TY - JOUR
T1 - Tisagenlecleucel in adult relapsed or refractory follicular lymphoma
T2 - the phase 2 ELARA trial
AU - Fowler, Nathan Hale
AU - Dickinson, Michael
AU - Dreyling, Martin
AU - Martinez-Lopez, Joaquin
AU - Kolstad, Arne
AU - Butler, Jason
AU - Ghosh, Monalisa
AU - Popplewell, Leslie
AU - Chavez, Julio C.
AU - Bachy, Emmanuel
AU - Kato, Koji
AU - Harigae, Hideo
AU - Kersten, Marie José
AU - Andreadis, Charalambos
AU - Riedell, Peter A.
AU - Ho, P. Joy
AU - Pérez-Simón, José Antonio
AU - Chen, Andy I.
AU - Nastoupil, Loretta J.
AU - von Tresckow, Bastian
AU - Ferreri, Andrés José María
AU - Teshima, Takanori
AU - Patten, Piers E.M.
AU - McGuirk, Joseph P.
AU - Petzer, Andreas L.
AU - Offner, Fritz
AU - Viardot, Andreas
AU - Zinzani, Pier Luigi
AU - Malladi, Ram
AU - Zia, Aiesha
AU - Awasthi, Rakesh
AU - Masood, Aisha
AU - Anak, Oezlem
AU - Schuster, Stephen J.
AU - Thieblemont, Catherine
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Nature America, Inc.
PY - 2022/2
Y1 - 2022/2
N2 - Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8–20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8–78.3) and ORR 86.2% (95% confidence interval, 77.5–92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients.
AB - Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8–20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8–78.3) and ORR 86.2% (95% confidence interval, 77.5–92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients.
UR - http://www.scopus.com/inward/record.url?scp=85121424087&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121424087&partnerID=8YFLogxK
U2 - 10.1038/s41591-021-01622-0
DO - 10.1038/s41591-021-01622-0
M3 - Article
C2 - 34921238
AN - SCOPUS:85121424087
SN - 1078-8956
VL - 28
SP - 325
EP - 332
JO - Nature medicine
JF - Nature medicine
IS - 2
ER -