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Genentech’s Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study

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Genentech announced positive one-year results from the ELEVATUM study, evaluating Vabysmo for treating diabetic macular edema (DME) in underrepresented racial and ethnic groups. The study showed:

  • Participants could read an additional 12.3 letters on average after one year of treatment
  • Hispanic and Latino participants gained an average of 14.1 letters
  • African American and Black participants gained an average of 11.3 letters
  • A decrease of 206.3 microns in central subfield thickness, indicating retinal drying

The study included 45% Hispanic or Latino and 48% Black or African American participants. Results were consistent with previous Phase III studies, and Vabysmo was well-tolerated with no new safety events identified. This first-of-its-kind study aims to address health disparities and improve clinical trial representation for populations disproportionately affected by DME.

Genentech ha annunciato risultati positivi dopo un anno dallo studio ELEVATUM, che ha valutato Vabysmo per il trattamento dell'edema maculare diabetico (DME) in gruppi razziali ed etnici sotto-rappresentati. Lo studio ha mostrato:

  • I partecipanti sono riusciti a leggere in media 12,3 lettere in più dopo un anno di trattamento
  • I partecipanti ispanici e latini hanno guadagnato in media 14,1 lettere
  • I partecipanti afroamericani e neri hanno guadagnato in media 11,3 lettere
  • Una diminuzione di 206,3 micron nello spessore del campo centrale, che indica un assottigliamento della retina

Lo studio ha incluso il 45% di partecipanti ispanici o latini e il 48% di partecipanti neri o afroamericani. I risultati sono stati coerenti con studi precedenti di Fase III e Vabysmo è stato ben tollerato, senza eventi di sicurezza nuovi identificati. Questo studio, il primo del suo genere, mira a affrontare le disparità sanitarie e migliorare la rappresentanza nei trial clinici per le popolazioni sproporzionatamente colpite dal DME.

Genentech anunció resultados positivos después de un año del estudio ELEVATUM, que evaluó Vabysmo para tratar el edema macular diabético (DME) en grupos raciales y étnicos subrepresentados. El estudio mostró:

  • Los participantes pudieron leer un promedio de 12,3 letras adicionales después de un año de tratamiento
  • Los participantes hispanos y latinos ganaron un promedio de 14,1 letras
  • Los participantes afroamericanos y negros ganaron un promedio de 11,3 letras
  • Una disminución de 206,3 micrones en el grosor del campo central, lo que indica un secado de la retina

El estudio incluyó un 45% de participantes hispanos o latinos y un 48% de participantes negros o afroamericanos. Los resultados fueron coherentes con estudios previos de Fase III, y Vabysmo fue bien tolerado, sin nuevos eventos de seguridad identificados. Este estudio, pionero en su tipo, tiene como objetivo abordar las disparidades en salud y mejorar la representación en ensayos clínicos para poblaciones desproporcionadamente afectadas por el DME.

제넨텍ELEVATUM 연구에서 Vabysmo의 긍정적인 1년 결과를 발표했습니다. 이는 인종 및 민족적으로 소외된 그룹에서 당뇨병성 황반 부종(DME) 치료를 평가하였습니다. 연구 결과는 다음과 같습니다:

  • 참여자들은 1년 치료 후 평균 12.3글자를 추가로 읽을 수 있었습니다.
  • 히스패닉 및 라틴 참여자들은 평균 14.1글자를 획득했습니다.
  • 아프리카계 미국인 및 흑인 참여자들은 평균 11.3글자를 획득했습니다.
  • 중심 하위 분야 두께에서 206.3마이크론 감소가 발생하여 망막 건조를 나타냅니다.

이 연구에는 45%의 히스패닉 또는 라틴 참여자와 48%의 흑인 또는 아프리카계 미국인 참여자가 포함되었습니다. 결과는 이전의 3상 연구와 일치하였으며, Vabysmo는 안전성 문제 없이 잘 견뎌냈습니다. 이 전례 없는 연구는 건강 격차를 해소하고 DME의 영향을 받는 인구에 대한 임상 시험의 대표성을 개선하는 것을 목표로 하고 있습니다.

Genentech a annoncé des résultats positifs après un an d'étude du ELEVATUM, qui évaluait Vabysmo pour traiter l' dans des groupes raciaux et ethniques sous-représentés. L'étude a montré :

  • Les participants ont pu lire en moyenne 12,3 lettres supplémentaires après un an de traitement.
  • Les participants hispaniques et latinos ont gagné en moyenne 14,1 lettres.
  • Les participants afro-américains et noirs ont gagné en moyenne 11,3 lettres.
  • Une diminution de 206,3 microns d'épaisseur dans le champ central, indiquant un assèchement de la rétine.

L'étude a inclus 45 % de participants hispaniques ou latinos et 48 % de participants noirs ou afro-américains. Les résultats étaient cohérents avec des études précédentes de phase III, et Vabysmo a été bien toléré, sans nouveaux événements de sécurité identifiés. Cette étude, la première de son genre, vise à aborder les disparités en matière de santé et à améliorer la représentation dans les essais cliniques pour les populations touchées de manière disproportionnée par le DME.

Genentech hat positive Ergebnisse aus dem ELEVATUM-Studie bekannt gegeben, die Vabysmo zur Behandlung von diabetischem Makulaödem (DME) in unterrepräsentierten rassischen und ethnischen Gruppen bewertet. Die Studie ergab:

  • Die Teilnehmer konnten nach einem Jahr Behandlung im Durchschnitt 12,3 Buchstaben mehr lesen.
  • Hispanische und lateinamerikanische Teilnehmer gewannen im Durchschnitt 14,1 Buchstaben.
  • Afroamerikanische und schwarze Teilnehmer gewannen im Durchschnitt 11,3 Buchstaben.
  • Eine Abnahme von 206,3 Mikrometern in der Dicke des zentralen Subfeldes, was auf eine Austrocknung der Netzhaut hinweist.

In der Studie waren 45% hispanische oder lateinamerikanische und 48% schwarze oder afroamerikanische Teilnehmer vertreten. Die Ergebnisse stimmten mit früheren Phase-III-Studien überein, und Vabysmo wurde gut vertragen, ohne dass neue Sicherheitsereignisse identifiziert wurden. Diese neuartige Studie hat das Ziel, gesundheitliche Ungleichheiten zu bekämpfen und die Vertretung in klinischen Studien für die unverhältnismäßig von DME betroffenen Bevölkerungsgruppen zu verbessern.

Positive
  • Vabysmo showed clinically meaningful improvement in vision for underrepresented populations with DME
  • Participants gained an average of 12.3 letters (about 2.5 lines on an eye chart) after one year of treatment
  • Hispanic and Latino participants, who started with the most severe disease, gained an average of 14.1 letters
  • The study demonstrated robust retinal drying across racial and ethnic groups
  • Results were consistent with previous Phase III DME studies
  • Vabysmo is now approved in over 100 countries for DME and wet AMD
Negative
  • None.

– The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with DME treated with Vabysmo who identify as African American, Black, Hispanic and Latino –

– Efficacy and safety from this Phase IV study were consistent with data from the Vabysmo Phase III DME studies –

– These racial and ethnic groups are disproportionately affected by diabetes and at higher risk of developing DME, a leading cause of vision loss –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline one-year results from the open-label, single-arm Phase IV ELEVATUM study evaluating Vabysmo® (faricimab-svoa) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.

Initial data from 124 participants in the United States showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letters on average – equivalent to about two and a half lines on an eye chart. Results among major racial and ethnic groups represented in this study were similar. Hispanic and Latino participants started the study with the most severe disease and had an average vision gain of 14.1 letters from baseline at one year, equivalent to nearly three lines on an eye chart. African American and Black participants gained an average of 11.3 letters from baseline at one year. Vabysmo was well tolerated, with no new safety events identified.

These data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting in Chicago on October 18. The study is the first retina trial for historically underrepresented populations.

“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 investigator Jeremiah Brown, M.D., of Retina Consultants of Texas, who presented the data at AAO. “As a clinician who serves patients from these communities, 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 in the clinic daily.”

Results were consistent with the Phase III YOSEMITE and RHINE DME studies. A secondary endpoint showed robust retinal drying with Vabysmo across these racial and ethnic groups, who, on average, achieved a decrease of 206.3 microns in central subfield thickness (CST) from baseline. Reducing CST indicates retinal drying, which is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

“Though certain ethnic and racial groups are disproportionately affected by DME, they lag far behind in clinical trial representation,” said Gregory A. Rippon, M.D., M.S., vice president, U.S. Medical Affairs. “We conducted the ELEVATUM study to specifically address this issue and understand 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.”

Among the 124 patients, 45% self-identified as Hispanic or Latino, and 48% as Black or African American. The study was designed to facilitate enrollment and promote retention of underrepresented patients. For example, ELEVATUM was conducted at sites that treat a high proportion of these populations, in urban, rural, and community-based locations. In addition, eligibility criteria allowed participants with a hemoglobin A1c (HbA1c) level up to 12%. An HbA1c test measures a person’s average blood sugar levels over the past three months and is used to diagnose diabetes. Typically, the threshold for DME trials is an HbA1c level of 10%. However, HbA1c levels can be higher in Black, African American, Hispanic and Latino populations compared with Caucasians, meaning a lower HbA1c threshold can inadvertently lead to the exclusion of patients from various ethnic and racial groups.

“At Genentech we’re challenging the status quo and pioneering a new era of inclusive research that aims to directly address long standing health disparities,” said Quita Highsmith, vice president and chief diversity officer at Genentech. “The ELEVATUM study is a significant milestone that not only establishes a blueprint of best practices to enroll more diverse patients, but confirms our continued commitment to advancing inclusive research for all patients.”

To date, Vabysmo is approved in more than 100 countries for DME and wet, or neovascular, age-related macular degeneration (AMD), and in over 30 countries for macular edema following retinal vein occlusion (RVO). More than five million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.

Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Vabysmo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or https://www.Genentech-Access.com.

Visit https://www.Vabysmo.com for additional information.

About ELEVATUM

ELEVATUM (NCT05224102) is a Phase IV, multicenter, open-label, single-arm study designed to evaluate Vabysmo as a treatment for diabetic macular edema (DME) in patients that have been historically underrepresented in clinical trials, including people who self-identify as Black, African American, Hispanic or Latino. Trial participants have not been treated with an anti‑vascular endothelial growth factor before the study. They receive treatment every 4 weeks with Vabysmo up to week 20, followed by treatment every 8 weeks up to week 52.

The primary endpoint is change from baseline in best corrected visual acuity at week 56. Secondary endpoints include safety and change in central subfield thickness from baseline over time.

About Diabetic Macular Edema

Affecting approximately 750,000 people in the United States, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.

About the Vabysmo® (faricimab-svoa) Clinical Development Program

Genentech has a robust Phase III clinical development program for Vabysmo. The program includes AVONELLE-X, an extension study of TENAYA and LUCERNE, evaluating the long-term safety and tolerability of Vabysmo in wet age-related macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE, evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). The POYANG study is evaluating Vabysmo in adult treatment-naive patients with choroidal neovascularization secondary to pathologic myopia. Genentech has also initiated several Phase IV studies, including the ELEVATUM study of Vabysmo in underrepresented patient populations with DME and the SALWEEN study of Vabysmo in a subpopulation of people with wet AMD that is highly prevalent in Asia. Genentech has also initiated the VOYAGER study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.

About Vabysmo® (faricimab-svoa)

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.

Vabysmo U.S. Indications

Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

Important Safety Information

Contraindications

Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.

Warnings and Precautions

  • Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
  • Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection.
  • Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with Vabysmo reported such an event.
  • Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Healthcare providers should discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions

The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 8%). These are not all the possible side effects of Vabysmo.

Pregnancy, Lactation, Females and Males of Reproductive Potential

  • Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
  • It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.

Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit https://www.Vabysmo.com.

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit https://www.gene.com.

Media Contact:

Shirley Dang, (650) 467-6800

Advocacy Contact:

Danielle Haney, (240) 805-4810

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Source: Genentech

FAQ

What were the results of the ELEVATUM study for Vabysmo (RHHBY) in treating DME?

The ELEVATUM study showed that after one year of treatment with Vabysmo, participants could read an additional 12.3 letters on average, equivalent to about 2.5 lines on an eye chart. Hispanic and Latino participants gained an average of 14.1 letters, while African American and Black participants gained an average of 11.3 letters.

How did Vabysmo (RHHBY) perform in reducing retinal fluid in DME patients?

Vabysmo demonstrated robust retinal drying across racial and ethnic groups in the ELEVATUM study. On average, participants achieved a decrease of 206.3 microns in central subfield thickness from baseline, indicating significant reduction in retinal fluid.

What was unique about the ELEVATUM study for Vabysmo (RHHBY)?

The ELEVATUM study was the first retina trial specifically designed for historically underrepresented populations in DME treatment. It included 45% Hispanic or Latino and 48% Black or African American participants, addressing the lack of representation in clinical trials for these groups disproportionately affected by DME.

How does the ELEVATUM study of Vabysmo (RHHBY) impact future clinical trials?

The ELEVATUM study establishes a blueprint for enrolling more diverse patients in clinical trials. It demonstrates Genentech's commitment to inclusive research and may influence how future clinical trials are designed to better represent underserved populations affected by eye diseases like DME.

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