Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason ORCID: 0000-0002-6422-4404, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie Jose, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Perez-Simon, Jose Antonio, Chen, Andy, I, Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andres Jose Maria, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Masood, Aisha, Anak, Oezlem, Schuster, Stephen J. and Thieblemont, Catherine (2022). Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat. Med., 28 (2). S. 325 - 343. BERLIN: NATURE PORTFOLIO. ISSN 1546-170X

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Abstract

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. In a prespecified interim analysis of a pivotal phase 2 trial, tisagenlecleucel, an autologous CD19-targeting CAR-T cell therapy, produced a high rate of complete responses with a manageable safety profile in adults with relapsed or refractory follicular lymphoma

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fowler, Nathan HaleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dickinson, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martinez-Lopez, JoaquinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolstad, ArneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Butler, JasonUNSPECIFIEDorcid.org/0000-0002-6422-4404UNSPECIFIED
Ghosh, MonalisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Popplewell, LeslieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chavez, Julio C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bachy, EmmanuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kato, KojiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harigae, HideoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kersten, Marie JoseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andreadis, CharalambosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Riedell, Peter A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ho, P. JoyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Perez-Simon, Jose AntonioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chen, Andy, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nastoupil, Loretta J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferreri, Andres Jose MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Teshima, TakanoriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patten, Piers E. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McGuirk, Joseph P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petzer, Andreas L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Offner, FritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viardot, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zinzani, Pier LuigiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malladi, RamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zia, AieshaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Awasthi, RakeshUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Masood, AishaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anak, OezlemUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schuster, Stephen J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thieblemont, CatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-607918
DOI: 10.1038/s41591-021-01622-0
Journal or Publication Title: Nat. Med.
Volume: 28
Number: 2
Page Range: S. 325 - 343
Date: 2022
Publisher: NATURE PORTFOLIO
Place of Publication: BERLIN
ISSN: 1546-170X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CELLULAR KINETICS; RITUXIMAB; IDELALISIB; INHIBITION; MANAGEMENTMultiple languages
Biochemistry & Molecular Biology; Cell Biology; Medicine, Research & ExperimentalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60791

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