Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma Including Follicular Lymphoma

December 13, 2021 /BioValleyBIOON/ -- Gilead Sciences recently announced at the 63rd American Society of Hematology (ASH) Annual Meeting in 2021CD19 CAR-T Cell Therapy Yescarta (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma (r/r iNHL, Including Follicular Lymphoma [FL])Latest 2-Year Results from Phase 2 ZUMA-5 Study in Adult Patients.

It is worth mentioning that,Yescarta is the first CAR-T cell therapy to report 2-year data from the pivotal trial in r/r iNHLThe data presented at the meeting showed that, among all patients who received a single infusion of Yescarta,The overall response rate (ORR) reached 92%, with a complete response rate (CR) of 75%.In patients with follicular lymphoma (FL), 57% were in sustained remission at a median follow-up of 31 months.

ZUMA-5 (NCT03105336) is a global, multicenter, single-arm, open-label Phase 2 study enrolling adult patients (aged ≥18 years) with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL) subtypes. These patients had previously received at least two lines of systemic therapy, including a combination of an anti-CD20 monoclonal antibody and an alkylating agent. The objective of the study was to evaluate the efficacy and safety of a single infusion of Yescarta in this patient population.

At the data cutoff, 110 patients (86 FL patients, 24 MZL patients) were eligible for efficacy analysis. FL patients were followed up for at least 2 years, while the minimum requirement for MZL patients was a 4-week follow-up.In eligible FL patients, the median follow-up time was 30.9 months (range: 24.7-44.3),Objective Response Rate (ORR) was 94%, Complete Response Rate (CR) was 79%, 57% of patients showed sustained remission, with an estimated median duration of response (DOR) of 38.6 months, a median progression-free survival (PFS) of 39.6 months, a median time to next treatment of 39.6 months, and the median overall survival (OS) not yet reached; the estimated 24-month OS rate was 81%.

In eligible MZL patients, the median follow-up time was 23.8 months (range: 7.4-39.4),ORR was 83%, CR was 63%.At the data cutoff, 50% of patients were in ongoing remission. The median DOR and the median time to next treatment had not yet been reached, the median PFS was 17.3 months, the median OS had not yet been reached, and the estimated 24-month OS rate was 70%.

In all evaluable patients (n=149), safety observations were consistent with the known safety profile of Yescarta. ≥3 grade cytokine release syndrome (CRS) and neurological events occurred in 7% (6% FL; 8% MZL) and 19% (15% FL; 36% MZL) of patients, respectively. The majority of CRS cases (120/121) and neurological events of any grade (82/87) had resolved at the data cutoff.

Sattva S. Neelapu, M.D., Ph.D., Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, stated: "When treating patients with iNHL, including FL, we aim to reduce the frequency of relapses and delay progression to more aggressive disease. For these patients, relapse is most likely to occur within 2 years of treatment. Therefore, the data presented at this meeting...The 2-year results, with a high remission rate, a median PFS of nearly 40 months, and evidence of no progression events 2 years later, are very encouraging. Yescarta has the potential to redefine treatment for these patients.。”

Frank Neumann, M.D., Ph.D., Global Head of Clinical Development at Kite Pharma, a Gilead Sciences company: "The durable responses seen with a single infusion of Yescarta in this frequently relapsing patient population are impressive." "With these long-term data, we believe Yescarta is truly transformative for people living with indolent non-Hodgkin lymphomas, such as follicular lymphoma, and we are working to bring this therapy to patients around the world who may benefit."

Yescarta (Axicabtagene Ciloleucel, Axi-Cel) is a CD19 CAR-T cell therapy acquired by Gilead Sciences for $11.9 billion through the purchase of Kite. In the United States, Yescarta was approved in October 2017.FDAApproved, it is the first CAR-T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (R/R LBLC).

In March 2021, Yescarta was approved in China.FDAApproval of a new indication: for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have previously received two or more systemic therapies. Based on this latest approval, Yescarta is the first CAR-T cell therapy approved for the treatment of FL.

In China, this June, the National Medical Products Administration (NMPA) approved FOSUN Kite Biotechnology Co., Ltd.'s application through the priority review and approval process.Axicabtagene Ciloleucel Injection (Trade Name: Yikaida) Launched.This drug is the first cell therapy product approved for marketing in China, used to treat adult patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of systemic therapy (including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma).

Axicabtagene Ciloleucel Injection (Yikaida) is a localized production in China (excluding Hong Kong, Macao, and Taiwan) based on Kite Pharma's Yescarta (Axicabtagene Ciloleucel, Axi-Cel) through technology transfer.. This product was introduced by Fosun Kite from Kite Pharma and has obtained the technical and commercial rights in mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region.

This product is the first CAR-T cell therapy product that Fosun Kite has advanced to commercialization in China.，It is also the first CAR-T cell therapy product officially approved for marketing by the National Medical Products Administration (NMPA).. As a completely newTumorTreatment Method: Axicabtagene Ciloleucel Injection (Yikaida) Offers New Hope and Opportunities for Chinese Patients with Relapsed or Refractory Large B-Cell Lymphoma After Receiving Second-Line or Above Systemic Therapy. (Bioon.com)

Source of the original text:Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma Including Follicular Lymphoma