First-ever clinical trial exclusively in black and hispanic / latinx people living with multiple sclerosis shows Ocrevus effectively manages disease activity

One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations . Approximately half of all trial participants (n=182) achieved no evidence of disease activity (NEDA) at week 48 (46% of Black participants; 58% of Hispanic / Latinx participants), with over 94% of participants experiencing no relapses (94.7% of Black participants; 95.7% of Hispanic / Latinx participants) during this period.

The safety and efficacy profile demonstrated in the trial was consistent with the large body of clinical evidence from other Ocrevus studies. The results (abstract #P691) were presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis) in Milan.

“We know that Black and Hispanic / Latinx people with MS often experience more severe disease and greater disability compared with their white counterparts. But until now, there has been limited research conducted in these populations,” said Mitzi Joi Williams, M.D., lead trial investigator and founding medical director at Joi Life Wellness MS Center. “The CHIMES trial is a critical step in breaking the cycle of health inequity. The results, for the first time, provide evidence on the benefit of treatment in Black and Hispanic / Latinx people with MS. The study unlocks new insights into the role of social determinants of health in the recruitment and retention of these populations in clinical trials.”

Additional results from the CHIMES trial showed more than 90% of trial participants had no 24-week confirmed disability progression (94.7% of Black participants; 94.2% of Hispanic / Latinx participants) and no T1-Gd+ lesions (95% of Black participants; 97% of Hispanic / Latinx participants). During the trial period, no new or enlarging T2 lesions were observed in about half of Black participants (46%) and more than half of Hispanic / Latinx participants (64%). No new safety signals were reported.

Black and Hispanic / Latinx communities often face socioeconomic and cultural barriers to care that contribute to inequitable differences in health outcomes. Despite making up almost 20% of the MS population, Black and Hispanic / Latinx people living with the disease are vastly underrepresented in clinical research. This has limited the collection of complete and accurate data on the disease biology of MS in these populations. Genentech designed the CHIMES trial in collaboration with people living with MS, advocacy groups and clinical investigators to broaden understanding of MS progression and response to treatment in Black and Hispanic / Latinx populations.

“The CHIMES trial delivers on our intention to lay a strong foundation for more equitable and inclusive care for everyone with MS,” said Quita Highsmith, vice president and chief diversity officer at Genentech. “Research has shown that MS is more common in Black and Hispanic / Latinx people than previously thought, so it is urgent that we understand how to best care for these communities through high-efficacy disease-modifying treatment.”

The CHIMES trial has set a new standard for inclusive clinical research, incorporating proactive measures to overcome circumstantial barriers to recruitment and promote retention among Black and Hispanic / Latinx people with MS. Trial sites, across the U.S., Kenya and Puerto Rico, included academic institutions, hospitals, outpatient clinics, community centers and healthcare provider practices. To facilitate enrollment, trial-related materials were available in multiple languages (English, Spanish and Swahili) and reviewed by an advisory panel to ensure understanding and cultural appropriateness. Trial participants were offered flexible scheduling options; appropriate compensation or reimbursement for loss of earnings, childcare, accommodation, travel and meals; and utilization of ride-sharing companies for transportation. The CHIMES trial has been extended to three years to gather long-term data on MS progression among Black and Hispanic / Latinx populations, with further results anticipated to be available in 2024.

Insights and key learnings from the CHIMES trial design are being applied across other Genentech clinical programs, including the FENopta trial in MS. The trial will serve as a successful model as Genentech continues to progress toward its 2025 D&I commitments to ensure all clinical programs for investigational medicines include population-specific assessments and inclusive research action plans.