Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus (ocrelizumab) and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28.
The presentations will offer new insights into the therapy’s mechanisms, safety and effectiveness in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities.
MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease.
The information Genentech plans to present will demonstrate “the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,” Dr. Sandra Horning, the company’s chief medical officer and head of its Global Product Development arm, said in a press release.
Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy’s favorable benefit-risk profile, Genentech added.
Two presentations will cover new ways that doctors can look for signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another is tracking slowly evolving lesions.
Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials (NCT01247324 and NCT01412333), whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients’ disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients’ disease.
Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus’ ability to treat primary progressive MS. It will look at how well Ocrevus slowed the progression of patients’ disability.
Updated information on Ocrevus’ safety — based on open-label extension studies — will be another component of the presentations. So far, researchers have detected no new safety issues.
Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company’s scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute — as opposed to chronic — disease activity.
In addition to “two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,” Horning said.
One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits.
The research team believes the FLOODLIGHT method may be be able to detect subtle changes better. This could make it a better predictor of disease activity and long-term patient outcomes.
In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS.
The U.S. Food and Drug Administration approved Ocrevus in March 2017.