On April 1, 2022, FDA Approved Yescarta for Second-line Treatment of Large B-cell Lymphoma

On April 1, 2022, FDA Approved Yescarta for Second-line Treatment of Large B-cell Lymphoma

On April 1, 2022, Kite, a subsidiary of Gilead Sciences, announced that the U.S. Food and Drug Administration (FDA) has approved their CAR-T cell therapy product Yescarta® for the treatment of adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months after first-line chemoimmunotherapy.

The First FDA-Approved CAR-T Drug for Second-Line LBCL Treatment

This approval was based on the results of the ZUMA-7 clinical trial, where Yescarta® demonstrated a 6.3-month improvement in event-free survival (EFS) compared to the standard-of-care therapy. The two-year progression-free survival rate or survival without additional cancer treatment was 2.5 times higher with Yescarta® (40.5% vs 16.3%). This approval also makes Yescarta® the first FDA-approved CAR-T drug for second-line treatment of LBCL. Previously, in 2017, Yescarta® was approved for the treatment of adult LBCL patients after two or more lines of systemic therapy.

Regarding this development, Professor Ma Jun, Director of the Hematology and Oncology Institute of Harbin Medical University, Supervisor of the Chinese Society of Clinical Oncology (CSCO), and Vice Chairman of the Asian Society of Clinical Oncology, stated, “This is a significant advancement in CAR-T cell therapy. Yescarta® demonstrates substantially better efficacy than the standard-of-care treatments for relapsed or refractory LBCL patients over the past three decades, fundamentally changing our perspective on the treatment of hematological malignancies. It has the potential to become the new standard of care and transform the treatment paradigm for these patients.”

Yescarta® Shows Clear Treatment Advantages Over Standard-of-Care

In the United States, over 18,000 new cases of LBCL are diagnosed annually, and approximately 30-40% of LBCL patients require second-line treatment due to cancer relapse or refractory disease (failure to achieve remission after initial treatment). Data indicates that in 2018, there were 88,090 new cases of non-Hodgkin lymphoma (NHL) in China, with LBCL being the most common type.

The FDA’s approval was based on the results of the ZUMA-7 clinical trial, the first and largest global study comparing CAR-T therapy to the standard-of-care treatment used for decades. It was a randomized, open-label, global, multicenter Phase 3 study evaluating the safety and efficacy of Yescarta® versus standard second-line treatment in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. In this study, 359 patients from 77 global centers were randomly assigned in a 1:1 ratio to receive either a single infusion of Yescarta® or standard second-line treatment. Yescarta® treatment demonstrated statistically significant clinical advantages, with a four-fold improvement in EFS compared to the standard-of-care (8.3 months vs. 2.0 months), and a manageable safety profile. The two-year progression-free survival rate or survival without additional cancer treatment was 2.5 times higher with Yescarta® (40.5% vs. 16.3%). The study data was presented at the 2021 American Society of Hematology (ASH) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).

The First CAR-T Cell Therapy Recommended as Category 1 by NCCN

Due to Yescarta®’s outstanding efficacy, in March 2022, the National Comprehensive Cancer Network (NCCN) included it as a Category 1 recommendation for the treatment of “relapsed disease within 12 months or refractory disease” in diffuse LBCL. Yescarta® also became the first CAR-T cell therapy to receive a Category 1 recommendation from NCCN for any cancer type.

Industry analysts consider this approval a milestone in the development of CAR-T cell therapy, as it marks the first time the FDA has approved a CAR-T drug to replace the long-standing standard-of-care treatment, signifying a paradigm shift in treatment modalities. Patients now only need to receive a single infusion instead of a series of multi-step treatments, and compared to the standard-of-care, CAR-T therapy significantly improves patients’ quality of life.

Reference Material

[1] FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. Retrieved April 1, 2022, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma

[2] Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL). Retrieved April 1, 2022, from https://www.kitepharma.com/news/press-releases/2022/4/yescarta-receives-us-fda-approval-as-first-car-tcell-therapy-for-initial-treatment-of-relapsed-or-refractory-large-bcell-lymphoma-lbcl

[3] Globocan 2018

[4] NCCN Guidelines Version 2.2022 Diffuse Large B-Cell Lymphoma

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