Roche trial confirms Vabysmo efficacy in minorities

A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.

Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.

The new data from the ELEVATUM trial are important because African American, Black, Hispanic and Latino peoples are under-represented in clinical trials overall – and are also disproportionately affected by diabetes and at higher risk of developing DME, which is a leading cause of vision loss.

The study in 124 US subjects showed that after one year of treatment with Vabysmo, they could read about two and a half more lines (12.3 letters) on an eye chart, a result that was consistent with the phase 3 studies that supported Vabysmo's approval with mainly White populations.

Moreover, there was little difference between the various racial and ethnic groups included in ELEVATUM, providing evidence that the drug can deliver benefits to patients regardless of their backgrounds. Safety data also revealed no difference between the groups and the population studied in larger trials, with no new safety events recorded.

According to Roche, Hispanics and Latinos were the most likely to have severe DME at the start of the study, and also saw the most benefit – a 14.1-letter increase or around three lines on a chart – while Black subjects saw an 11.3-letter improvement.

"As a clinician who serves patients from these communities that are so often underrepresented in clinical trials, I believed it was important to take part in this ground-breaking study," commented study investigator Jeremiah Brown of Retina Consultants of Texas, who presented the results at the American Academy of Ophthalmology (AAO) in Chicago.

He added that the clinicians behind the study "hope the findings will inform and improve the care we provide to our patients in the clinic daily."

Despite comprising 39% of the American national population, racial and ethnic minority groups tend to suffer more from chronic disorders but make up as little as 2% of the patients involved in biomedical research studies, exposing the pressing need to apply the principles of diversity, equity and inclusion (DEI) in clinical research.

To try to address access barriers, ELEVATUM was conducted at sites that treat a high proportion of African American, Black, Hispanic and Latino populations in urban, rural and community-based locations, widening the net for patient recruitment and helping to overcome obstacles like low health literacy and language barriers.

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