Genentech/Roche announced a higher-dose phase III clinical trial program for Ocrevus and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with Multiple Sclerosis.

Genentech/Roche announced a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS. Ocrevus higher dose Phase IIIb clinical trial program- Halting disease progression is the ultimate aim for patients and physicians, and we are acting on the needs of the MS community, informed by recent data, to optimize the potential of Ocrevus to slow progression for a broad range of patients. Genentech is therefore initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher Ocrevus dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule. This decision was based on analyses from the pivotal RMS and PPMS studies presented at the American Academy of Neurology Annual Meeting 2019, which showed higher Ocrevus exposure was associated with lower B-cell levels and with greater control of disability progression, without impacting safety. At the currently approved 600 mg dose, Ocrevus is the only MS treatment that has demonstrated a consistent and significant impact on slowing disability progression in both RMS and PPMS Phase III studies. The clinical trial program will evaluate the potential benefit of higher dose Ocrevus in further reducing disability progression for people living with both RMS and PPMS. Ocrevus CHIMES trial in minority patients: Genentech recently initiated the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial in African-American and Hispanic- and Latin-Americans with RMS. These patient populations are more likely to experience more relapses and greater disability than Caucasians, yet are vastly underrepresented in most clinical trials.CHIMES is the first prospective trial developed in collaboration with MS patients, patient advocacy groups and investigators to exclusively focus on meeting the needs of minority patients with MS. The findings are expected to improve current understanding of MS disease biology and treatment response, among African-American and Hispanic- and Latin-American patients with MS, with the ultimate goal of increasing high-quality standard of care to traditionally underserved communities and enhancing equality through clinical research.