June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Brolucizumab for treatment of diabetic macular edema (DME): 100-week results from the KESTREL and KITE studies
Author Affiliations & Notes
  • Charles Clifton Wykoff
    Retina Consultants of Texas, Houston, Texas, United States
  • Justus G Garweg
    Berner Augenklinik am Lindenhofspital and Swiss Eye Institute, Bern, Switzerland
    Department of Ophthalmology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • Carl Regillo
    4. Retina Service, Wills Eye Hospital, Thomas Jefferson University,, Philadelphia, Pennsylvania, United States
  • eric souied
    Ophthalmology, Hopital Intercommunal de Creteil,, Créteil, France
  • Sebastian Wolf
    Department of Ophthalmology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • Dilsher Dhoot
    California Retina Consultants, Santa Barbara, California, United States
  • Hansjüergen T Agostini
    Department of Ophthalmology, Medical Faculty, University of Freiburg, Freiburg, Germany
  • Andrew Chang
    8. Sydney Retina Clinic, Sydney Eye Hospital, Sydney University, Sydney, New South Wales, Australia
  • Augustinus Laude
    National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore
  • Lidija Kovacic
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • Lixin Wang
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • Ying Wang
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • Emmanuel Bouillaud
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • David M Brown
    Retina Consultants of Texas, Houston, Texas, United States
  • Footnotes
    Commercial Relationships   Charles Wykoff Adverum; Allergan; Bayer; Genentech/Roche; Kodiak; Novartis, Opthea, Regeneron, Regenxbio, Code C (Consultant/Contractor), Adverum; Allergan; Bayer; Genentech/Roche; Kodiak; Novartis, Opthea, Regeneron, Regenxbio, Code F (Financial Support); Justus Garweg Bayer, Novartis, AbbVie, Roche; has participated in industry-sponsored studies from Novartis, Bayer, Chengdu Kanghong, AbbVie, Alcon, Roche, Code C (Consultant/Contractor); Carl Regillo Adverum, Allergan, Apellis, Astellis, Chengdu Kanghong Biotechnology, Genentech, Iveric, Kodiac, Novartis, Opthea, Regeneron, Regenxbio; Consultant: Adverum, Aldeyra, Allergan, Apellis, Chengdu Kanghong Biotechnology, Genentech, Iveric, Kodiak, Merck, NGM Biopharmaceuticals, Notal Vision, Novartis, Regenxbio, Takeda, Teva, Thea , Code F (Financial Support); eric souied Allergan, Bayer, Novartis, Roche, Thea , Code F (Financial Support); Sebastian Wolf Bayer, Boehringer-Ingelheim, Chengdu Kanghong Biotech, Zeiss, Roche, Code C (Consultant/Contractor), Zeiss and Heidelberg Engineering, Code F (Financial Support); Dilsher Dhoot Alimera Sciences, Allergan, Bayer Healthcare Pharmaceuticals, EyePoint Pharmaceuticals, GENENTECH, Novartis, Alcon Pharmaceuticals, Optos Inc., Regeneron, Santen Inc , Code C (Consultant/Contractor); Hansjüergen Agostini Novartis, Code F (Financial Support), Novartis, Code R (Recipient); Andrew Chang Novartis, Bayer, Allergan, Roche, Alcon, Apellis, Code C (Consultant/Contractor), Novartis and Bayer, Code R (Recipient); Augustinus Laude Roche, Code C (Consultant/Contractor), Allergan, Bayer, Novartis, Code R (Recipient); Lidija Kovacic Novartis , Code E (Employment); Lixin Wang Novartis, Code E (Employment); Ying Wang Novartis, Code E (Employment); Emmanuel Bouillaud Novartis, Code E (Employment); David Brown Novartis, Roche and Bayer, Code C (Consultant/Contractor)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 3849. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Charles Clifton Wykoff, Justus G Garweg, Carl Regillo, eric souied, Sebastian Wolf, Dilsher Dhoot, Hansjüergen T Agostini, Andrew Chang, Augustinus Laude, Lidija Kovacic, Lixin Wang, Ying Wang, Emmanuel Bouillaud, David M Brown; Brolucizumab for treatment of diabetic macular edema (DME): 100-week results from the KESTREL and KITE studies. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3849.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : To present the 100-week results from the KESTREL and KITE studies that evaluated efficacy and safety of brolucizumab (BRO) versus aflibercept (AFL) in patients with DME.

Methods : KESTREL (NCT03481634) and KITE (NCT03481660) were two 100-week (W), double-masked, active-controlled, Phase 3 studies. In KESTREL, patient randomization was 1:1:1 to BRO 3mg, BRO 6mg or AFL 2mg; in KITE, randomization was 1:1 to BRO 6mg or AFL 2mg. The BRO arms received 5 loading doses every 6 weeks (q6w) followed by q12w dosing, with an option to adjust to q8w at predefined disease activity assessment visits. At W72 in KITE, based on the disease stability assessment by the masked investigator, there was an option to extend the treatment interval for BRO patients by 4 weeks i.e. from q12w to q16w or q8w to q12w. The AFL arms received 5 monthly loading doses followed by fixed q8w dosing until end of study.

Results : In both studies, BRO 6mg was non-inferior to AFL for the change in BCVA at W52 (primary endpoint) and the VA gains were maintained to W100 (change in BCVA (letters) from baseline: BRO 6mg +8.8 vs AFL+10.6, difference −1.7 [95% CI, −3.8, 0.4] in KESTREL; BRO 6mg +10.9 vs AFL +8.4, difference +2.6 [95% CI, 0.2, 4.9] in KITE). The change in central subfield thickness (CSFT) from baseline over the period W88 through W100 in BRO 6mg and AFL arms were −171.9µm vs −168.5µm in KESTREL; −196.6µm vs −173.4µm in KITE. Fewer BRO 6mg patients had IRF and/or SRF vs AFL at W100 (KESTREL, 41.8% vs 54.0%; KITE, 40.8% vs 56.9%). Of the BRO 6mg patients who successfully completed the first q12w cycle immediately after the loading phase, 70.2% remained on q12w interval in KESTREL and 69.6% on q12w/q16w interval in KITE up to W100. In KESTREL, intraocular inflammation (IOI) rates were 5.3%, 4.2% and 1.1% in BRO 3mg, BRO 6mg and AFL, respectively; incidence of retinal vascular occlusion (RO) and retinal vasculitis (RV) were 1.6% and 1.6% in BRO 3mg, 1.6% and 0.5% in BRO 6mg and, 0.5% and 0% in AFL arms, respectively. No new RV reported in Year 2 in KESTREL. In KITE, IOI rates were 2.2% in BRO 6mg vs 1.7% AFL; incidence of RO was 0.6% in both BRO 6mg and AFL arms; there were no cases of RV through W100.

Conclusions : The 100-week results from KESTREL and KITE reaffirm the efficacy of brolucizumab for the treatment of DME seen in the Year 1 data. The overall safety profile of BRO 6mg remained unchanged through Year 2.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×