Roche revealed a comprehensive data portfolio that will be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which will take place from September 24–26 in Barcelona, Spain. A variety of MS patients, including children, pregnant women, and adults with advanced primary progressive MS (PPMS), will be covered in the presentations, including new research on OCREVUS® (ocrelizumab) that supports its effectiveness in halting the progression of disability. Furthermore, Roche will showcase two-year Phase II results demonstrating persistent suppression of disease activity for fenebrutinib, its investigational Bruton’s tyrosine kinase (BTK) inhibitor.
The latest findings support over ten years of clinical and scientific experience with OCREVUS, which has emerged as a key treatment for the main progressive and relapsing types of multiple sclerosis.
We have made significant scientific progress in the treatment of MS and improving outcomes for people living with it, including key life moments such as planning for a family,
With over a decade of efficacy and safety evidence, OCREVUS has transformed the course of MS for people with RMS and PPMS, and the new data further reinforce its role in preventing disability progression. We are also encouraged by the potential of fenebrutinib in redefining future treatment.
Levi Garraway
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OCREVUS Benefits Confirmed in Advanced PPMS and Special Populations
New late-breaking data from the Phase IIIb ORATORIO-HAND study demonstrate the significant benefit of OCREVUS in adults with advanced PPMS, a population with high unmet needs. The study, which included older patients (up to age 65) and those with higher disability levels (Expanded Disability Status Scale [EDSS] score up to 8.0), found that OCREVUS led to a 30% reduction in the risk of 12-week composite confirmed disability progression (cCDP) compared to placebo over a median of 2.75 years (p=0.0007). The benefit was even more pronounced in patients with MRI lesion activity at baseline, who saw a 55% reduction in risk (p<0.0001). OCREVUS was also superior to placebo in delaying overall disability progression and worsening of upper limb function, with a safety profile consistent with previous studies.
Roche will provide a study of more than 5,000 pregnancies from the ocrelizumab pregnancy registry, further confirming its well-established safety profile. The information demonstrates that exposure to OCREVUS during pregnancy does not raise the likelihood of unfavorable pregnancy or baby outcomes. In support of this, one-year findings from the Phase IV MINORE and SOPRANINO studies shown that most babies exposed to OCREVUS during pregnancy or breastfeeding retained normal B-cell counts and developed protective antibody responses to typical childhood immunizations.
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The first comparable data from a pediatric-onset MS trial will also be presented by Roche. Results comparing OCREVUS, a high-efficacy disease-modifying therapy (DMT), with the authorized medication fingolimod in children with relapsing-remitting multiple sclerosis (RRMS) aged 10–17 will be presented in the groundbreaking Phase III OPERETTA 2 research.
Furthermore, the Phase III OCARINA II study’s final two-year findings verify that the OCREVUS subcutaneous injection maintains near-complete suppression of relapses, brain lesions, and disability progression while offering a consistent benefit-risk profile to the intravenous (IV) infusion.
Fenebrutinib Shows Sustained Efficacy at Two Years
Roche will share two-year open-label extension data from the Phase II FENopta study of fenebrutinib from its MS portfolio. According to the findings, at 96 weeks, individuals with relapse multiple sclerosis (RMS) receiving treatment with the experimental oral BTK inhibitor continued to exhibit almost total suppression of disease activity. Important conclusions include:
- A low annualized relapse rate (ARR) of 0.06.
- No disability progression as measured by EDSS.
- Zero new T1 gadolinium-enhancing (T1−Gd+) lesions were detected on MRI scans.
- Neurofilament light chain (NfL), a biomarker for nerve damage, was reduced to levels seen in healthy donors and sustained through the second year.
These encouraging findings come ahead of the crucial readouts from three ongoing Phase III trials: FENtrepid in PPMS, FENhance I and II in RMS. By the end of this year, preliminary results from the FENtrepid study, which compares fenebrutinib to OCREVUS.
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About OCREVUS® (ocrelizumab)
A humanized monoclonal antibody called OCREVUS targets CD20-positive B cells, which are thought to be a major contributor to the nerve and myelin destruction that characterizes multiple sclerosis. It is the only treatment authorized for both PPMS and RMS, including RRMS and active SPMS. It is given as a subcutaneous injection or intravenous infusion every six months.
About fenebrutinib
Fenebrutinib is a reversible, non-covalent, oral BTK inhibitor being studied for its ability to cross the blood-brain barrier and enter the central nervous system. Fenebrutinib may be able to treat inflammation and the progression of disability in multiple sclerosis by preventing the activation of both B cells and microglia.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
