Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
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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.
Now that Yescarta has another indication for use, it poses a major threat to Breyanzi. BMS submitted a supplemental Biologics License Application (sBLA) for Breyanzi to the FDA, which the agency accepted in February 2022.
Breyanzi is also a CAR T-cell therapy. The drug has prior indications for use in other types of large B-cell lymphomas, but the sBLA submitted most recently is also for the treatment of adults with relapsed or refractory large B-cell lymphoma after a first-line therapy fails.
The FDA granted Breyanzi Priority Review and has said it will respond by June 24.
Gilead and BMS have had clinical and legal battles over the CAR T-cell space for more than five years. In 2017, BMS filed a lawsuit against Gilead and Kite Pharma over Yescarta, saying the drug infringed on Breyanzi’s patent. In 2019, a jury found that Kite had indeed infringed on the patent, which was originally created by Juno, a spinout of the Fred Hutchinson Cancer Research Center, and licensed from Memorial Sloan Kettering Cancer Center.
The guilty verdict required Kite to pay Juno and MSKCC $778 million, but Judge Philip Gutierrez increased that amount in 2020 to $1.2 billion.
However, BMS disagreed with the ruling and sought a review of the case. In August 2021, the decision was reversed. Gilead and Kite were allowed to continue the development of Yescarta and related CAR T-cell therapies.
Once Yescarta was back in the competitive space, both companies knew that they had to act quickly to gain market traction. Now that Yescarta has beaten Breyanzi to FDA approval, BMS has a lot of catch-up work to do.
The cancer immunotherapy market was worth roughly $119.4 billion last year. By 2031, the market is expected to hit a jaw-dropping $310 billion. Factors such a rising demand for biosimilar drugs and targeted therapy instead of systemic chemotherapy will continue to drive immuno-oncological drug demand.
