Abstract
What is this summary about?
This is a summary of a phase 3 clinical trial called CARTITUDE-4. This trial compared the anti-cancer therapy ciltacabtagene autoleucel (or cilta-cel) with standard therapies in people who have multiple myeloma, a cancer that affects specific kinds of blood cells called plasma cells. The people in the study had been treated with 1 to 3 previous treatments for multiple myeloma, including a common anti-myeloma treatment called lenalidomide, but their multiple myeloma did not get better.
How was the study in this summary conducted?
About half of the 419 participants in this study received cilta-cel, while the other half received standard therapies, or therapies that are commonly used to treat multiple myeloma. Participants who received cilta-cel had a type of immune cell called T cells collected from their blood and genetically modified to recognize a specific protein found on myeloma cells. These modified T cells, which comprise cilta-cel, were then infused back into the bloodstream.
What were the results of the study?
After approximately 1 year in the study, more participants were alive without their cancer getting worse in the cilta-cel group (76%) than in the standard therapies group (49%). The most common side effects in both groups were infections and low blood cell counts. Cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system) was common but mostly mild. Neurotoxicities (including immune effector cell–associated neurotoxicity syndrome, which can cause symptoms such as headaches, changes in consciousness, and difficulty with memory, attention, speaking, or understanding others) were less common and were reported in 20.5% of participants treated with cilta-cel.
What were the main conclusions reported by the researchers?
In CARTITUDE-4, more participants treated with cilta-cel showed improvements and were alive with control of their disease 12 months after receiving cilta-cel compared with participants who received standard therapies.
Clinical Trial Registration: NCT04181827 (CARTITUDE-4) (ClinicalTrials.gov)
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Financial disclosure
NP is an employee of Legend Biotech USA Inc. and has stock in Legend Biotech USA Inc. JS is an employee of and has stock in Johnson & Johnson. NL is an employee of and has stock in Janssen Research & Development. The authors have no other relevant information 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.
Writing disclosure
Emma Hinkle, PhD, of MedThink SciCom and was funded by Janssen Research & Development and Legend Biotech USA Inc.
Acknowledgments
The authors would like to thank the patients and investigators who participated in the CARTITUDE-4 trial, as well as study staff members who enrolled patients and those who were involved in data collection and analysis.
Competing interests disclosure
JSM has consulted and served on advisory boards for AbbVie; Amgen; Bristol Myers Squibb; Celgene; F. Hoffmann-La Roche; GSK; HaemaLogiX; Janssen Global Services, LLC; Karyopharm Therapeutics; Merck; Novartis; Pfizer Canada; Regeneron Pharmaceuticals; Sanofi-Aventis; Secura Bio; and Takeda Oncology. BD has consulted for Bristol Myers Squibb, Genentech, Janssen Biotech, Karyopharm Therapeutics, Natera, Sanofi Aventis, and Pfizer. HE has consulted with Amgen; Bristol Myers Squibb; GSK; Janssen Global Services, LLC; Sanofi Pasteur; and Takeda Oncology. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.