Plain Language Summary
What is this summary about?
This is a summary of a clinical study called ZUMA-7. ZUMA-7 looked at how the anti-cancer therapy axicabtagene ciloleucel (axi-cel) compared with standard treatment for people with large B-cell lymphoma (LBCL). LBCL is a cancer that affects a type of white blood cell called B cells. Axi-cel is a type of chimeric antigen receptor (CAR) T-cell therapy. This treatment is made from a person’s own immune cells and uses a person’s natural immune defences to fight cancer.
How was the study conducted?
The ZUMA-7 study was made up of 359 people whose LBCL came back (relapsed) within a year or did not fully respond (refractory) to their first cancer treatment plan. People in the study were randomly put into 2 treatment groups. 180 people were to get axi-cel,and 179 were to get standard-of-care treatment, which was chemotherapy and autologous stem cell transplantation. Before the results of ZUMA-7, this standard treatment was the most effective treatment for people with LBCL whose first treatment did not work. The researchers in ZUMA-7 determined the benefit of axi-cel by looking at how well the treatment worked and what side effects (toxicity) people had in the axi-cel group compared with the standard-of-care group.
What were the results?
At 2 years since joining the study, people in the axi-cel group lived without their cancer getting worse or needing new cancer treatment for a median time of about 8 months, compared with 2 months for people in the chemotherapy-based standard-of-care group. Most people in the axi-cel group were still alive after 4 years, but half the people in the standard-of-care group had died within about 31 months of treatment. The most common side effects from axi-cel were caused by an overactive immune system and
What do the results mean?
People with relapsed or refractory LBCL live longer and have better control of their cancer when treated with axi-cel compared with chemotherapy-based standard of care as their second anti-cancer treatment.
This is an abstract of the Plain Language Summary of Publication article.
View the full Plain Language Summary PDF of this article to read the full-text
Acknowledgements
The authors thank the patients, families, friends, and caregivers who were involved in the ZUMA-7 study as well as the study investigators, coordinators, and health care staff at each study site. We also acknowledge Meghan Gutierrez, Victor Gonzalez, and Sarah Quinlan from the Lymphoma Research Foundation for their review of this manuscript.
Author contributions
All authors of this summary were authors of the original publications and helped prepare this summary.
Disclosure statement
Frederick L Locke, MD: scientific advisory role/consulting role with A2 Bio, Allogene, Amgen, bluebird bio, Bristol Myers Squibb/Celgene, Calibr, Caribou Biosciences,Cellular Biomedicine Group, Cowen, Daiichi Sankyo, EcoR1, Emerging Therapy Solutions, GammaDelta Therapeutics, Gerson Lehrman Group (GLG), Iovance, Kite,a Gilead Company, Janssen, Legend Biotech, Novartis, Sana, Takeda, Wugen, and Umoja; patents, royalties, other intellectual property in several patents held by the institution in my name (unlicensed) in the field of cellular immunotherapy; travel support from A2 Bio; and other relationships with Allogene (Institutional),Aptitude Health, ASH, bluebird bio (Institutional), BioPharm Communications, CARE Education, Bristol Myers Squibb (Institutional), CERo Therapeutics (Institutional),Clinical Care Options Oncology, Imedex, Kite (Institutional), Novartis (Institutional), National Cancer Institute, Leukemia and Lymphoma Society, and Society for Immunotherapy of Cancer. Jason R Westin, MD: consulting/advisory role for Bristol Myers Squibb, Genentech, and Kite, a Gilead Company; and research funding from ADC Therapeutics, AstraZeneca, Bristol Myers Squibb, Calithera, Genentech, Kite, Kymera, MorphoSys/Incyte, and Novartis. Christina To, MD: former employment with Kite, a Gilead Company; and stock or other ownership in Gilead Sciences. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing support was provided by Christine N. Morrison, PhD, of Nexus Global Group Science, funded by Kite.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Funding
The ZUMA-7 study was funded by Kite.