Novartis has announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu (brolucizumab) 3mg and 6mg in diabetic macular oedema (DME).
Following the KITE trial*, KESTREL is the second pivotal Phase III study of Beovu in DME. The trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6mg to aflibercept 2mg at year one. The trial also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6mg to aflibercept 2mg over week 40 through week 521. (Beovu 6mg is the marketed dose for neovascular age-related macular degeneration.)
Beovu has the potential, if approved, to offer DME patients better disease management
More than half of patients in the Beovu 6mg arm were maintained on a three-month dosing interval through year one, following the loading phase.1 Patients treated with Beovu 6mg experienced significant improvement in change of central subfield thickness (CST) from baseline over the period of week 40 through week 521. As non-inferiority in change in BCVA of brolucizumab 3mg was not demonstrated in KESTREL, no confirmatory testing of superiority on anatomical outcomes was performed. Further analyses on anatomical outcomes from KESTREL are ongoing.
“These results demonstrate that Beovu has the potential, if approved, to offer DME patients better disease management,” said Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology. “Based on these data and the strong results we saw earlier this year from the KITE clinical study, we look forward to working with regulatory authorities to bring Beovu to DME patients.”
In KESTREL, Beovu demonstrated an overall well-tolerated safety profile.1
Novartis announced positive topline results from another pivotal phase III study, KITE, in September 2020. The results from KESTREL support the positive results seen in KITE, reinforcing Beovu as a potential new treatment option for DME patients.
*Kite Pharma, Inc. is neither a sponsor nor associated with Novartis’ KITE trial.
1. Novartis data on file. December 2020.