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CHICAGO -- Patients treated with the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) in the second line for early relapsed or refractory large B-cell lymphoma had significantly longer overall survival (OS) than those treated with standard care, according to an analysis of the.

At a median follow-up of 47.2 months among 359 patients, median OS was not reached in the axi-cel group (95% CI 28.6 months to not estimable) versus 31.1 months (95% CI 17.1-not estimable) in the standard-care group (HR for death 0.73, 95% CI 0.54-0.98, P=0.03), reported Jason Westin, MD, of the University of Texas MD Anderson Cancer Center in Houston, at the American Society of Clinical Oncology (ASCO) annual meeting.

The findings were also published in the .

The estimated 4-year OS rate was 54.6% (95% CI 47.0-61.6) with axi-cel and 46.0% (95% CI 38.4-53.2) with standard care consisting of chemotherapy and stem-cell transplantation for patients who responded to chemotherapy.

Westin emphasized that the 27% reduction in the risk of death with axi-cel was achieved despite the fact that 57% of patients in the standard-0f-care arm received subsequent third-line cellular immunotherapy, including CAR T-cell therapy, off protocol.

"With a median follow-up of 47.2 months, these mature survival data are consistent with curative therapy," Westin said. "To our knowledge, ZUMA-7 is the first randomized trial in any cancer to show an overall survival benefit for a CAR T-cell therapy over existing standard of care. And this is the first trial in nearly 30 years to significantly improve overall survival in the second-line setting for patients with large B-cell lymphoma who receive curative-intent therapy."

"Taken together, ZUMA-7 confirms axi-cel is a second-line standard of care for patients with refractory or early relapsed B-cell lymphoma, based on superior overall survival," he added.

ASCO-invited discussant Asher Alban Akmal Chanan-Khan, MD, of the Mayo Clinic in Jacksonville, Florida, pointed out that "giving CAR-T earlier in the treatment paradigm is likely a better choice for our patients."

He agreed that ZUMA-7 "must alter the current standard of care, making CAR-T, or axi-cel, based on the data we have, preferred second-line treatment in relapsed/refractory large B-cell lymphoma."

Westin and colleagues also reported that the investigator-assessed median progression-free survival (PFS) was 14.7 months (95% CI 5.4-43.5) with axi-cel versus 3.7 months (95% CI 2.9-5.3) with standard care (HR 0.51, 95% CI 0.38-0.67). The estimated 4-year PFS rates were 41.8% (95% CI 34.1-49.2) and 24.4% (95% CI 17.2-32.2), respectively.

The median investigator-assessed event-free survival (EFS) was 10.8 months (95% CI 5.0-25.5) with axi-cel and 2.3 months (95% CI 1.7-3.1) with standard care, and the estimated 4-year EFS rates were 38.9% and 17.3%, respectively (HR 0.42, 95% CI 0.33-0.55).

An earlier analysis of the trial's primary outcome (EFS according to central review) showed that at a median follow-up of 24.9 months, median EFS was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, with 24-month EFS rates of 41% and 16%, respectively. In 2022, ZUMA-7 data convinced the in adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

As for safety, Westin reported that cytokine release syndrome, as expected, was more common in the axi-cel arm (events of any grade: 92%; grade ≥3: 6%) as were neurologic events (grade ≥3: 92% vs 1% with standard care).

Hypogammaglobulinemia was reported in 11.2% of the patients in the axi-cel group, and prolonged hypogammaglobulinemia (≥6 months after the axi-cel infusion) was reported in 5.9%. Grade ≥3 prolonged cytopenia (≥6 months after the initiation of definitive therapy) was reported in 4.7% of patients in the axi-cel group.

Infections of any grade were reported in 44.7% in the axi-cel group and 31.5% in the standard-care group, while grade ≥3 infections were reported in 16.5% and 11.9%, respectively.

ZUMA-7 was conducted at 77 sites worldwide. Eligible patients had histologically confirmed large B-cell lymphoma that was refractory to first-line treatment or that had relapsed from complete remission no more than 12 months after the completion of first-line chemoimmunotherapy, including an anti-CD20 monoclonal antibody and an anthracycline-containing regimen.

Patients had a median age of 59, with 30% 65 and older. Seventy-four percent of patients had primary refractory disease, 45% had a high second-line age-adjusted International Prognostic Index (2 or 3 risk factors), 54% had an elevated lactate dehydrogenase level, 79% had stage III or IV disease, and 19% had high-grade B-cell lymphoma.