Genentech recently announced the results from a second interim analysis of the STASEY study, designed to examine Hemlibra® as it relates to safety, efficacy and health-related quality of life in people with hemophilia A with FVIII inhibitors. Hemlibra® is laboratory-engineered to perform a key function in the clotting cascade that is normally carried out by the same factor VIII (FVIII) protein that is deficient in individuals with hemophilia A. These and additional study data were presented at the International Society of Thrombosis and Hemostasis Virtual Congress, held July 12-14, 2020.
The analysis included data from 193 patients with hemophilia A with factor VIII inhibitors, who received Hemlibra® prophylaxis once weekly. No cases of thrombotic microangiopathy (damage to small blood vessels inside vital organs) or serious thrombotic events (TEs) related to treatment with the product were reported, and no new safety signals were observed. A total of thirty-three patients (17.1%) reported an adverse event (AE) related to Hemlibra®. The most common AEs – occurring in 10% or more of people in STASEY – were cold symptoms (nasopharyngitis; 12.4%), headache (11.9%) and injection site reactions (ISRs) (11.4%). Incidents of ISRs were reported as either mild or moderate in severity, and none necessitated that a patient discontinue treatment. Annualized bleeding rates were also consistent with previously reported observations from the phase III HAVEN studies.
According to the Genentech press release, new interim data also suggests that patients receiving Hemlibra® may be able to undergo certain minor surgeries without the use of additional prophylactic factor replacement therapy.
“These important safety data continue to add to the extensive clinical evidence reinforcing Hemlibra’s potential to redefine the standard of care for people with hemophilia A,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “The STASEY study reflects our continued focus on providing valuable insights that meet the needs of the hemophilia community and enhance our understanding of Hemlibra in clinical practice.”
Source: Genentech press release dated July 12, 20202
