New Data From Phase IIIb Study Reinforces Safety Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Hemophilia A

Nachrichtenquelle: Business Wire (engl.)
13.07.2020, 07:03  |  130   |   |   

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the second interim analysis of the Phase IIIb STASEY study, which reinforce the safety profile of Hemlibra (emicizumab-kxwh) characterized in the Phase III HAVEN clinical program. In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors, which was consistent with previous safety observations. Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor. These data were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2020 Virtual Congress, July 12-14, 2020.

“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, M.D., Ph.D., 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.”

The second interim analysis of the STASEY study included data from 193 patients with hemophilia A with factor VIII inhibitors, who received Hemlibra prophylaxis once-weekly. No cases of thrombotic microangiopathy or serious thrombotic events (TEs) related to Hemlibra were reported, and no new safety signals were observed. Thirty-three (17.1%) people reported a Hemlibra-related adverse event (AE). The most common AEs, occurring in 10% or more of people in the STASEY study, were common cold symptoms nasopharyngitis; (12.4%), headache (11.9%) and injection site reactions (ISRs) (11.4%). The ISRs reported were either mild or moderate in severity and no patients discontinued due to ISR. Annualized bleeding rates (ABR) were also consistent with previously reported observations from the Phase III HAVEN studies.

A separate analysis described management and outcomes of minor and unplanned major surgeries in patients receiving Hemlibra, although there was not a formal surgery endpoint in STASEY. Results suggest people with hemophilia A with factor VIII inhibitors who undergo certain minor surgeries while receiving Hemlibra may not need additional preventative (prophylactic) coagulation factor. The majority of minor surgeries (n=20/31) were performed without the use of prophylactic coagulation factor (64.5%) and, of these, 85% (n=17/20) did not result in treated post-operative bleeds. Of the unplanned major surgeries (n=9), eight were managed with prophylactic coagulation factor, four of which resulted in bleeds managed successfully with recombinant factor VIIa. These findings are consistent with results observed in a previous analysis of surgeries in the pivotal HAVEN studies.

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