KESTREL and KITE: 52-Week Results From Two Phase III Pivotal Trials of Brolucizumab for Diabetic Macular Edema.

Brown, David M; Emanuelli, Andrés; Bandello, Francesco; Barranco, Jose Juan Escobar; Figueira, João; Souied, Eric; Wolf, Sebastian; Gupta, Vishali; Ngah, Nor Fariza; Liew, Gerald; Tuli, Raman; Tadayoni, Ramin; Dhoot, Dilsher; Wang, Lixin; Bouillaud, Emmanuel; Wang, Ying; Kovacic, Lidija; Guerard, Nicolas; Garweg, Justus (2022). KESTREL and KITE: 52-Week Results From Two Phase III Pivotal Trials of Brolucizumab for Diabetic Macular Edema. American journal of ophthalmology, 238, pp. 157-172. Elsevier 10.1016/j.ajo.2022.01.004

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PURPOSE

To compare the efficacy and safety of brolucizumab with aflibercept in patients with diabetic macular edema (DME).

DESIGN

Double-masked, 100-week, multicenter, active-controlled, randomized trials.

METHODS

Subjects were randomized 1:1:1 to brolucizumab 3 mg/6 mg or aflibercept 2 mg in KESTREL (n = 566) or 1:1 to brolucizumab 6 mg or aflibercept 2 mg in KITE (n = 360). Brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by 12-week (q12w) dosing, with optional adjustment to every 8 weeks (q8w) if disease activity was identified at predefined assessment visits; aflibercept groups received 5 doses every 4 weeks (q4w) followed by fixed q8w dosing. The primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 52; secondary endpoints included the proportion of subjects maintained on q12w dosing, change in Diabetic Retinopathy Severity Scale score, and anatomical and safety outcomes.

RESULTS

At Week 52, brolucizumab 6 mg was noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters vs +10.5 letters; KITE: +10.6 letters vs +9.4 letters; P < .001), more subjects achieved central subfield thickness (CSFT) <280 µm, and fewer had persisting subretinal and/or intraretinal fluid vs aflibercept, with more than half of brolucizumab 6 mg subjects maintained on q12w dosing after loading. In KITE, brolucizumab 6 mg showed superior improvements in change of CSFT from baseline over Week 40 to Week 52 vs aflibercept (P = .001). The incidence of ocular serious adverse events was 3.7% (brolucizumab 3 mg), 1.1% (brolucizumab 6 mg), and 2.1% (aflibercept) in KESTREL; and 2.2% (brolucizumab 6 mg) and 1.7% (aflibercept) in KITE.

CONCLUSION

Brolucizumab 6 mg showed robust visual gains and anatomical improvements with an overall favorable benefit/risk profile in patients with DME.

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