Gilead Releases 5-Year Follow-Up Data on Yescarta for Large B Cell Lymphoma

CAR T cell therapy shows long-term, sustainable survival in patients with refractory LBCL, according to the company’s Kite subsidiary.

Gilead subsidiary Kite announced positive 5-year follow-up data from the ZUMA-1 trial of axicabtagene ciloleucel (Yescarta) for the treatment of refractory large B-cell lymphoma (LBCL).

Among all patients treated with Yescarta, the 5-year overall survival (OS) rate was 42.6% (95% CI, 32.8 – 51.9). Among patients who had a complete response (CR), the rate of OS at 5 years was 64.4% (95% CI: 50.8 – 75.1), and the median survival time was not yet reached. Among the treated patients alive at 5 years, 92% have not received any additional treatment since their single infusion of Yescarta, suggesting a cure for these patients.

The data was presented on December 11, 2021 at the 63rd Annual Meeting and Exhibition of the American Society of Hematology (ASH) (Abstract # 1764).

“At 5 years, these data demonstrate an impressive and lasting survival benefit with axicabtagene ciloleucel in patients with refractory LBCL”, Caron Jacobson, MD, MMSc, ​​medical director of the immune effector cell therapy program at Dana- Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, said in a statement.

“Almost half of the patients in the ZUMA-1 trial are still alive at 5 years, a group that previously had an average life expectancy of just 6 months. These results are a truly transformative change in the standard of care for this disease, ”said Jacobson.

Since the 4-year analysis, there was 1 death in the study related to a malignant tumor secondary to previous chemotherapy and / or myelodysplastic syndrome related to chemotherapy while the individual was in complete remission by LBCL.

The presenters also reported that an exploratory analysis of ZUMA-1 data showed a high degree of correlation between long-term OS and event-free survival status (EFS), which could potentially support the use of l ‘EFS at 1 and 2 years as substitution criteria. for long-term OS in relapsed and refractory LBCL. No new safety signals were reported, including no drug-related secondary malignancies.

“Five-year survival in any cancer patient is an important milestone and the point at which we dare to consider the word ‘cure’,” said Frank Neumann, MD, PhD, global head of clinical development at Kite, in the release. . “We set out to develop a curative treatment, and Yescarta has delivered on that promise by transforming the outlook for LBCL for some of the sickest patients who have exhausted other treatment options. “

The most common side effects in patients with LCBL included cardiac arrhythmias, chills, constipation, cough, cytokine release syndrome (CRS), decreased appetite, diarrhea, dizziness, encephalopathy, fatigue, febrile neutropenia, fever, headache, hypotension, hypoxia, infections with unspecified pathogen, nausea, tachycardia, tremors and vomiting. Axicabtagene ciloleucel is approved with a risk assessment and mitigation strategy due to the risks of CRS and neurological toxicities.

CRS, including fatal or life-threatening reactions, has occurred in 88% of people with non-Hodgkin lymphoma (NHL), including grade ≥ 3 in 10%. CRS occurred in 94% of people with LBCL, including grade ≥ 3 in 13%.

Neurological toxicities, including fatal or life-threatening reactions, occurred in 81% (206/254) of all NHL patients receiving Yescarta, including grade ≥ 3 in 26%. Neurological toxicities occurred in 87% (94/108) of patients with LBCL, including grade ≥ 3 in 31%.

Axicabtagene ciloleucel was the first CAR T cell therapy to be approved by the FDA for the treatment of adult individuals with relapsed or refractory LBCL after 2 or more lines of systemic therapy.

Reference

Yescarta is the first CAR T cell therapy to report five-year survival data from a pivotal study showing sustainable long-term survival in patients with refractory large B-cell lymphoma. Gilead. Press release. December 11, 2021. Accessed December 13, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/12/yescarta-is-first-car-t-cell – therapy-to-report-five-year-survival-data-from-the-pivotal-study-showing-sustainable-long-term-survival-in-patients-with- refraction


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