Martin Dreyling, Nathan H Fowler, Michael Dickinson, Joaquín Martínez-López, Arne Kolstad, Jason Butler, Monalisa Ghosh, Leslie Popplewell, Julio C Chavez, Emmanuel Bachy, Koji Kato, Hideo Harigae, Marie José Kersten, Charalambos Babis Andreadis, Peter A Riedell, P Joy Ho, Jose Antonio Perez-Simon, Andy I Chen, Loretta J Nastoupil, Bastian von Tresckow, Andrés Jm Ferreri, Takanori Teshima, Piers Em Patten, Joseph P McGuirk, Andreas L Petzer, Fritz Offner, Andreas Viardot, Pier Luigi Zinzani, Ram Malladi, Ines Paule, Aiesha Zia, Rakesh Awasthi, Xia Han, Davide Germano, Darragh Stephen O'Donovan, Roberto Javier Ramos, Harald J Maier, Aisha Masood, Catherine Thieblemont, Stephen J Schuster
Tisagenlecleucel is approved for adults with relapsed/refractory (r/r) follicular lymphoma (FL) in the ≥3rd-line setting. The primary analysis (median follow-up: 17 months) of the Phase II ELARA trial (ClinicalTrials.gov identifier: NCT03568461) reported high response rates and excellent safety profile in extensively pretreated patients with r/r FL. Here we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after a median follow-up of 29 months. As of March 29, 2022, 97 patients with r/r FL (grades 1-3A) after ≥2 lines of therapy or who relapsed after autologous stem cell transplant received tisagenlecleucel infusion (0...
January 9, 2024: Blood