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

Yescarta, a CAR-T cell therapy for large B-cell lymphoma (LBCL) developed by Kite Pharma, received a US FDA nod for initial therapy in relapsed patients or patients with refractory disease. 

Yescarta (axicabtagene ciloleucel) is Kite’s blockbuster, an autologous CAR-T cell therapy derived from the patient’s T cells and engineered to be a CD19-directed immunotherapy, and provides a therapeutic intervention for patients who do not respond favorably to chemotherapy or relapse.

The current FDA approval is based on results from the ZUMA-7 trial, a global multi-centre trial. The ZUMA-7 trials reported that Yescarta showed significant improvements in event-free survival, prolonged times without disease progression and no requirements of additional treatment with favorable safety profiles. Considered the largest and longest clinical trial studying the effect of CAR-T cell therapy for B cell lymphoma, ZUMA-7 looked at the therapeutic effects of one-time infusion of Yescarta after a conditioning regimen compared with immunochemotherapy, which is the standard of care for relapsed or refractory B cell lymphoma. 

From Late-line to Initial Therapy

Kite’s Yescarta has had a long positive run with regulatory approvals. It was first approved by the FDA in 2017 as a possible third option of treatment, based on ZUMA-1 trials. 5-year survival results from ZUMA-1 are very encouraging with over 40% survival and a large majority of them needing no further treatment. In 2020, it was approved in Australia and available on medical insurance plans, based on positive data from the Zuma-1 clinical trials. The positive results of the randomized ZUMA-7 trials demonstrate a potential paradigm shift in the treatment of large B-cell lymphoma. Yescarta has been consistently pushed for earlier use, based on its ability to induce dramatic improvements in patients. 

In a press release, Frederick L. Locke, MD, ZUMA-7 lead principal investigator and co-leader of the Immuno-Oncology Program at Moffitt Cancer Center in Tampa, Florida, said, “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. What we found was that axi-cel resulted in three times as many patients receiving treatment with curative intent (CAR T-cell therapy), and an overall better outcome for patients than the previous standard of care. 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.”

Author

Sahana Shankar