Gilead Jumps Out Ahead of BMS in Second-Line B-Cell Lymphoma

Kite Pharma, a subsidiary of Gilead, announced that Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been approved by the U.S. Food and Drug Administration (FDA) in  second-line B-cell lymphoma. 

Yescarta is the first approved therapy to treat adult patients with relapsed or refractory large B-cell lymphoma. The drug’s approval is great news for Gilead as it comes ahead of the review date for competitor Bristol Myer’s Squibb’s Breyanzi in the same indication. 

The approval comes after positive results from Kite’s landmark ZUMA-7 clinical trial. In the Phase III trial, 359 patients with large B-cell lymphoma that was refractory to first-line chemoimmunotherapy, or with large B-cell lymphoma that had relapsed within 12 months of first-line chemoimmunotherapy were treated with Yescarta. The study compared Yescarta to the current standard of care

treatment, which is platinum-based chemoimmunotherapy. The primary endpoint of the trial was event-free survival (EFS), which included no disease progression. Secondary endpoints included objective response rate, overall survival, patient-reported outcomes and safety.

Positive results from the study showed that two years after treatment, the patients who took Yescarta were 2.5-times less likely to experience cancer progression or need any additional cancer treatment over patients treated with standard of care. Patients treated with Yescarta also had a median rate of event-free survival of 8.3 months, compared to only two months with platinum chemoimmunotherapy.

The safety profile of Yescarta was consistent with previous studies.

“Today’s approval marks an exciting new standard of care. The ZUMA-7 trial enabled us to look at the broader picture of what happens to patients after a decision is made to follow a particular treatment path,” said Dr. Frederick L. Locke, M.D., principal investigator and co-leader of the immuno-oncology program at the Moffitt Cancer Center. “Additionally, we have now amassed significant experience

with CAR T-cell therapy to better manage or prevent side-effects, making this treatment more accessible for older patients and those with medical conditions for whom the standard of care might be difficult.”

Yescarta has been a star product for Gilead and Kite for years. The ZUMA-7 clinical trial began in 2017. At the time, it was the largest Phase III randomized study of any CAR T-cell therapy in a second-line setting. Yescarta was the first CAR T-cell therapy to be approved by the FDA to treat adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Find out more in the press release.

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