Genentech made approximately 35 presentations at ECTRIMS involving blockbuster MS drug Ocrevus drug, with a focus on relapsing-remitting MS and continuing safety studies.
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Genentech (Roche)’s Ocrevus (ocrelizumab) stole the show at last month’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting, particularly in relapsing-remitting MS (RRMS).
The South San Francisco-based biotech made approximately 35 presentations involving Ocrevus, which is a key driver of Roche’s pharmaceutical division. The drug gained 16% in third-quarter sales, bringing in a total of $1.52 billion Swiss francs.
In an interview with BioSpace, Ashish Pradhan, M.D., executive director and disease area lead, neuroimmunology at Genentech noted that with MS there are two broad treatment strategies.
The first is escalation, which is the use of relatively older but now less effective therapies. This has been shown in head-to-head clinical trials, Pradhan said.
In some cases, physicians may start treatment with those drugs, and then “escalate” to a “highly effective therapy”, such as Ocrevus, if they do not get the response they’re looking for, he noted.
But increasingly, the treatment strategy is to start with the highly effective therapies, “so you hit the disease with the best therapy that you have and try to contain [it] as quickly and as effectively as possible without putting the patient through the process of starting on a less-effective therapy.”
What is important, within the context of some of these clinical studies, is that many patients may have been on less-effective treatments before shifting to newer therapies such as Ocrevus, “which also means that a number of years have passed since their diagnosis,” Pradhan said. This forms part of the basis for Genentech’s Phase IIIb ENSEMBLE trial.
The company presented two-year interim analysis from the open-label study at ECTRIMS. The trial evaluates the effectiveness and safety of the drug in patients with early-stage RRMS over 192 weeks with a follow-up period of at least 48 weeks.
After 96 weeks of treatment with Ocrevus, 77% of patients saw no evidence of disease activity (NEDA), the most standard accepted measure of disability. “They will, of course, be followed for another couple of years,” to determine the final results, Pradhan said.
“What particularly needs to be pointed out is that the EDSS [expanded disability status scale] score, which is a measure of disability, remained stable, or in some instances even showed some improvements in these patients,” he added.
Another study looked at long-term safety across all Ocrevus clinical trials over the last nine years. This safety research has been presented at almost every major MS-related conference since the drug was approved, Pradhan noted.
Genentech collects data from all of the studies as well as from various regulatory databases, and the company’s own Ocrevus website database, “which is the first in the industry,” he said. This particular presentation included approximately 250,000 people from all clinical trials that are ongoing. It looks at two predominant safety outcomes, serious infections and malignancies with a particular focus on female breast cancer.
Genentech has not seen any particular signal for a particular adverse event, Pradhan said, noting that this has been the case in previous instances.
The company plans to continue its vigilance program, as well as long-term studies such as ENSEMBLE, studies in pregnant women and the CHIMES trial in Black and Hispanic Americans.
Interim analysis from CHIMES was also presented at ECTRIMS. One-year data is expected to read out at some point in 2023.
“We demonstrated again that Ocrevus is effective in these populations, which are under-represented in clinical trials,” Pradhan said.
“We’re very proud to say that our commitment to this molecule continues unabated,” Pradhan said of Ocrevus. “It’s a very rich investigation program that is still ongoing and will continue for many years.”
