Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (February 2024)
16 slides from Bayer's technical presentation, Feb 3, 2024
Slide 1: Aflibercept 8 mg for PCV Subgroup in the PULSAR Study
Aflibercept 8 mg for PCV Subgroup in the PULSAR Study Gemmy Cheung,1,2 on behalf of the PULSAR study investigators 1Singapore Eye Research Institute, Singapore National Eye Centre, Singapore 2Duke-NUS Medical School, National University of Singapore, Singapore Presented at the 21st Annual Angiogenes
Slide 2: Disclosures
Disclosures nAMD • GC: Consultant fees, speaker fees, and grant funding from Avirmax, Bayer, Boehringer Ingelheim, Janssen, Novartis, Roche, Topcon, and Zeiss • The PULSAR study (NCT04423718) was sponsored by Bayer AG (Leverkusen, Germany) and co- funded by Regeneron Pharmaceuticals, Inc. (Tarrytown
Slide 3: Current Evidence in PCV Management
Current Evidence in PCV Management nAMD • Anti-VEGF therapy forms the backbone of standard of care for patients with PCV, whereas PDT may be used as adjunctive therapy • Efficacy and safety of aflibercept 2 mg monotherapy, using 3 initial monthly doses, followed by injections every 2 months or a tre
Slide 4: PULSAR: A 3-Arm Randomized, Double-Masked, Phase 3 Study
PULSAR: A 3-Arm Randomized, Double-Masked, Phase 3 Study nAMD Multicenter, randomized, double-masked study in patients with treatment-naïve nAMD Randomized at baseline 1 (2q8) : 1 (8q12) : 1 (8q16) 2q8 8q12 8q16 Aflibercept 2 mg every 8 weeks Aflibercept 8 mg every 12 weeks Aflibercept 8 mg every 16
Slide 5: PULSAR: Dosing Schedule and Regimen Modification
PULSAR: Dosing Schedule and Regimen Modification nAMD Primary Endpoint YEAR 1 Day 1 Wk 4 Wk 8 Wk 12 Wk 16 Wk 20 Wk 24 Wk 28 Wk 32 Wk 36 Wk 40 Wk 44 Wk 48 2q8 X X X X o X o X o X o X 8q12 X X X oa Xa o o Xa o o Xa o 8q16 X X X oa oa Xa o o o Xa o o YEAR 2 Wk 52 Wk 56 Wk 60 Wk 64 Wk 68 Wk 72 Wk 76 Wk
Slide 6: PULSAR: ICGA-Confirmed PCV in 139 Patients
PULSAR: ICGA-Confirmed PCV in 139 Patients nAMD PCV Subgroup by Raceb • PULSAR is a global study conducted across 223 sites in 27 countries • ICGA was optional and conducted in 296 patients in 13 countriesa Asian 69.8% • PCV present, n=139; PCV absent, n=154 White (n=97) 29.5% Not reported • PCV cou
Slide 7: Change in BCVA Through Week 96: Similar with 8q12 and 8q16 versus 2q8
Change in BCVA Through Week 96: Similar with 8q12 and 8q16 versus 2q8 PCV Subgroup Week 96 Week 48 Week 96 2q8 (n=54) +93 | 49.6 8q12(n=44) | 49.5 | +8.4 8qi6(n=41) | 47.5 | +8.2 a o Change in BCVA (ETDRS letters) uo 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 Week ° Over
Slide 8: Absolute BCVA Through Week 96: Similar in PCV Subgroup and Overall Population
Absolute BCVA (ETDRS letters) Absolute BCVA (ETDRS letters) Absolute BCVA Through Week 96: Similar in PCV Subgroup and Overall Population PCV Subgroup Week 48 Week 96 Week 48 2q8 (n=54) 66.8 67.2 8q12 (n=44) 65.8 64.8 8q16 (n=41) 67.5 68.3 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88
Slide 9: CST Through Week 96: Similar with 8q12 and 8q16 versus 2q8
CST Through Week 96: Similar with 8q12 and 8q16 versus 2q8 PCV Subgroup Week 48 Week 96 298 (n=54) 216 | 207 8qi2(n=4a) | 219 | 219 8q16(n=41) | 230 | 232 Absolute CST (um) 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 9 Week Overall Population Week 48 Week 96 2q8 (n=335) 236 | 225
Slide 10: Retinal Fluid Through Week 96: Marked Increase in Patients Without Retinal Fluid
Retinal Fluid Through Week 96: Marked Increase in Proportion of Patients Without Retinal Fluid PCV Subgroup m2q8 m8q12 =8qi6 mAIl8mg 2 ° Q °o a o ~ 2s oc 2s e353 lo OG cf 28 tw os 265 2s a: Baseline LOCF (data post-ICE were censored). “Without retinal fluid” defined as absence of intraretinal and su
Slide 11: Mean Number of Injections Through Week 96
Mean Number of Injections Through Week 96: Similar in PCV Subgroup and Overall Population PCV Subgroup? , Overall Population” 2) oO 5 5 a] a) oF & = < ie) ie) mS oO 3 3 = = a =) Cc c Cc Cc Q 8 8 = = 8q12 8q16 =F AS: Data are shown for patients who completed Week 96: 2q8, n=49; 8q12, n=40; 8q16,n=36.
Slide 12: Dosing Interval Extension in Year 2: Most Patients with PCV Qualified
Dosing Interval Extension in Year 2?: ax Most Patients with PCV Qualified for Extension ate Last Assigned Dosing Interval (PCV Subgroup) mq8 mqi2 mqi6 mq20 mq24 & i) @ c o ro a xe) i= 2 = fe} a re) 2 a Randomized to Randomized to 8q12 at BL (n=40)> 8916 at BL (n=36)> *Dosing intervals were extended
Slide 13: Polypoidal Lesions Through Week 48
Polypoidal Lesions Through Week 48 ~50% of patients had no polypoidal lesions at Week 48? | Screening | Week 48° 278% of patients had no active 2% polypoidal lesions?" at Week 48 94% 97% ~ n Bf fe} ED 2 £3 $3 fo} £s 25 ogo =o On ao Proportion of patients (%) with active polypoidal lesions 298 All 8
Slide 14: Total Area of Polypoidal Lesions: Similar Change From Baseline Through Week 96
Total Area of Polypoidal Lesions: Similar Change From Baseline Through Week 96 PCV Subgroup m2q8 m8q12 = 8q16 EX} BL (mm?)= 308) im S — © = Oo D © a Hl ° ° € £ 9 2 ® & © D c @ xo oO Ditia.are for patients with PCV who completed Week 96.
Slide 15: 96-Week Ocular Safety Profile of Aflibercept 8 mg
96-Week Ocular Safety Profile of Aflibercept 8 mg: Similar to 2 mg in PCV and Overall Populations nAMD PCV subgroup Overall population TEAE, n (%) in study eye 2q8 8q12 8q16 All 8 mg 2q8 8q12 8q16 All 8 mg n=54 n=44 n=41 n=85 n=336 n=335 n=338 n=673 Any ocular TEAE 21 (38.9) 20 (45.5) 20 (48.8) 40 (
Slide 16: Conclusions: Aflibercept 8 mg Monotherapy in PCV
Conclusions: Aflibercept 8 mg Monotherapy in PCV nAMD • Visual acuity gains from baseline were largely maintained from Week 48 to Aflibercept 8 mg Week 96 in the aflibercept 8q12, 8q16, and 2q8 PCV subgroups, with gains of monotherapya +8.4, +8.2, and +9.6 letters, respectively, from baseline to Wee