Bayer AG news

• Data from pivotal PHOTON trial demonstrate long term efficacy of aflibercept 8 mg with extended intervals comparable to Eylea (aflibercept 2 mg) at fixed 8-weekly dosing over two years
• Patients assigned to a 16-week dosing regimen at baseline received a mean of 7.8 injections (6 fewer than Eylea)
• Safety profile of aflibercept 8 mg in diabetic macular edema (DME) remains comparable to Eylea with no new signals identified

• Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D)
• CKD affects up to 40% of people with T1D
• A quarter of people with CKD associated with T1D progress to end-stage kidney disease
• Only limited treatment options are available for people with CKD and T1D, wit

• The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries
• Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims to uncouple efficacy from increased bleeding risk

Bayer today

• Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO)
• Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME)
• QUASAR is expected to enroll around 800 patients in 27 countries
• Stud

• New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg
• In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal disease

Bayer and its collaborator Regeneron will present new

• Bayer presents first Phase 1 results from its most advanced clinical Immuno-Oncology program, aryl hydrocarbon receptor (AhR) inhibitor BAY2416964
• New preclinical data on Bayer’s DGK zeta inhibitor being featured in oral presentation in New Drugs on the Horizon session
• New preclinical data on mutEGFR
• HER2 program, currently in Phase 1, will be presented
• Bayer progresses novel research around prostate cancer treatment darolutamide

• Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET
• CT at baseline
• Fifth major clinical trial for androgen receptor inhibitor (ARi) darolutamide, covering prostate cancer from early to metastatic stage

Bayer further expands the global clinical development program for the oral andr

• Nubeqa now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer
• Additional indication based on data from the pivotal Phase III ARASENS trial

The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate c

• In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA)
• XARENO evaluated the impact of Xarelto in patients with NVAF and CKD, given that VKAs are associated with worsening of renal function compared to non-vitamin K anta

• Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PULSAR and PHOTON
• In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as well as rapid and resilient fluid control to the comparator