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Novartis Phase III BEOVU data show potential in more diabetic macular edema patients

The Phase III KESTREL and KITE studies enrolled a total of 926 patients in 36 countries

Novartis announced positive one-year results of the Phase III KESTREL and KITE studies, evaluating the efficacy and safety of BEOVU (brolucizumab-dbll) 6 mg in diabetic macular edema (DME). Both studies met their primary endpoints of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline for BEOVU 6 mg versus aflibercept 2 mg at year one1. In KESTREL, patients on BEOVU 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg1. In KITE, patients on BEOVU 6 mg gained a mean of 10.6 letters versus 9.4 letters for patients on aflibercept 2 mg1. These results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. 

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In pre-specified secondary endpoints, fewer eyes treated with BEOVU had intraretinal and/or subretinal fluid (IRF/SRF) at week 32 (first assessment of disease activity) and week 52 versus eyes treated with aflibercept1. More eyes treated with BEOVU 6 mg than eyes treated with aflibercept achieved central subfield thickness (CSFT) levels below 280 μm at weeks 32 and 521. Fluid is a key marker of disease activity in DME and CSFT is a key indicator of fluid in the retina.

“Treatment for diabetic macular edema is a high unmet medical need in the US and globally. Our goal as physicians is to work on preventing blindness for the significant proportion of diabetics affected by this condition,” said David M Brown MD FACS, Director of Clinical Research, Retina Consultants of Texas and principal investigator of the KESTREL clinical trial. “DME patients often struggle with adherence due to the need to manage multiple comorbidities related to diabetes. The KESTREL and KITE clinical trials – the first pivotal trials to examine a longer dosing interval in the loading phase – confirm BEOVU’s potential to be an important therapy for these patients.”

To study its potential in reducing treatment burden, BEOVU was given at six-week dosing intervals during the loading phase versus aflibercept, which was given at the standard four-week dosing intervals, in line with its label. Following the loading phase, over half of the patients in the BEOVU 6 mg arm (55.1 per cent in KESTREL and 50.3 per cent in KITE) remained on a three-month dosing interval through year one, based on a treatment approach determined by disease activity assessment1. If disease activity was detected, BEOVU 6 mg patients were switched to two-month intervals through the end of the trial1. All aflibercept patients were on a two-month interval after the loading phase.

“We are pleased to share these data, which underscore BEOVU’s potential to address an unmet need in the DME landscape,” said Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals. “With these data demonstrating vision gains, fluid resolution and the potential for less frequent injections for eligible patients, we are one step closer to providing DME patients with a potential new treatment option.”

The Phase III KESTREL and KITE studies enrolled a total of 926 patients in 36 countries. BEOVU 6 mg is the commercialized dose in wet age-related macular degeneration (AMD)3. The brolucizumab 3 mg arm, which was only included in KESTREL, did not meet the primary endpoint1.

BEOVU was overall well-tolerated in KESTREL and KITE1. The most common ocular and non-ocular adverse events (≥5%) in KESTREL and KITE were conjunctival haemorrhage, nasopharyngitis and hypertension4. IOI rates in KESTREL were 4.7 per cent for brolucizumab 3 mg (including 1.6% retinal vasculitis), 3.7 per cent for BEOVU 6 mg (including 0.5 per cent retinal vasculitis), and 0.5 per cent for aflibercept 2 mg1. IOI rates in KITE were equivalent (1.7 per cent) between the BEOVU 6 mg and aflibercept 2 mg arms with no retinal vasculitis reported1. Retinal vascular occlusion was reported in KESTREL for brolucizumab 3 mg (1.1 per cent) and 6 mg (0.5 per cent), and in KITE for brolucizumab and aflibercept (0.6 per cent each). The majority of these events were manageable and resolved with or without treatment.

Novartis is committed to bringing BEOVU 6 mg to market for DME patients, subject to regulatory approvals, and will be submitting these one-year data from the KESTREL and KITE trials to global health authorities in H1 2021. Novartis anticipates two-year results from KESTREL and KITE later in 2021.

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