On September 8, 2020 The CIBMTR (Center for International Blood and Marrow Transplant Research) reported that it has reached a study enrollment goal 2 years early, and 1,500 patients have now enrolled in the post-marketing safety study for Yescarta (axicabtagene ciloleucel) (Press release, Kite Pharma EU, SEP 8, 2020, View Source [SID1234564773]). The study is part of a collaboration with Kite, a Gilead Company.
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This collaboration between the CIBMTR and Kite tracks long-term outcomes of patients treated with Yescarta, a chimeric antigen receptor T-cell (CAR T) therapy. This study will generate real-world evidence to assess long-term safety and effectiveness. Enrollment is the first step in the study; next, researchers will follow the participants for at least 15 years. The U.S. Food and Drug Administration (FDA) has required this long-term study for Yescarta.
Yescarta is the first CAR T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
"This prospective study was created to meet a post-marketing requirement for this therapy, and the accrual completion is an important milestone," said Marcelo Pasquini, MD, MS, co-lead investigator and Senior Scientific Director of the CIBMTR; Cellular Therapy Registry Director; and Professor of Medicine, Division of Hematology / Oncology at the Medical College of Wisconsin. "Together, the CIBMTR and Kite are the first to have reached our target enrollment, and we are pleased to have done so ahead of our initial projections."
"Even though we’ve met our initial goal for this study, we continue to enroll people in the CIBMTR’s Cellular Immunotherapy Data Resource (CIDR). The CIBMTR will continue to reimburse medical centers for reporting cell therapy data," said Dr. Pasquini. The CIDR is part of a federal initiative to accelerate cancer research; medical centers and pharmaceutical companies can participate.
Interim and final study results will be shared with the FDA, and eventually, the public. For more information about the CIBMTR’s Cellular Immunotherapy Data Resource, visit cibmtr.org/About/WhatWeDo/CIDR.