Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

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...

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Vydané v:	Nature Medicine Ročník 28; číslo 2; s. 325 - 332
Hlavní autori:	Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, 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., Thieblemont, Catherine
Médium:	Journal Article Magazine Article
Jazyk:	English
Vydavateľské údaje:	New York Nature Publishing Group US 01.02.2022 Nature Publishing Group
Predmet:	631/67/1990/291/1621/1915 692/308/2779/109/1941 692/699/1541/1990/291/1621/1915 692/699/67/1059/2325 Adult Adults Antigens Antigens, CD19 Autografts B-cell lymphoma Biomedical and Life Sciences Biomedicine Cancer Research CD19 antigen Cell therapy Chimeric antigen receptors Confidence intervals Cytokines Elara Humans Immune response Immunotherapy, Adoptive - adverse effects Infectious Diseases Life Sciences Lymphocytes Lymphocytes B Lymphocytes T Lymphoma Lymphoma, Follicular - drug therapy Metabolic Diseases Molecular Medicine Neurosciences Neurotoxicity Patients Pharmacokinetics Pilot Projects Receptors, Antigen, T-Cell - therapeutic use Risk groups Safety Safety management Stem cell transplantation Stem cells Survival
ISSN:	1078-8956, 1546-170X, 1546-170X, 1744-7933
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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
AbstractList	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. 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 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.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. 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
Author	Popplewell, Leslie Dreyling, Martin Kersten, Marie José Riedell, Peter A. Malladi, Ram Viardot, Andreas Fowler, Nathan Hale Offner, Fritz Zia, Aiesha Pérez-Simón, José Antonio Butler, Jason Bachy, Emmanuel Petzer, Andreas L. Masood, Aisha Teshima, Takanori Zinzani, Pier Luigi Nastoupil, Loretta J. Martinez-Lopez, Joaquin Anak, Oezlem Kato, Koji Ferreri, Andrés José María Ghosh, Monalisa Patten, Piers E. M. Awasthi, Rakesh Ho, P. Joy von Tresckow, Bastian Harigae, Hideo Chen, Andy I. Thieblemont, Catherine Chavez, Julio C. Schuster, Stephen J. Kolstad, Arne Andreadis, Charalambos McGuirk, Joseph P. Dickinson, Michael
Author_xml	– sequence: 1 givenname: Nathan Hale orcidid: 0000-0002-9494-1877 surname: Fowler fullname: Fowler, Nathan Hale email: nfowler@mdanderson.org organization: The University of Texas MD Anderson Cancer Center, BostonGene – sequence: 2 givenname: Michael surname: Dickinson fullname: Dickinson, Michael organization: Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the Sir Peter MacCallum Department of Oncology, University of Melbourne – sequence: 3 givenname: Martin surname: Dreyling fullname: Dreyling, Martin organization: Medizinische Klinik III, LMU Klinikum – sequence: 4 givenname: Joaquin surname: Martinez-Lopez fullname: Martinez-Lopez, Joaquin organization: Hospital 12 De Octubre, Complutense University, CNIO – sequence: 5 givenname: Arne surname: Kolstad fullname: Kolstad, Arne organization: Oslo University Hospital – sequence: 6 givenname: Jason surname: Butler fullname: Butler, Jason organization: Royal Brisbane Hospital – sequence: 7 givenname: Monalisa surname: Ghosh fullname: Ghosh, Monalisa organization: Michigan Medicine University of Michigan – sequence: 8 givenname: Leslie surname: Popplewell fullname: Popplewell, Leslie organization: City of Hope Comprehensive Cancer Center – sequence: 9 givenname: Julio C. surname: Chavez fullname: Chavez, Julio C. organization: Moffitt Cancer Center – sequence: 10 givenname: Emmanuel surname: Bachy fullname: Bachy, Emmanuel organization: Hospices Civils de Lyon and Université Claude Bernard Lyon 1 – sequence: 11 givenname: Koji surname: Kato fullname: Kato, Koji organization: Kyushu University Hospital – sequence: 12 givenname: Hideo orcidid: 0000-0003-4849-7442 surname: Harigae fullname: Harigae, Hideo organization: Tohoku University Hospital – sequence: 13 givenname: Marie José surname: Kersten fullname: Kersten, Marie José organization: Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam – sequence: 14 givenname: Charalambos surname: Andreadis fullname: Andreadis, Charalambos organization: Helen Diller Family Comprehensive Cancer Center, University of California San Francisco – sequence: 15 givenname: Peter A. surname: Riedell fullname: Riedell, Peter A. organization: University of Chicago Medical Center – sequence: 16 givenname: P. Joy surname: Ho fullname: Ho, P. Joy organization: Royal Prince Alfred Hospital and University of Sydney – sequence: 17 givenname: José Antonio surname: Pérez-Simón fullname: Pérez-Simón, José Antonio organization: Department of Hematology, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla, Universidad de Sevilla – sequence: 18 givenname: Andy I. surname: Chen fullname: Chen, Andy I. organization: Oregon Health and Science University – sequence: 19 givenname: Loretta J. orcidid: 0000-0001-6071-8610 surname: Nastoupil fullname: Nastoupil, Loretta J. organization: The University of Texas MD Anderson Cancer Center – sequence: 20 givenname: Bastian orcidid: 0000-0003-1410-4487 surname: von Tresckow fullname: von Tresckow, Bastian organization: Department I of Internal Medicine, Medical Faculty and University Hospital Cologne, University of Cologne, Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen – sequence: 21 givenname: Andrés José María surname: Ferreri fullname: Ferreri, Andrés José María organization: Lymphoma Unit, IRCCS San Raffaele Scientific Institute – sequence: 22 givenname: Takanori orcidid: 0000-0002-0941-271X surname: Teshima fullname: Teshima, Takanori organization: Hokkaido University Hospital – sequence: 23 givenname: Piers E. M. surname: Patten fullname: Patten, Piers E. M. organization: Comprehensive Cancer Centre, King’s College London, Department of Haematology, King’s College Hospital – sequence: 24 givenname: Joseph P. surname: McGuirk fullname: McGuirk, Joseph P. organization: University of Kansas Hospital and Medical Center – sequence: 25 givenname: Andreas L. surname: Petzer fullname: Petzer, Andreas L. organization: Internal Medicine I, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen – sequence: 26 givenname: Fritz surname: Offner fullname: Offner, Fritz organization: UZ Gent – sequence: 27 givenname: Andreas surname: Viardot fullname: Viardot, Andreas organization: Department of Internal Medicine III, University Hospital of Ulm – sequence: 28 givenname: Pier Luigi surname: Zinzani fullname: Zinzani, Pier Luigi organization: IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia “Seràgnoli”, Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna – sequence: 29 givenname: Ram surname: Malladi fullname: Malladi, Ram organization: Cambridge University Hospitals NHS Foundation Trust – sequence: 30 givenname: Aiesha surname: Zia fullname: Zia, Aiesha organization: Novartis Pharma AG – sequence: 31 givenname: Rakesh surname: Awasthi fullname: Awasthi, Rakesh organization: Novartis Institutes for BioMedical Research – sequence: 32 givenname: Aisha surname: Masood fullname: Masood, Aisha organization: Novartis Pharmaceuticals Corporation – sequence: 33 givenname: Oezlem surname: Anak fullname: Anak, Oezlem organization: Novartis Pharma AG – sequence: 34 givenname: Stephen J. surname: Schuster fullname: Schuster, Stephen J. organization: Lymphoma Program, Abramson Cancer Center, University of Pennsylvania – sequence: 35 givenname: Catherine orcidid: 0000-0002-9941-2448 surname: Thieblemont fullname: Thieblemont, Catherine organization: Hôpital Saint-Louis
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34921238$$D View this record in MEDLINE/PubMed https://hal.science/hal-04927424$$DView record in HAL
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Snippet	Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with...
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SubjectTerms	631/67/1990/291/1621/1915 692/308/2779/109/1941 692/699/1541/1990/291/1621/1915 692/699/67/1059/2325 Adult Adults Antigens Antigens, CD19 Autografts B-cell lymphoma Biomedical and Life Sciences Biomedicine Cancer Research CD19 antigen Cell therapy Chimeric antigen receptors Confidence intervals Cytokines Elara Humans Immune response Immunotherapy, Adoptive - adverse effects Infectious Diseases Life Sciences Lymphocytes Lymphocytes B Lymphocytes T Lymphoma Lymphoma, Follicular - drug therapy Metabolic Diseases Molecular Medicine Neurosciences Neurotoxicity Patients Pharmacokinetics Pilot Projects Receptors, Antigen, T-Cell - therapeutic use Risk groups Safety Safety management Stem cell transplantation Stem cells Survival
Title	Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial
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