Roche has announced data from its phase IIIb STASEY study of Hemlibra (emicizumab) in Haemophilia A, reinforcing the safety profile of the drug seen in the pivotal HAVEN 1 clinical trial.
The Swiss pharma giant announced the data at the International Society on Thrombosis and Haemostasis 2019 Congress in Melbourne, Australia, among 21 abstracts from its haemophilia programme, including five oral presentations.
The data from the pooled HAVEN studies showed that a high proportion of patients experienced zero treated bleeds on Hemlibra, and that this was maintained over a median of 83 weeks. Over 87% of participants had no treated joint bleeds and over 92% of participants experienced no spontaneous bleeds in each interval from week 25.
The STASEY trial was a single-arm, multicentre, open-label, Phase IIIb clinical trial to evaluate the safety and tolerability of Hemlibra prophylaxis in people with haemophilia A with factor VIII inhibitors. The study included 88 patients who had completed 24 weeks on study or discontinued, receiving subcutaneous Hemlibra 3 mg/kg/week for four weeks, followed by 1.5 mg/kg/week for the remainder of the treatment period.
“Data presented at ISTH continues to reinforce Hemlibra’s potential to redefine the standard of care for people living with haemophilia A,” said Sandra Horning, Roche’s chief medical officer and head of global product development.
She continued, “We are particularly excited to present the first interim analysis of safety data from the STASEY study, which adds to the growing body of evidence supporting Hemlibra as an important treatment option for people with haemophilia A.”
Haemophilia A is an inherited, serious disorder in which a person’s blood does not clot properly, leading to uncontrolled and often spontaneous bleeding, which affects around 320,000 people worldwide.
Approximately 50-60% of those who have it have a severe form of the disorder.