Yscarta Terapy: A Groundbreaking CAR-T Treatment for Aggressive Lymphomas
Yescarta therapy: A Groundbreaking CAR-T Treatment for Aggressive Lymphomas
CAR-T cell therapy is a revolutionary form of cancer treatment that harnesses the power of the patient’s own immune system to fight against cancer cells. It involves genetically modifying T cells (a type of immune cell) to express a chimeric antigen receptor (CAR) that targets a specific protein on the surface of cancer cells. These modified CAR-T cells are then infused back into the patient, where they can recognize and eliminate cancer cells.
YESCARTA: A Game-Changer in the Treatment of Aggressive Lymphomas
FDA Approval and Indications
On October 18, 2017, the U.S. Food and Drug Administration (FDA) approved YESCARTA (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. This groundbreaking approval marked YESCARTA as the second CAR-T cell therapy approved for cancer treatment worldwide.
Further expanding its indications, on March 5, 2021, the FDA approved YESCARTA for the treatment of adults with R/R follicular lymphoma (FL) after two or more lines of systemic therapy. This approval provided a new treatment option for patients battling this challenging form of non-Hodgkin’s lymphoma.
Introduction to China and Product Name
On June 22, 2021, YESCARTA was introduced to the Chinese market under the commercial name “阿基仑赛注射液” (Ajilunsai Zhushuyeye), bringing hope to patients in China suffering from these aggressive forms of lymphoma.
Mechanism of Action
YESCARTA is designed to recognize and target the CD19 protein, a transmembrane glycoprotein expressed on the surface of B cells and retained by most B-cell malignancies. The key components of the CAR construct in YESCARTA are the CD3-zeta and CD28 T-cell activation domains, which enable the modified T cells to recognize and eliminate CD19-expressing cells.
Clinical Data and Efficacy
ZUMA-7 Trial for R/R LBCL
In 2017, the pivotal Phase 3 ZUMA-7 trial was initiated, marking the largest randomized Phase 3 study of a second-line CAR-T cell therapy globally. The trial enrolled 359 patients across 77 centers worldwide.
In April 2022, the FDA reported the ZUMA-7 Phase 3 clinical data, which demonstrated an overall response rate (ORR) of 83% and a complete response rate (CR) of 65%. The incidence of cytokine release syndrome (CRS) was 92% (7% with grade ≥3), and the incidence of neurological toxicity was 74% (25% with grade ≥3).
ZUMA-1 Trial: 5-Year Follow-Up
In the 5-year follow-up assessment of the Phase 2 ZUMA-1 trial, the overall survival rate (OS) was 42.6%. Remarkably, 92% of the surviving patients at 5 years did not require additional cancer treatment, suggesting the possibility of a complete cure.
Pricing and Accessibility
Global Pricing: YESCARTA is priced at approximately $256,000 per dose globally.
Chinese Pricing: In China, the product name “阿基仑赛注射液” (Ajilunsai Zhushuyeye) is priced at approximately ¥120,000 per dose.
Conclusion
YESCARTA represents a paradigm shift in the treatment of aggressive lymphomas, offering hope to patients who have exhausted other treatment options. With its remarkable clinical efficacy and potential for long-term remission or even cure, this CAR-T therapy has revolutionized the landscape of cancer care. As access to YESCARTA expands globally, including its introduction in China, more patients can benefit from this groundbreaking treatment, providing them with a chance to overcome these challenging malignancies.