Roche's Genentech unit and Chugai Pharmaceutical reported Monday that a Phase III study of Hemlibra (emicizumab-kxwh) in adults and adolescents with haemophilia A without inhibitors to factor VIII met its primary endpoint. Results from the HAVEN 3 trial showed a significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving Hemlibra prophylaxis every week compared to those receiving no prophylaxis.
The companies noted that the study also met key secondary goals, including a significant and clinically meaningful reduction in the number of treated bleeds over time with Hemlibra prophylaxis dosed every two weeks compared to no prophylaxis. "Hemlibra is the first product to show superior efficacy to factor VIII prophylaxis," remarked Sandra Horning, Roche's head of global product development.
Roche also reported Monday results from a Phase III study showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small-cell lung cancer. Commenting on the results, Jefferies analyst Jeffrey Holford said "Roche has delivered a best case scenario with both Tecentriq's IMpower150 and Hemlibra's HAVEN 3 studies meeting their primary endpoints." Shares in the drugmaker rose as much as 5.6 percent on the news.
The HAVEN 3 trial enrolled 152 patients with haemophilia A who were previously treated with factor VIII therapy either on-demand or for prophylaxis. Patients who were previously treated on-demand with factor VIII were randomised to receive Hemlibra dosed once weekly or every other week, or no prophylaxis. Meanwhile, those previously treated with factor VIII prophylaxis received the weekly dosing schedule of Hemlibra.
According to Roche and Chugai, results showed that once-weekly Hemlibra prophylaxis was "superior" to factor VIII prophylaxis, as demonstrated by a significant and clinically meaningful reduction in treated bleeds in an intra-patient comparison of patients receiving Hemlibra prophylaxis compared to their prior factor VIII prophylaxis. The companies added that no thrombotic microangiopathy or thrombotic events occurred in the trial. Roche and Chugai noted that data from the study will be presented at an upcoming medical meeting and also submitted to regulators for approval consideration.
"These results in people with haemophilia A without inhibitors represent the next step forward in our clinical trial programme, which includes the positive HAVEN 1 and interim HAVEN 2 data in people with inhibitors," Horning said. Last week, the FDA approved Hemlibra to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A who have developed factor VIII inhibitors, with Roche pricing the therapy at approximately $482 000 during the first year of treatment and about $448 000 the following year.
Hemlibra is a bispecific factor IXa- and factor X-directed antibody created by Chugai and is being co-developed by the Japanese company, Roche and Genentech.
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