Genentech Announces Phase 4 Results for Vabysmo in Treating DME Among Underrepresented Populations

Genentech revealed promising 1-year findings from its phase 4 ELEVATUM study for Vabysmo (faricimab-svoa) for diabetic macular edema (DME) in racial and ethnic groups typically underrepresented in clinical trials. Results presented at the American Academy of Ophthalmology (AAO) 2024 annual meeting in Chicago highlight significant visual improvement among 124 US-based participants after 1 year on Vabysmo.

Participants in the open-label, single-arm study, receiving treatment every 8 weeks, showed an average gain of 12.3 letters on an eye chart, roughly equating to two and a half lines of improved vision. Results across key racial and ethnic demographics were comparable. Hispanic and Latino participants, who entered the study with the most severe DME, showed a vision gain of 14.1 letters on average, equivalent to almost 3 lines of improvement. African American and Black participants also demonstrated notable gains, averaging an 11.3-letter improvement.

“Vabysmo has been shown to be an effective first-line treatment for diabetic macular edema, and for the first time, we now have data demonstrating its ability to improve vision in Black, African American, Hispanic, and Latino patients who are disproportionately impacted by this condition," said Jeremiah Brown, MD, an investigator from Retina Consultants of Texas who presented the data. “I felt it was important to take part in this groundbreaking study and hope the findings will inform and improve the care we provide to our patients.”

Consistent with phase 3 YOSEMITE and RHINE DME studies, the ELEVATUM study also demonstrated robust retinal drying in all represented groups, with an average central subfield thickness (CST) reduction of 206.3 microns, a key indicator of decreased retinal swelling.

In developing the ELEVATUM study, Genentech specifically designed enrollment criteria to prioritize representation. Forty-five percent of participants identified as Hispanic or Latino, while 48% were Black or African American. Additionally, participants with a hemoglobin A1c (HbA1c) level up to 12% were eligible for enrollment, higher than the typical threshold of 10% in similar trials, which can inadvertently exclude patients from diverse backgrounds due to varying HbA1c levels across populations.

"Though certain ethnic and racial groups are disproportionately affected by DME, they lag far behind in clinical trial representation," Gregory A. Rippon, MD, Vice President of U.S. Medical Affairs at Genentech, said in a company news release.. "We conducted the ELEVATUM study to address this issue, understanding how underrepresented patient populations respond to treatment with Vabysmo to help deliver better, more equitable care and change how clinical trials are designed in the future.”