European Commission Approves Kite’s CAR T-cell Therapy Yescarta for Relapsed or Refractory Follicular Lymphoma

The European Commission approved Gilead Sciences subsidiary Kite Therapeutics’ CAR-T cell therapy Yescarta for the treatment of adult patients with relapsed or refractory follicular lymphoma after three or more lines of systemic therapy.

Photo: Christi Shaw, CEO of Kite

“Patients with advanced relapsed or refractory follicular lymphoma have a high need for new treatment options,” said Christi Shaw, CEO of Kite. “This is the third approved indication for a Kite cell therapy in Europe, and we are pleased to enable more patients with different lymphomas greater access to this treatment innovation.”

Follicular lymphoma (FL) is rare form of non-Hodgkin lymphoma in which tumors grow slowly but can become more aggressive over time. FL is the second most common type of lymphoma globally and accounts for approximately 22 percent of all lymphomas diagnosed worldwide. In Europe, approximately 27,000 new cases are diagnosed each year.

“Follicular lymphoma is often misunderstood as easy to treat or non-life-threatening, even when it has reached a significantly advanced stage,” said Nicola Mendelsohn, founder and chair of the Follicular Lymphoma Foundation. “For patients with later-line relapsed or refractory disease, it is often very aggressive. Axicabtagene ciloleucel (Yescarta) represents an important advance for a patient population in Europe with limited treatment options.”

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy. The approval is supported by data from the pivotal, single-arm phase 2 ZUMA-5 international study in adult patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Among patients who had received three or more lines of prior therapy (n=75), the overall response rate (ORR) was 91 percent, and the complete response (CR) rate was 77 percent at the 24-month analysis. The median duration of response (DoR) was 38.6 months, and the proportion of responders still in response at Month 24 was 56 percent.

Among all evaluable patients within ZUMA-5 (n=119), safety observations were consistent with the known safety profile for Yescarta. Grade ≥3 cytokine release syndrome (CRS) occurred in 6 percent of patients and neurologic events occurred 16 percent of patients. Most CRS cases (99 percent) of any grade resolved by the time of data cut-off and 60 percent of neurologic events were resolved within three weeks. The most significant and frequently occurring adverse events were CRS (77 percent), infections (59 percent) and encephalopathy (47 percent).

Author: Rare Daily Staff