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Disease Activity Assessments with Brolucizumab vs Aflibercept in Patients with nAMD in HAWK and HARRIER

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Abstract Number: 1158

AuthorBlock: Rishi P. Singh1, Robin Hamilton2, Jeffrey S. Heier3, Carl Regillo4, Mark C. Gillies5, Georges Weissgerber6, Jahangir Alam6, Pravin U. Dugel7
1Ophthalmology i-32, Cole Eye Institute, Cleveland, Ohio, United States; 2Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; 3Ophthalmic Consultants of Boston, Boston, Massachusetts, United States; 4Wills Eye Hospital, Philadelphia, Pennsylvania, United States; 5Macula Research Group, Sydney Eye Hospital, Sydney, New South Wales, Australia; 6Novartis Pharma AG, Basel, Switzerland; 7Retinal Consultants of Arizona,, Phoenix, Arizona, United States;

DisclosureBlock: Rishi P. Singh, Regeneron/Bayer Code C (Consultant), Novartis Code C (Consultant), Alcon Code C (Consultant), Genentech Code C (Consultant), Optos Code C (Consultant), Zeiss Code C (Consultant), Bausch + Lomb Code C (Consultant), Apellis Code F (Financial Support), Robin Hamilton, Allergan Code C (Consultant), Bayer Healthcare Code C (Consultant), Novartis Pharmaceuticals Code C (Consultant), Roche Code C (Consultant), Bayer Healthcare Code F (Financial Support), Novartis Pharmaceuticals Code F (Financial Support), Roche Code F (Financial Support), Allergan Code R (Recipient), Roche Code R (Recipient), Bayer Healthcare Code R (Recipient), Novartis PharmaceuticalsNovartis Pharmaceuticals Code R (Recipient), Jeffrey S. Heier, 4D Molecular Technologies Code F (Financial Support), Acucela Code F (Financial Support), Adverum Code F (Financial Support), Aerie Code F (Financial Support), Aerpio Code F (Financial Support), Allegro Code F (Financial Support), Apellis Code F (Financial Support), Asclepix Code F (Financial Support), Astellas Code F (Financial Support), Bayer Code F (Financial Support), BVI Code F (Financial Support), Coda Therapeutix Code F (Financial Support), Corcept Code F (Financial Support), Daiichi Sankyo Code F (Financial Support), Genentech/Roche Code F (Financial Support), Genzyme Code F (Financial Support), Heidelberg Code F (Financial Support), Hemera Code F (Financial Support), Janssen R&D Code F (Financial Support), Kanghong Code F (Financial Support), Kodiak Code F (Financial Support), Neurotech Code F (Financial Support), Notal Vision Code F (Financial Support), Novartis Code F (Financial Support), Ocular Therapeutix Code F (Financial Support), Carl Regillo, Allegro Code C (Consultant), Allergan Code C (Consultant), Genentech Code C (Consultant), Iconic Code C (Consultant), Kodiak,Merck Code C (Consultant), Notal Vision Code C (Consultant), Novartis Code C (Consultant), Santen Code C (Consultant), Shire Code C (Consultant), Teva Code C (Consultant), Chengdu Kanghong Biotechnology Code C (Consultant), Aerpio Code F (Financial Support), Allergan Code F (Financial Support), Astellis Code F (Financial Support), Genentech Code F (Financial Support), Iconic Code F (Financial Support), Novartis Code F (Financial Support), Opthea Code F (Financial Support), Ophthotech Code F (Financial Support), Regeneron Code F (Financial Support), Chengdu Kanghong Biotechnology Code F (Financial Support), Mark C. Gillies, Allergan Code C (Consultant), Bayer Code C (Consultant), Novartis Code C (Consultant), Roche Code C (Consultant), Allergan Code F (Financial Support), Bayer Code F (Financial Support), Novartis Code F (Financial Support), Roche Code F (Financial Support), Georges Weissgerber, Novartis Code E (Employment), Jahangir Alam, Novartis Code E (Employment), Pravin U. Dugel, Bausch + Lomb Pharma Code C (Consultant), ORA Code C (Consultant), Annidis Code C (Consultant), Omeros Code C (Consultant), Alcon Surgical (RACII) Code C (Consultant), Santen Inc. Code C (Consultant), Clearside Biomedical Code C (Consultant), Shire Human Genetics Code C (Consultant), Genentech Code C (Consultant), Allergan Code C (Consultant), Avalanche Code C (Consultant), Opthea Code C (Consultant), Alcon Surgical Code C (Consultant), Ophthotech Code C (Consultant), TrueVision Code C (Consultant), Graybug Vision Code C (Consultant), Alcon Pharmaceutical Code C (Consultant), Lux BioScience Code C (Consultant), Orbis International Code C (Consultant), CDR-Life Inc Code C (Consultant), NeoVista Code C (Consultant), Digisight Code C (Consultant), Novartis Code C (Consultant), Lutronic Code C (Consultant), Irenix Code C (Consultant)

To compare the presence of disease activity (DA) over 96 weeks in HAWK and HARRIER, two Phase III, prospective trials that assessed the efficacy and safety of brolucizumab (Bro) vs aflibercept (Afl) in treatment-naïve patients with nAMD.

Patients were randomized 1:1:1 to Bro 3mg (n=358), 6mg (n=360) or Afl 2mg (n=360) in HAWK, or 1:1 to Bro 6mg (n=370) or Afl 2mg (n=369) in HARRIER. After 3 monthly loading doses, Bro patients received 12-week (q12w) dosing unless DA was present (as identified by masked investigator) at any predefined disease activity assessment (DAA) visit and resulted in permanent 8-week (q8w) dosing; Afl was dosed at fixed q8w. DAA occurred at Weeks 16, 20, 32, 44, 56, 68, 80, 92 with additional DAA at Weeks 28, 40, 52, 64, 76, and 88 in HARRIER only. All patients continued with planned DAA until the study end based on DAA guidance described in the study protocol, where ultimately the masked investigator took the final treatment decision based on their clinical judgment. The first DAA at Week 16 allowed for head-to-head comparison between treatment arms for q8w dosing need.

At Week 16, DA presence and therefore q8w dosing need was statistically significantly lower with Bro vs Afl in both HAWK (Bro 3mg=28.1%; Bro 6mg=24.0% vs Afl=34.5%; p<0.03 for both) and HARRIER (Bro 6mg=22.7% vs Afl=32.2%; p=0.002). DA presence was higher with Afl vs Bro (HAWK/HARRIER: Afl=22.2% / 19.6% vs Bro 3mg=14.9% / 0%; Bro 6mg=13.6% / 15.7%) across all DAA from Week 16 through 96. Further, qualitative analysis of all DAA in HAWK/HARRIER showed that across all treatment arms (given the masked investigator assessment), in 71.4% / 67.7% of the cases anatomical signs of DA were present either alone (35.8% / 41.9%) or in combination with function (35.6% / 25.8%).

Together, the functional and anatomical DA evaluations in HAWK and HARRIER indicate that nAMD patients treated with Bro 6mg q12w/q8w have lower risk of DA occurrence than Afl and thereby better disease control.

Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.