Article
Hematology
Swetha Kambhampati, Monica Saumoy, Yecheskel Schneider, Steve Serrao, Pejman Solaimani, Lihua Elizabeth Budde, Matthew G. Mei, Leslie L. Popplewell, Tanya Siddiqi, Jasmine Zain, Stephen J. Forman, Larry W. Kwak, Steven T. Rosen, V. Alexey Danilov, Alex F. Herrera, Nikhil R. Thiruvengadam
Summary: The ZUMA-7 study demonstrated that second-line axicabtagene ciloleucel improved event-free survival in patients with relapsed/refractory DLBCL. However, its cost-effectiveness is highly dependent on long-term outcomes, and the routine use of this therapy will significantly increase healthcare expenditures.
Review
Oncology
Najat Bouchkouj, Megan Zimmerman, Yvette L. Kasamon, Cong Wang, Tianjiao Dai, Zhenzhen Xu, Xiaofei Wang, Marc Theoret, Tejashri Purohit-Sheth, Bindu George
Summary: This article summarizes the clinical review and regulatory considerations on the approval of axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma. The study showed high objective response rate and long duration of response in patients who received the therapy. However, safety concerns were also identified, leading to the implementation of a risk evaluation and mitigation strategy.
Article
Pharmacology & Pharmacy
Karthik Nath, Kitsada Wudhikarn, Ana Alarcon Tomas, Miguel-Angel Perales
Summary: This review discusses the safety considerations of axicabtagene ciloleucel in patients with large B-cell lymphoma, including the commonly observed immune-mediated toxicities of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. Additionally, it reviews CAR T-cell therapy related cytopenias, infection, organ dysfunction, and the recently described hemophagocytic lymphohistiocytosis.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Medicine, General & Internal
Jason R. Westin, Olalekan O. Oluwole, Marie Jose Kersten, David B. Miklos, Miguel-Angel Perales, Armin Ghobadi, Aaron P. Rapoport, Anna Sureda, Caron A. Jacobson, Umar Farooq, Tom van Meerten, Matthew Ulrickson, Mahmoud Elsawy, Lori A. Leslie, Sridhar Chaganti, Michael Dickinson, Kathleen Dorritie, Patrick M. Reagan, Joseph McGuirk, Kevin W. Song, Peter A. Riedell, Monique C. Minnema, Yin Yang, Saran Vardhanabhuti, Simone Filosto, Paul Cheng, Shilpa A. Shahani, Marco Schupp, Christina To, Frederick L. Locke
Summary: In this study, patients with early relapsed or refractory large B-cell lymphoma who received axicabtagene ciloleucel (axi-cel) as second-line treatment had significantly longer overall survival than those who received standard care, according to a 47.2-month follow-up.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Oncology
Allison Grana, Natalia Gut, Kiersten Williams, Joseph Maakaron, Kyle Porter, Basem M. William, Sumithira Vasu, Sam Penza, Jonathan E. Brammer, Ayman Saad, Marcin Puto, Samantha M. Jaglowski, Julianna Roddy
Summary: This retrospective study evaluated the safety events of axicabtagene ciloleucel treatment in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma. Almost all patients experienced cytokine release syndrome and/or neurotoxicity, indicating the need for real-life experience and data to better manage these toxicities specific to CAR-T therapy.
CLINICAL LYMPHOMA MYELOMA & LEUKEMIA
(2021)
Article
Oncology
Jason R. Westin, Frederick L. Locke, Michael Dickinson, Armin Ghobadi, Mahmoud Elsawy, Tom van Meerten, David B. Miklos, Matthew L. Ulrickson, Miguel-Angel Perales, Umar Farooq, Luciano Wannesson, Lori Leslie, Marie Jose Kersten, Caron A. Jacobson, John M. Pagel, Gerald Wulf, Patrick Johnston, Aaron P. Rapoport, Linqiu Du, Saran Vardhanabhuti, Simone Filosto, Jina Shah, Julia T. Snider, Paul Cheng, Christina To, Olalekan O. Oluwole, Anna Sureda
Summary: This study reported the outcomes of a preplanned subgroup analysis of patients aged >= 65 years with relapsed/refractory large B-cell lymphoma in the ZUMA-7 trial. The results showed that axicabtagene ciloleucel as a second-line therapy can improve event-free survival and have a manageable safety profile and improved patient-reported outcomes.
CLINICAL CANCER RESEARCH
(2023)
Article
Biochemistry & Molecular Biology
Emmanuel Bachy, Steven Le Gouill, Roberta Di Blasi, Pierre Sesques, Guillaume Manson, Guillaume Cartron, David Beauvais, Louise Roulin, Francois Xavier Gros, Marie Therese Rubio, Pierre Bories, Jacques Olivier Bay, Cristina Castilla Llorente, Sylvain Choquet, Rene-Olivier Casasnovas, Mohamad Mohty, Stephanie Guidez, Magalie Joris, Michael Loschi, Sylvain Carras, Julie Abraham, Adrien Chauchet, Laurianne Drieu La Rochelle, Benedicte Deau-Fischer, Olivier Hermine, Thomas Gastinne, Jean Jacques Tudesq, Elodie Gat, Florence Broussais, Catherine Thieblemont, Roch Houot, Franck Morschhauser
Summary: This study compared the efficacy and toxicity of Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The results showed that axi-cel had better overall response rate, complete response rate, progression-free survival, and overall survival compared to tisa-cel. However, axi-cel also had higher frequency of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome compared to tisa-cel.
Article
Medicine, General & Internal
F. L. Locke, D. B. Miklos, C. A. Jacobson, M-A Perales, M-J Kersten, O. O. Oluwole, A. Ghobadi, A. P. Rapoport, J. McGuirk, J. M. Pagel, J. Munoz, U. Farooq, T. van Meerten, P. M. Reagan, A. Sureda, I. W. Flinn, P. Vandenberghe, K. W. Song, M. Dickinson, M. C. Minnema, P. A. Riedell, L. A. Leslie, S. Chaganti, Y. Yang, S. Filosto, J. Shah, M. Schupp, C. To, P. Cheng, L. Gordon, J. R. Westin
Summary: This international phase 3 trial showed that axicabtagene ciloleucel therapy significantly improved event-free survival and response in patients with early relapsed or refractory large B-cell lymphoma compared to standard care, despite the expected high-grade toxic effects.
NEW ENGLAND JOURNAL OF MEDICINE
(2022)
Article
Medicine, General & Internal
Jee H. Choe, Hisham Abdel-Azim, William Padula, Mohamed Abou-El-Enein
Summary: This study evaluated the cost-effectiveness of CAR-T cell therapies for relapsed or refractory DLBCL. The results showed that second-line axicabtagene ciloleucel and third-line or later tisagenlecleucel were cost-effective, but uncertainty remains.
Article
Oncology
Mariana Bastos-Oreiro, Ana de las Heras, Maria Presa, Miguel A. Casado, Carlos Pardo, Victoria Martin-Escudero, Anna Sureda
Summary: This study assessed the cost-effectiveness and cost-utility of axi-cel versus tisa-cel in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) from the perspective of the Spanish National Health System. The analysis showed that axi-cel is highly cost-effective when compared to tisa-cel in adult patients with relapsed/refractory DLBCL in Spain.
Article
Hematology
Jennifer M. Logue, Elisa Zucchetti, Christina A. Bachmeier, Gabriel S. Krivenko, Victoria Larson, Daniel Ninh, Giovanni Grillo, Biwei Cao, Jongphil Kim, Julio C. Chavez, Aliyah Baluch, Farhad Khimani, Aleksandr Lazaryan, Taiga Nishihori, Hien D. Liu, Javier Pinilla-Ibarz, Bijal D. Shah, Rawan Faramand, Anna E. Coghill, Marco L. Davila, Bhagirathbhai R. Dholaria, Michael D. Jain, Frederick L. Locke
Summary: A retrospective study of 85 patients receiving axi-cel for LBCL found that prolonged cytopenias and infections were common post-treatment, with most patients experiencing recovery of these conditions over time. Infections within the first 30 days were associated with various factors, but no late deaths were attributed to infection.
Article
Oncology
Na Li, Bin Zheng, Hongfu Cai, Ting Yang, Yunda Hong, Maobai Liu, Jianda Hu
Summary: This study evaluated the cost-effectiveness of AxiCel compared to salvage chemotherapy for the treatment of R/R DLBCL. The results showed that AxiCel is not likely to be a cost-effective option due to its high price and lower cost-effectiveness compared to salvage chemotherapy.
SUPPORTIVE CARE IN CANCER
(2022)
Article
Oncology
Caron A. Jacobson, Julio C. Chavez, Alison R. Sehgal, Basem M. William, Javier Munoz, Gilles Salles, Pashna N. Munshi, Carla Casulo, David G. Maloney, Sven de Vos, Ran Reshef, Lori A. Leslie, Ibrahim Yakoub-Agha, Olalekan O. Oluwole, Henry Chi Hang Fung, Joseph Rosenblatt, John M. Rossi, Lovely Goyal, Vicki Plaks, Yin Yang, Remus Vezan, Mauro P. Avanzi, Sattva S. Neelapu
Summary: This study assessed the use of axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma and found that it showed high rates of durable responses and had a manageable safety profile.
Article
Oncology
Jared A. Cohen, Armin Ghobadi
Summary: Axicabtagene ciloleucel is the first cellular therapy approved for relapsed or refractory follicular lymphoma, demonstrating high rates of durable responses and a manageable toxicity profile in heavily pre-treated patients.
EXPERT REVIEW OF ANTICANCER THERAPY
(2022)
Article
Hematology
Megan Melody, Sangeetha Gandhi, Zaid Abdel Rahman, Paula Lengerke-Diaz, Nicole Gannon, Allison Rosenthal, Tuan Truong, Mattia Novo, Eva Brandes, Gina Lange, Breana Estby, Patrick Johnston, Steve Ansell, N. Nora Bennani, Jonas Paludo, Jose Villasboas Bisneto, Ernesto Ayala, Han W. Tun, Hemant S. Murthy, Vivek Roy, James Foran, Januario Castro, Yi Lin, Mohamed A. Kharfan-Dabaja
Summary: This retrospective analysis of 81 patients treated with axi-cel showed that 22.8% had hypoalbuminemia. Results indicated that axi-cel therapy appeared to overcome the adverse prognostic impact of hypoalbuminemia on overall survival and progression-free survival in these patients. Further large multicenter clinical studies are needed to validate these findings.
EUROPEAN JOURNAL OF HAEMATOLOGY
(2021)
