ABSTRACT NUMBER - 100

PHASE III STUDIES OF BROLUCIZUMAB VERSUS AFLIBERCEPT IN NAMD: 48-WEEK PRIMARY AND KEY SECONDARY OUTCOMES FROM HAWK/HARRIER


Alex P Hunyor1,2,3, Glenn Jaffe4, Adrian Koh5, Yuichiro Ogura6, Andreas Weichselberge7, Frank Holz8, Pravin Dugal9

Meeting:  2018 RANZCO


SESSION INFORMATION

Date:      -

Session Title: POSTER ABSTRACT- RETINA

Session Time:      -

Purpose: To compare the efficacy and safety of bro- lucizumab versus aflibercept.
Methods: Patients were randomized 1:1:1 to brolu- cizumab 3/6 mg or aflibercept 2 mg (HAWK) or 1:1 to brolucizumab 6 mg or aflibercept 2 mg (HARRIER). After the loading phase, brolucizumab patients received q12w dosing with an option to adjust to q8w based on masked and predetermined disease activity assessments. The primary endpoint was non-inferiority of brolucizumab to aflibercept in BCVA change from baseline at Week 48. Key sec- ondary endpoints included proportion of patients on q12 treatment interval at Week 48 and change in anatomical and safety parameters.
Results: For the brolucizumab 6 mg arm, 57% (HAWK) and 52% (HARRIER) of patients were maintained on a q12w interval up to Week 48. Mean BCVA change from baseline to Week 48 was non-inferior vs aflibercept in both studies (P < 0.0001, both studies). At Week 48 in HAWK, mean change in BCVA ( SE) for brolucizumab 3 mg, bro- lucizumab 6 mg and aflibercept 2 mg was 6.1 (0.69), 6.6 (0.71) and 6.8 (0.71) ETDRS letters, respectively. At Week 48 in HARRIER, mean change in BCVA ( SE) for brolucizumab 6 mg and aflibercept 2 mg was 6.9 (0.61) and 7.6 (0.61) letters, respectively. Reductions in CST were greater, and significantly fewer patients had IRF and/or SRF in the brolucizu- mab 6 mg group versus aflibercept. Safety was com- parable between treatment arms. Conclusions: Brolucizumab is non-inferior in BCVA change at week 48 versus aflibercept, with the majority of brolucizumab patients maintained on a q12w dosing regimen after loading until Week 48.