Good news for lymphoma patients! CAR-T Cell Therapy Product Second Line Indications Approved for Market in Lymphoma | Cells | CAR
The reporter learned from Fosun Pharmaceuticals today that its joint venture company, Fosun Kate, has developed Aquilense Injection for the treatment of adult B-cell lymphoma that is ineffective in first-line immunochemotherapy or relapses within 12 months after first-line immunochemotherapy. The registration application has been conditionally approved by the National Medical Products Administration, marking the launch of this CAR-T cell therapy product as a second-line indication.
Adult large B-cell lymphoma is a common malignant lymphoma, accounting for 30% -40% of non Hodgkin's lymphoma. It has the characteristics of few treatment plans, rapid disease progress, high mortality, and short survival period. In recent years, the incidence of incidence rate in China has shown a rapid growth trend. In June 2021, Aquilense Injection became the first CAR-T cell therapy product approved for sale in China, used to treat adult patients with recurrent or refractory large B-cell lymphoma who have previously received second-line or above systemic treatment.
As of now, this personalized and one-time treatment cell drug has benefited over 500 patients with relapsed/refractory large B-cell lymphoma, bringing technological breakthroughs to cancer treatment in China.
Fosun Kate researchers are conducting CAR-T cell analysis research.
Fosun Medical experts introduce that CAR-T therapy is an individualized treatment method that utilizes the human body's own immune system. Technicians extract T cells from patients through white blood cell isolation and modify them with chimeric antigen receptors, allowing T cells to recognize specific antigens on cancer cells and respond accordingly. After completing the genetic engineering modification, technicians transfused CAR-T cells back to the same patient.
This month, the annual meeting of the American Society of Clinical Oncology and the New England Journal of Medicine presented the main overall survival analysis results of a global multicenter phase III randomized controlled study in both oral and full-text formats. At a median follow-up time of 47.2 months, compared to second-line standard treatment, Agilensei significantly improved patient OS and reduced the risk of mortality by 27.4%.
According to the introduction, 57% of patients in the SOC group received cell therapy on or after the third line after leaving the group. In this situation, the median OS of the SOC group has significantly increased, but the statistical difference in OS between the two groups still achieved positive results, which is encouraging.
Previously, there were no CAR-T cell therapy products available in China for the treatment of adult large B-cell lymphoma that was ineffective in first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy. The approval and launch of the new second-line indications for Yikaida has achieved new progress in the treatment of adult large B-cell lymphoma, bringing hope to patients who have failed or relapsed first-line immunochemotherapy.