Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of blood cancers, including certain leukemias, lymphomas, and multiple myeloma. However, Black and Hispanic patients were largely absent from the major clinical trials that led to the U.S. Food and Drug Administration approval of CAR T-cell therapies. In a study published in the journal Bone Marrow Transplantation, Thakkar et al reported that Black and Hispanic patients had outcomes and side effects following CAR T-cell therapy that were comparable to their White and Asian counterparts.
“Representation in cancer clinical trials is vital to ensuring that treatments are safe and effective for everyone,” said co-corresponding author of the paper Mendel Goldfinger, MD, a medical oncologist at Montefiore Health System, Assistant Professor of Medicine at Albert Einstein College of Medicine, and member of the Montefiore Einstein Cancer Center Cancer Therapeutics Program. “We couldn’t have been happier to learn that our patients who identify as Black and Hispanic have the same benefits from CAR T-cell therapy as White patients. We can only begin to say that a cancer treatment is transformational when these therapies benefit everyone who comes to us for care.”
People who identify as Black and Hispanic often have tumor biology, immune system biology, and side effects that are distinct from White people. However, very few minorities were enrolled in the major trials that led the FDA to approve CAR T-cell therapies.
Parity for Black and Hispanic Patients
The new study evaluated outcomes for 46 participants treated at Montefiore between 2015 and 2021. Seventeen of the participants were Hispanic, 9 were Black, 15 were White, and 5 were Asian.
Among Black and Hispanic patients, 58% achieved a complete response after treatment and 19% achieved a partial response. For White and Asian patients, 70% achieved a complete response and 20% had a partial response, indicating no statistical differences among racial and ethnic backgrounds. Results were similar with respect to major side effects experienced: approximately 95% of participants in each group had mild to moderate cytokine-release syndrome.
Diversifying Cancer Clinical Trials
Nationwide, only about 8% of clinical trial participants are from minority groups.
“Our findings demonstrate that we are able to effectively treat people from historically marginalized groups using CAR T-cell therapy; our hope is that more people from a diverse range of racial and ethnic backgrounds will be included in clinical trials,” said co-author Amit Verma, MBBS, Associate Director of Translational Science at Montefiore Einstein Cancer Center, Director of the Division of Hemato-Oncology at Montefiore and Einstein, and Professor of Medicine and Developmental/Molecular Biology at Einstein.
Disclosure: For full disclosures of the study authors, visit nature.com.
