SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of Swiss drug major Roche Group (RHHBY), announced Monday positive results from two studies. The first, Phase III HAVEN 3 study evaluating HEMLIBRA (emicizumab-kxwh), met its primary endpoint. Further, the Phase III IMpower150 study met its co-primary endpoint of progression-free survival.
The company noted that HAVEN 3 is a randomized, multicenter, open-label, Phase III study evaluating the efficacy, safety and pharmacokinetics of HEMLIBRA prophylaxis versus no prophylaxis in people with hemophilia A without inhibitors to factor VIII.
HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients. HEMLIBRA is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly. HEMLIBRA was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Chugai, Roche and Genentech.
Genentech said the trial showed a statistically 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 study also met key secondary endpoints.
Data from the HAVEN 3 study will be presented at an upcoming medical meeting and submitted to health authorities around the world for approval consideration.
Further, IMpower150 is a multicenter, open-label, randomized, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease.
The study demonstrated that the combination of TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer or NSCLC.
Initial observations for the co-primary endpoint of overall survival are encouraging. These data are not fully mature and the next OS analysis is expected in the first half of 2018.
These data will be presented at the European Society for Medical Oncology (ESMO) Immuno Oncology Congress in Geneva, Switzerland in December 2017.
Copyright RTT News/dpa-AFX