BeiGene: A First Trial Authorized With a Median Time of 8.1 Weeks
Thanks to CATALIS’ FAST TRACK Evaluation Service, the BeiGene pharmaceutical company accelerated the authorization for its trial on chronic lymphoid leukemia (BGB-11417-301) in 3 Quebec hospitals with a median time of 8.1 weeks.
In fact, the CHU-Sherbrooke authorized the trial in 7.8 weeks and became the first site activated in Canada and the first to recruit a patient in Canada. As for the Centre hospitalier universitaire de Québec and the Charles-Le Moyne hospital, they authorized the trial in 8.0 and 8.6 weeks, respectively.
BGB-11417-301 is a Phase III open-label study comparing the combination of sonrotoclax and zanubrutinib with the combination of venetoclax and obinutuzumab in patients with chronic lymphocytic leukemia who have not received any prior treatment. Currently, monotherapy with a BTK (Bruton tyrosine kinase) inhibitor is effective in controlling chronic lymphoid leukemia disease, but it does not induce remission in most patients. Therefore, they must continue using the treatment, which causes increasingly frequent adverse effects in the long run.
BeiGene hopes this new trial will prove that combining venetoclax and ibrutnib would be more effective than taking a single drug to treat this disease and allow patients to achieve remission.
Citation BeiGene
The BGB-11417-301 trial will take place in 200 sites in 20 countries and aims to recruit a total of 640 people, including 18 in Quebec.
“The FAST TRACK research project evaluation method implemented by CATALIS, combined with the concerted efforts of our research teams, means that users of our healthcare facility have access to cutting-edge experimental treatment options.”. – Dr. André Carpentier, Scientific Director, Centre de recherche du CHUS
“The effective authorization of this trial will undoubtedly help us achieve our goal of making this promising treatment available to as many patients as possible.” – Dr. Dominique Toupin, Hemato-Oncologist, Professor of Medicine, Université de Sherbrooke, Researcher, Centre de recherche du CHUS
“The trial’s authorization in three Quebec hospitals is excellent news for people with chronic lymphocytic leukemia (CLL). Although there are effective treatments for CLL, remissions are not permanent, and many patients need to be treated again after a few years. We hope that the combination of different treatments will allow patients to achieve a deep, lasting, and perhaps even permanent, remission without harmful side effects. Clinical trials are essential to demonstrating whether this hope is justified. In addition, this study will allow people with CLL to access this promising potential treatment.” – Raymond Vles, Chair of the Board of LLC Canada and patient partner
Should you want more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
