CAR-T therapy trials show promise for earlier use in lymphoma
pharmafile | December 13, 2021 | News story | Sales and Marketing |
Earlier use of chimeric antigen receptor (CAR) T-cell therapy for relapse B-cell lymphoma has demonstrated efficacy at substantially improving outcomes for patients in two randomised clinical trials, in comparison with standard treatment.
Cell therapy is a relatively new treatment for certain blood cancers. It is hoped that the therapy might soon become the standard of care for people with a common form of lymphoma recurring after initial drug treatment fails.
After 2 years of follow-up in the ZUMA-7 trials of the therapy, patients treated with axicabtagene ciloleucel (axci-vel, Yescarta) had a median event-free survival (EFS) of 8.3 months. This compares to the 2 months EFS of standard care, consisting of chemotherapy and stem-cell transplantation for patients who responded to chemotherapy.
The 24-month EFS was 40.5% with the axi-cel and 16.3% with standard care.
“ZUMA-7 met its primary event-free survival endpoint, demonstrating statistically significant and clinically meaningful improvement in efficacy with axi-cel versus second-line standard of care in relapsed and refractory large B-cell lymphoma (LBCL),” shared Frederick L Locke, MD, of Moffitt Cancer Center in Tampa, Florida, at an American Society of Hematology (ASH) press briefing. “Nearly three times the number of patients in the axi-cel arm received definitive therapy versus the standard-of-care arm. Axi-cel had a manageable safety profile consistent with previous studies.”
“In my opinion, this is a breakthrough therapy, which has shown superiority over standard of care after decades, in terms of not just efficacy, but also an extremely favorable safety profile,” said Manali Kamdar, MD, of the University of Colorado Cancer Center in Aurora. “We are extremely excited about the potential of this study to change the existing standard of care in these high-risk patients.”
The findings could propel earlier use of CAR-T cell therapies. Three CAR-T cell therapies are approved in the US for later-line treatment of diffuse large B-cell lymphoma. The FDA is already reviewing an application from Gilead, the maker of the CAR-T therapy, Yescarta, for an expanded clearance.
Ana Ovey
