New data from Roche’s study on the use of Ocrevus to treat patients with primary and secondary progressive multiple sclerosis demonstrated positive outcomes.
Smith Collection/Gado/Getty Images
New data from Roche‘s study on the use of Ocrevus (ocrelizumab) to treat patients with primary and secondary progressive multiple sclerosis demonstrated positive outcomes in what could be a milestone advancement for people living with the disease.
Interim analysis from the Phase IIIb CONSONANCE trial showed very low levels of disease progression in both SPMS and PPMS patient groups when they were evaluated one year after the study started. This trial is the first of its kind to evaluate Ocrevus’ effect in primary and secondary PMS patients.
A year after the CONSONANCE trial commenced, researchers found that 75% of the 629 participants who received Ocrevus showed no evidence of progression, or NEP, as measured by an increase in one’s Expanded Disability Status score sustained for a minimum of 24 weeks.
Roche’s scientists also saw below 20% in another key metric: worsening of performance based on the nine-hole peg test (9-HPT) and timed 25-foot walk (T25-FW). NEP is a composite endpoint and does not reflect evidence of worsening physical disability.
In addition, 59% of the patients had no evidence of progression or active disease or NEPAD. This translates to NEP plus no protocol-defined relapses, new and/or enlarging T2 lesions or T1 gadolinium-enhancing lesions for more than a year. NEPAD is another composite endpoint, reflecting no evidence of clinical or MRI disease activity or physical disability worsening issues.
With these data, Roche is committed to continuing studying Ocrevus for another four years in a longer-term trial, with a target of 900 patients in 26 countries.
“We are encouraged by the low levels of disability progression and cognitive decline in OCREVUS-treated patients seen across the complete spectrum of progressive MS for the first time, since SPMS and PPMS often bring a substantial quality of life burden,” commented Levi Garraway, M.D, Ph.D., the chief medical officer and head of global product development at Roche, in a statement.
The Ocrevus results are just one of two wins announced by Roche in the past week. The second one is the U.S. Food and Drug Administration‘s acceptance of the company’s supplemental Biologics License Application for Actemra/RoActemra (tocilizumab), which is intended to treat hospitalized adults with COVID-19. Roche was also granted Priority Review.
The drug has been effective in treating COVID-19 across four trials covering over 5,500 hospitalized participants: EMPACTA, REMDACTA, COVACTA and RECOVERY. All studies demonstrated Actemra/RoActemra’s capacity to improve the outcomes of patients already receiving corticosteroids and needing mechanical ventilation, extracorporeal membrane ventilation or supplemental oxygen. The FDA is expected to approve the drug by the second half of 2022.
Actemra/RoActemra won its Emergency Use Authorization in June 2021. It is approved in 16 countries for defined patients hospitalized with severe or critical COVID-19. The World Health Organization also allowed patients in low- and middle-income countries access to the drug in February.
The encouraging news follows the failed SKYSCRAPER-02 trial on tiragolumab for extensive-stage small cell lung cancer in the prior week.
