CAR-T therapy, a form of immunotherapy that stimulates T cells to recognize and destroy cancer cells, has revolutionized the treatment of blood cancers, including certain leukemias, lymphomas and, most recently, multiple myeloma. Black and Hispanic people, however, were largely absent from the large clinical trials that led to the US Food and Drug Administration’s approval of CAR-T cell therapies.
In a study published today in blood marrow transplant (BMT), Researchers at the Montefiore Einstein Cancer Center (MECC), designated by the National Cancer Institute, report that after CAR-T treatment, Black and Hispanic patients had outcomes and side effects comparable to their White and Asian counterparts.
“Participation in cancer clinical trials is critical to ensuring treatments are safe and effective for everyone,” said Mendel Goldfinger, MD, co-author of the paper, medical oncologist at Montefiore Health System, assistant professor of medicine at Albert Einstein College of Medicine and Fellow of the MECC Cancer Therapeutics Program. “We could not have been happier to learn that our patients who identify as Black and Hispanic are experiencing the same benefits from CAR-T therapy as white patients. We can only begin to say that cancer treatment is transformative when those therapies benefit everyone who is affected and comes to us for care.”
People who identify as Black and Hispanic often have tumor biology, immune system biology, and side effects that differ from White people. However, very few minorities were enrolled in the large studies that prompted the FDA to approve CAR-T cell therapy.
Parity for Black and Hispanic patients
The new BMT The study evaluated the outcomes of 46 participants treated in Montefiore between 2015 and 2021. Seventeen of the participants were Hispanic, 9 African American, 15 White, and 5 Asian.
Among Black and Hispanic patients, 58% achieved a complete response after treatment and 19% achieved a partial response. In White and Asian patients, 70% achieved a complete response and 20% a partial response, indicating no statistical difference between race and ethnic background. The results were similar in terms of the serious side effects experienced: About 95% of the participants in each group had mild to moderate cytokine release syndrome, a common side effect of immunotherapy where people experience fever and other flu-like symptoms.
Diversifying clinical cancer trials
“Our results show that we are able to effectively treat people from historically marginalized groups with CAR-T; we hope more people from different racial and ethnic backgrounds will be included in clinical trials,” said co-author Amit Verma, MBBS, Associate Director of Translational Science at MECC, Director of the Department of Hemato-Oncology at Montefiore and Einstein and Professor of medicine and developmental and molecular biology at Einstein. Ira Braunschweig, MD, Associate Professor of Medicine at Einstein and Director of Stem Cell Transplantation and Cell Therapy and Clinical Program Director for Hematologic Malignancies at Montefiore, is also a co-corresponding author on the study.
At Montefiore, approximately 80% of clinical trial participants are minorities, compared to the national figure of just 8%.
As an academic medical center, it is not enough to make novel therapies like CAR-T available”, “We must be at the forefront of making sure these treatments are effective for the communities we serve – this research reflects that commitment contrary.”
Susan Green-Lorenzen, study co-author, RN Montefiore Health System, System Senior Vice President of Operations, Albert Einstein College of Medicine, Montefiore
The study is titled “Efficacy and Safety of CAR-T Cell Therapy in Minorities”. In addition to Dr. Goldfinger, Verma and Braunschweig and Ms. Green-Lorenzen, other Einstein and Montefiore authors are Astha Thakkar, MD, Michelly Abreu, NP, Kith Pradhan, Ph.D., R. Alejandro Sica, MD, Aditi Shastri, MD, Noah Kornblum, MD, Nishi Shah, MD, MPH, Ioannis Mantzaris, MD, MS, Kira Gritsman, MD, Ph.D., Eric Feldman, MD, and Richard Elkind, PA-C.