed the study, having achieved its primary endpoint, a significant reduction in 12-week confirmed disability progression compared to the placebo group (by 24%). Furthermore, patients treated with ocrelizumab were found to have a 25% reduction in the risk of confirmed disability progression at 24-weeks, and a significant reduction of 29% in the progression rate of walking time. Ocrelizumab was also found to significantly reduce brain lesions by 3.4% in comparison to a placebo therapy, and to promote a reduction in whole brain volume loss by 17.5% (week 24 to week 120).

In terms of safety, Prof. Montalban reported, “Throughout the mean treatment duration of approximately 3 years, ocrelizumab showed a favorable safety profile; overall, the proportion of patients experiencing adverse events and serious adverse events associated with ocrelizumab, including serious infections, was similar to placebo”. Five deaths were reported, one in the placebo group and four on the ocrelizumab group, linked to conditions like pneumonia, pulmonary embolism and pancreas carcinoma. Complete safety analysis is currently underway, including investigation of any malignancies.

Prof. Montalban concluded, “ORATORIO data show that B cells may play a role in PPMS pathophysiology,” and that ocrelizumab significantly reduced the confirmed disability progression and brain volume loss in PPMS patients.

Ocrelizumab is now considered the first investigational drug to significantly reduce disability progression in patients with relapsing MS and PPMS. This is especially important for patients with PPMS as there are no approved treatments for this form of the disease.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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  1. Mary Trimarco says:

    After reading the above article would I be right in thinking that Ocrelizumab is not for Secondary progressive MS?

    • Michael Nace says:

      Hi Mary. Yes, for now, Genentech/Roche has not tested Ocrelizumab in SPMS. If you listen to the interview, we did ask Dr. Chin about it, but at present they don’t have any data on how the drug can work in SPMS yet. We’ll have to wait and see what they do with the indication in the future.

  2. Liv Skartveit says:

    I wonder if there in these studies only are included patients newly diagnosed with MS to be sure they have not reached the secondary progressive phase?

    • Michael Nace says:

      Hi Susan. Ocrelizumab is still only an experimental therapy — the FDA hasn’t approved it yet, but Roche plans on beginning the process of getting it approved as a next step. The reason why people with PPMS are excited about Ocrelizumab is because in the latest clinical trial, it was effective in treating that form of the disease. If Ocrelizumab is approved, it will be the first MS therapy that can directly treat PPMS. But it still needs to be approved.

    • Patricia Silva, PhDPatricia Silva, PhD says:

      Hi Susan, so far there are no reports of PML cases on these Ocrelizumab studies, however, a complete analysis of the data in terms of safety is still underway.

  3. Pina Spadaro. says:

    Hola: Yo creo que no existe empp o emsp me parece por mi experiencia personal que cuando sientes los brotes y no remiten a tiempo comienza la inflamación de (SNC) por consiguiente se va instalando la discapacidad.
    Tengo 17 años de diagnosticada, 13 sin rastros de em,(Totalmente normal) me sentía cada vez mejor con el Interferón beta-1a, solo 4 de em definida,
    Espero poder tener acceso al Ocrelizumab es mi única esperanza por el momento.
    Gracias por permitirme opinar.

  4. Nancy Hale says:

    Thanks to my supportive neurologist, I am one of the patients in the OPERA II study of ocrelizumab for the past 4 years. I was actually assigned randomly to Rebif for the first 2 years of the study. As follow up, I then received infusions of ocrelizumab every 6 months.

    Yes, I was newly diagnosed with MS at age 51 when I joined the study as a patient.

    The first 2 years were fraught with subcutaneous injections 3 times weekly with severe flu like symptoms afterwards for several hours. Since the study was double blind double dummy, I only know now that I was randomly assigned to the Rebif group for my first 2 years.

    The decrease in pain and disability has been amazing within the past 2 years while using ocrelizumab. I feel like a whole new person. My disability score has improved, my quality of life is so much better, and my overall outlook on life is once again positive. I’ve noticed few side effects especially compared to Rebif. I feel so blessed to have the opportunity to participate in this groundbreaking medical advancement for us MSers!

    My hope is for ocrelizumab to be available worldwide as soon as possible!

    • betty fertig says:

      i am a 64 year old who has had ppms for 34 years. i pray that ocrelizumab will be approved by the FDA SOON and that the cost is not unreasonable. i have missed doing so much with my daughters and grandkids. this drug has given me so much hope.

      • Amanda Galligan says:

        I am 55. Have been battling PPMS nearly 9 years. In a wheelchair can stand tho.
        Please hurry with ocrelizumab approval. So many lives depend on it. I can’t take much more.

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