CHMP Gives Kite’s Lymphoma Immunotherapy a Positive Opinion

On September 16, Kite, a Gilead Sciences company, announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Yescarta (axicabtagene ciloleucel), a treatment for lymphoma. The Chimeric Antigen Receptor (CAR) T-cell therapy’s approval is based on the results of the Phase 3 ZUMA-7 study.

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What does Yescarta treat?

Lymphoma is a cancer of the body’s anti-germ network, known as the lymphatic system. This system contains the lymph nodes, spleen, thymus gland, and bone marrow. One of the types of lymphoma is Non-Hodgkin’s lymphoma, wherein cancer forms in white blood cells and spreads tumors throughout the body. 

Typically, Non-Hodgkin lymphoma is treated with chemotherapy or radiotherapy. In certain cases, if the cancer is small enough, a biopsy might be enough for treatment. One example of this is cyclophosphamide, a chemotherapy that slows cancer’s growth by suppressing the immune system.

Yescarta, on the other hand, is a CAR T-cell therapy. The immunotherapy treats cancer with a patient’s own white blood cells, known as T-cells, after genetic modification. The edit causes the cells’ production of a protein called chimeric antigen receptor (CAR). Upon reintroduction, CAR attaches to a receptor on the surface of cancer cells and kills them. 

The ZUMA-7 Wins Over the EMA

ZUMA-7 is an ongoing Phase 3 clinical trial evaluating the safety and efficacy of a single infusion of Yescarta versus the current standard of care for second-line therapy. The study tested 359 adult patients with large B-cell lymphoma, a subtype of Non-Hodgkin lymphoma. The primary endpoint of the trial was event-free survival.

Overall, Yescarta-treated patients saw an average of 8.3 months of event-free survival compared to the standard of care’s average of 2.0 months. This data won a positive opinion from the CHMP on the immunotherapy. 

On the CHMP’s opinion, Christi Shaw, CEO of Kite, said, “Today’s positive CHMP opinion brings us a step closer to utilizing cell therapy earlier in the treatment journey, potentially transforming the standard of care for the most common and aggressive form of non-Hodgkin lymphoma.”

Going forward, the European Commission will review the CHMP’s opinion. Their final decision on granting marketing authorization for the treatment is expected in the coming months.

Author

Max Heirich