Kite’s Yescarta Receives EU Approval for Relapsed/Refractory Follicular Lymphoma with 91% Overall Response Rate

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News on June 29, 2022 /BioValleyBIOON/ -- Gilead Sciences' cell therapy company, Kite Pharma, recently announced that the European Commission (EC) has approvedCD19 CAR-TCell Therapy Yescarta (axicabtagene ciloleucel)A New Indication:For the treatment of relapsed or refractory (R/R) follicular lymphoma after three or more lines of systemic therapyLymphoma(FL) Adult patients.Yescarta retains orphan drug designation (ODD) for this indication.

In the United States, Yescarta received accelerated approval in March 2021 as the first CAR-T cell therapy for the treatment of FL. Its specific indication is: for the treatment of adult patients with R/R FL who have received two or more lines of systemic therapy. Previously, in the United StatesFDAYescarta has been granted Breakthrough Therapy Designation for the treatment of FL.

This FL indication marks the second indication for Yescarta approved in the EU, and also represents the third cell therapy indication developed by Kite to be approved in the EU.Yescarta's first indication was approved in August 2018: for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.In addition, in December 2020, another CD19 CAR-T cell therapy developed by Kite Pharma was approved by the European Union, becoming the first CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL). The specific indication is: for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL).

FL is an indolent non-Hodgkin lymphoma (iNHL), in which malignant tumors grow slowly but become more aggressive over time. FL is the most common type of indolent lymphoma and the second most common type of lymphoma globally. FL accounts for approximately 22% of lymphoma cases diagnosed worldwide. In Europe, about 27,000 new cases are diagnosed annually.

The approval of FL indication is based on the results of the pivotal ZUMA-5 (NCT03105336) clinical trial. This is an ongoing, single-arm, open-label, international, multicenter Phase 2 study evaluating 122 adult patients (≥18 years) with R/R FL who had previously received at least two lines of systemic therapy, including a combination of an anti-CD20 monoclonal antibody and an alkylating agent. The study assessed the efficacy and safety of a single infusion of Yescarta. The primary endpoint was the overall response rate (ORR). Secondary endpoints included the complete response rate (CR), ORR and CR in patients receiving third-line or later therapy, duration of response (DoR), overall survival (OS), progression-free survival (PFS), and incidence of adverse events.

Data show,In patients who had previously received third-line or higher systemic treatment (n=75), the overall response rate (ORR) was 91%, with a complete response (CR) rate of 77%. The median duration of response (DoR) was 38.6 months, and the proportion of patients still experiencing response at 24 months was 56%.In all evaluable patients (n=119) in the ZUMA-5 study, safety observations were consistent with the known safety profile of Yescarta. The incidence of grade ≥3 cytokine release syndrome (CRS) was 6%, and the incidence of neurological events was 16%. Most CRS cases (99%) were resolved by the data cutoff date, and 60% of neurological events were resolved within three weeks. The most significant and common adverse events were CRS (77%),Infection(59%) and encephalopathy (47%).

Ibrahim Yakoub Agha, Director of the Hematopoietic Cell Transplantation and Cell Therapy Department at Lille University Hospital in France, commented: "Relapsed/refractory FL is a difficult-to-treat disease with a particularly poor prognosis, as only 20% of patients remain alive five years after the second relapse.In the ZUMA-5 study, 91% of patients who had previously received three or more lines of therapy showed a response to Yescarta treatment, with more than half still experiencing relief after two years. This durable response is crucial for patients in need of treatment options that can provide long-term benefits.” (Bioon.com)

Source of Original Text:Kite’s CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma