Longer-Term Data Show Yescarta Reduces Mortality vs Other Therapies for FL

Yescarta, the first and only approved chimeric antigen receptor T-cell therapy for these patients, was shown to achieve durable responses in a majority of patients and reduced the risk of death compared with other treatments.

Data released during the European Hematology Association (EHA) 2021 Virtual Congress offer a longer-term look at the efficacy of axicabtagene ciloleucel (Yescarta) in relapsed or refractory follicular lymphoma (FL) 3 months after the FDA approved the treatment in this indication.

The data showed that Yescarta, the first and only approved chimeric antigen receptor T-cell therapy for these patients, achieved durable responses in a majority of patients and reduced the risk of death compared with other current treatments.

After at least 1.5 years of follow-up, 94% of patients in the phase 2 ZUMA-5 trial—an ongoing, single-arm, multicenter trial of 146 patients with relapsed or refractory indolent non-Hodgkin lymphoma, such as FL—achieved a response following treatment. At the time of analysis, median progression-free survival (PFS) and overall survival (OS) had not been reached.

“Follicular lymphoma is one of the most common non-Hodgkin lymphomas, and patients can experience frequent relapses, which quickly leaves us short of treatment options,” said study author John Gribben, MD, DSc, FRCP, FRCPath, FMed Sci, professor of medical oncology, Cancer Research UK Barts Centre, London, United Kingdom, and EHA 2019-2021 president, in a statement. “We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.”

Data from ZUMA-5 were also compared against that of the external cohort of patients with relapsed or refractory FL in the international SCHOLAR-5 trial. The weighted analysis revealed that Yescarta yielded superior PFS and OS compared with other available treatments.

A propensity score analysis of data from nearly 2 years in more than 80 patients from ZUMA-5 was compared against a weighted sample of 85 patients from the SCHOLAR-5 external cohort. Compared with the 94% of patients in the ZUMA-5 trial who achieved a response, half of the patients in the SCHOLAR-5 cohort achieved a response.

“The continued durable benefit demonstrated by axicabtagene ciloleucel at nearly 2 years is exciting, and the substantial survival benefit over current therapies that we’re seeing in the SCHOLAR-5 analysis is encouraging,” said Caron A. Jacobson, MD, MMSc, medical director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute, and assistant professor of medicine, Harvard Medical School, in a statement. “These follow-up data reinforce axicabtagene ciloleucel as an important advance for a group of patients who have historically had few options.”

There was a 58% reduction in death associated with Yescarta treatment and a 70% reduction in the risk of disease progression, relapse, or death compared with current therapies.

In the full cohort of patients in the ZUMA-5 trial, 8% and 21% of patients experienced grade 3 or higher cytokine release syndrome and neurologic toxicities, respectively.