The Group Medical Director of Neuroscience at Genentech discussed the shorter, 2-hour infusion time for ocrelizumab and how it might impact multiple sclerosis care as a whole.
Kathleen Hawker, MD
This week, Genentech announced that its new 2-hour ocrelizumab (Ocrevus) infusion—administered twice yearly—for those with relapsing or primary progressive multiple sclerosis (MS), was accepted for review by both the FDA and EMA. The supplemental biologics license application (sBLA) is supported by data from the ENSEMBLE PLUS study, a double-blind, prospective substudy to the open-label, single-arm, phase 3b ENSEMBLE (NCT03085810) trial.
The data suggest that the 2-hour infusion time has a comparable frequency and severity of infusion-related reactions (IRRs) to the currently approved 3.5-hour infusion time in those with relapsing-remitting MS, and Genentech stated that detailed data from the study will be presented at the earliest opportunity. Decisions on the new infusion time are expected by the end of 2020.
To find out more about what the neurology community needs to know about this quickened infusion of ocrelizumab and how it might impact MS care as a whole, NeurologyLive inquired with Genentech’s Group Medical Director of Neuroscience, Kathleen Hawker, MD.
Kathleen Hawker, MD: Genentech is constantly striving to improve the patient and healthcare provider experience with Ocrevus. If approved, a shorter Ocrevus infusion time will further improve the treatment experience and convenience for people with relapsing or primary progressive MS, while also increasing capacity in healthcare systems as the time people will need to spend at treatment centers will be reduced.
While the ENSEMBLE PLUS study was initiated prior to the COVID-19 pandemic, the pandemic has highlighted the need for improved efficiencies in healthcare systems. With the convenience of a twice-yearly dosing schedule, we hope a shorter infusion time will further benefit people with MS and reduce the burden on infusion sites given capacity issues.
With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many people with MS and their physicians, and we are constantly striving to improve the treatment experience. The frequency of administration is highly important to patients and healthcare providers and with a shorter infusion time, we hope it will provide convenience and efficiencies for both patients and healthcare providers.
Data from the randomized, double-blind ENSEMBLE PLUS study, showed consistent safety relative to the currently approved Ocrevus dosing regimen. Results from the ENSEMBLE PLUS study showed comparable frequency and severity of infusion-related reactions (IRR) for a targeted Ocrevus infusion time of approximately two-hours vs. the currently approved approximately 3.5-hour time in patients with relapsing-remitting MS. No patients discontinued the study due to an IRR and no new safety signals were detected. Detailed data will be presented at the earliest opportunity, likely during a virtual medical conference this year.
Transcript edited for clarity.
US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time [press release]. Basel, Switzerland: Genentech; Published April 20, 2020. Accessed April 20, 2020. globenewswire.com/news-release/2020/04/20/2018330/0/en/US-FDA-and-EMA-accept-applications-for-Roche-s-OCREVUS-ocrelizumab-shorter-2-hour-infusion-time.html