2023-03-22| Trials & Approvals

Kite’s Yescarta Yields a Success in a Phase 3 Trial for Treating Large B-Cell Lymphoma

by Richard Chau
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Kite Pharma, a subsidiary of Gilead Sciences, announced its latest results of ZUMA-7, a Phase 3 trial evaluating the safety and efficacy of axicabtagene ciloleucel (Yescarta) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In comparison with the standard of care (SOC) therapy, the company’s CAR T-cell therapy product showed a statistically significant improvement in overall survival (OS) for the initial treatment of adult patients. 

Related article: Kite’s Yescarta – The First CAR-T Cell Therapy Approved for B cell Lymphoma

A Potential Breakthrough for Lymphoma Treatment Beyond the Long-standing Approach

DLBCL represents the most common form of non-Hodgkin lymphoma (NHL) in the United States and worldwide, accounting for about 22% of newly diagnosed cases of B-cell NHL in the United States. More than 18,000 people are diagnosed with DLBCL each year. The disease can be cured in about half of all patients, yet about 30-40% of patients will need second-line treatment, as their cancer will either relapse or become refractory to initial treatment. 

The SOC treatment of DLBCL, which has been used for nearly three decades, is a multi-step process involving platinum-based salvage chemoimmunotherapy (combination of chemotherapy and the monoclonal antibody rituximab) regimen, followed by high-dose therapy (HDT) and stem cell transplant (ASCT) in those who respond to salvage therapy. In the ZUMA-7 study, this SOC treatment was selected as the active comparator for the purpose of comparing the effect of Yescarta.

In this study, 359 patients were randomized (1:1) to receive a single infusion of Yescarta or SOC second-line treatment, with event-free survival (EFS) being the primary endpoint and objective response rate (ORR) and overall survival (OS) as the key secondary endpoints. Based on Kite’s latest results, when compared to the SOC treatment, patients treated with Yescarta were about 2.5 times more likely (40.5% vs. 16.3%) to survive without cancer progression or the need for additional treatment in a period of two years. Besides, the Yescarta group showed approximately 4 times longer median EFS (8.3 months vs. 2.0 months), as well as a significant advantage in terms of ORR (83% vs. 50%).

Kite Stays Ambitious in the Field of CAR T-Cell Therapy

ZUMA-7 is considered a landmark trial as the first and largest Phase 3 study of any CAR T-cell therapy, with the longest follow-up. Data from this pivotal trial led to the U.S. FDA approval for the initial treatment of relapsed or refractory LBCL in April 2022 and European Union approval in October 2022. 

Apart from the LBCL, in late January, Kite announced the closing of the global strategic collaboration agreement to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma. In this regard, it is clear that the Southern California-based pharma company has the ambition of expanding its presence in the field of CAR T-cell therapy.

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