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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2021-12-17

AUTHORS

Nathan Hale Fowler, Michael Dickinson, Martin Dreyling, Joaquin Martinez-Lopez, Arne Kolstad, Jason Butler, Monalisa Ghosh, Leslie Popplewell, Julio C. Chavez, Emmanuel Bachy, Koji Kato, Hideo Harigae, Marie José Kersten, Charalambos Andreadis, Peter A. Riedell, P. Joy Ho, José Antonio Pérez-Simón, Andy I. Chen, Loretta J. Nastoupil, Bastian von Tresckow, Andrés José María Ferreri, Takanori Teshima, Piers E. M. Patten, Joseph P. McGuirk, Andreas L. Petzer, Fritz Offner, Andreas Viardot, Pier Luigi Zinzani, Ram Malladi, Aiesha Zia, Rakesh Awasthi, Aisha Masood, Oezlem Anak, Stephen J. Schuster, Catherine Thieblemont

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. More... »

PAGES

325-332

Journal

TITLE

Nature Medicine

ISSUE

2

VOLUME

28

Author Affiliations

  • BostonGene, Waltham, MA, USA
  • Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia
  • Medizinische Klinik III, LMU Klinikum, Munich, Germany
  • Hospital 12 De Octubre, Complutense University, CNIO, Madrid, Spain
  • Oslo University Hospital, Oslo, Norway
  • Royal Brisbane Hospital, Herston, Queensland, Australia
  • Michigan Medicine University of Michigan, Ann Arbor, MI, USA
  • City of Hope Comprehensive Cancer Center, Duarte, CA, USA
  • Moffitt Cancer Center, Tampa, FL, USA
  • Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon, France
  • Kyushu University Hospital, Fukuoka, Japan
  • Tohoku University Hospital, Sendai, Japan
  • Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands
  • Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA
  • University of Chicago Medical Center, Chicago, IL, USA
  • Royal Prince Alfred Hospital and University of Sydney, Camperdown, New South Wales, Australia
  • Department of Hematology, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla, Universidad de Sevilla, Seville, Spain
  • Oregon Health and Science University, Portland, OR, USA
  • The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  • Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
  • Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
  • Hokkaido University Hospital, Sapporo, Japan
  • Department of Haematology, King’s College Hospital, London, UK
  • University of Kansas Hospital and Medical Center, Westwood, KS, USA
  • Internal Medicine I, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Linz, Austria
  • UZ Gent, Gent, Belgium
  • Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany
  • Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy
  • Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  • Novartis Pharma AG, Basel, Switzerland
  • Novartis Institutes for BioMedical Research, East Hanover, NJ, USA
  • Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
  • Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA
  • Hôpital Saint-Louis, Paris, France
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41591-021-01622-0

    DOI

    http://dx.doi.org/10.1038/s41591-021-01622-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1143964859

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/34921238


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