Source: Xinmin Evening News

Speaking of the most popular cancer treatment in recent years, chimeric antigen receptor T cell (CAR-T) in immunotherapy is definitely one of the focus areas. Since its launch in China, has CAR-T cell therapy helped patients achieve long-term survival? What does it mean for CAR-T cell therapy to be approved for use as a second-line treatment? At the 3rd China Lymphoma Patients Conference held two days ago, Fosun Kite presented its star product of the newly approved second-line indication CAR-T cell therapy – Yi Kai Da (ejilunsai injection), and two patients who achieved long-term survival after receiving CAR-T cell therapy shared their treatment experience.

Ms. Qin, who was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2017, went through 12 rounds of chemotherapy, however, chemotherapy did not keep her condition under control. She then became the first patient enrolled in the clinical trial of Fosun Kite’s CAR-T cell therapy and was miraculously cured by Yi Kai Da. Since then, she has been living healthily for more than five years. The five-year or even longer survival signals "cancer-free", which implies that CAR-T cell therapy is reshaping the treatment landscape of DLBCL. Ms. Qin brought hope to every lymphoma patient and family member with her own personal experience.

"We share almost the same feelings, from the anxiety of being diagnosed with lymphoma, the despair and helplessness after chemotherapy failure, to the joy of being cured." Another patient, Mr. Wang, who is cured of lymphoma by Yi Kai Da, also smiled with tears. He once struggled with relapse after chemotherapy, but fortunately, he has bid farewell to cancer thanks to the world's most advanced CAR-T cell therapy. What is more gratifying is that the cost of treatment has been greatly reduced because he enrolled in an insurance plan. He did not have to worry about the cost.

The cured cases and sincere sharing of the two patients aroused widespread recognition from clinical experts, medical insurance experts and other guests at the conference, especially among the representatives of patients. Through the real cases of using Yi Kai Da to achieve long-term survival, Ms. Qin and Mr. Wang shared that lymphoma is in fact a curable disease. We should have firm confidence and maintain apositive attitude towards treatment.

At the conference, not only the real cases of two long-term surviving patients wereinspiring, but the latest development of Yi Kai Da also attracted great attention. On 21 June, the marketing registration application of Yi Kai Da for the treatment of adult patients who have failed first-line immunochemotherapy or relapsed large B-cell lymphoma (r/r LBCL) within 12

months after first-line immunochemotherapy was officially approved by the National Medical Products Administration (NMPA), which means that Yi Kai Da will help more lymphoma patients seize the best treatment opportunity, receive CAR-T cell therapy earlier, and gain more hope for cure.

Professor Li Ping from the Department of Hematology of Tongji Hospital in Shanghai said in the interactive session that, "The approval of CAR-T cell therapy for second-line treatment not only means that patients can start the treatment earlier, but also implies better efficacy, safer treatment, and lower incidence of adverse reactions. It can also prevent patients from being unable to receive infusion due to the decline in the function of T cells required for CAR-Tcelltherapy and the rapid growth of tumor resulting from many rounds of chemotherapy. Early detection and early treatment increase the chance of cure.

At present, approximately 40% of DLBCL patients develop relapsed/refractory DLBCL after initial standard treatment, leading to significant mortality. In recent years, the Department of Hematology of Tongji Hospital has accumulated extensive experience in CAR-T cell therapy. Professor Li Ping told reporters that CAR-T cell therapy was generally used after third- and fourth-line treatment previously, however, if a patient has tried a variety of treatments and used many drugs before receiving CAR-T cell therapy, the efficacy of CAR-T cell therapy may fall short of expectations. Clinical studies at home and abroad have discovered that using CAR-T cell therapy as the second-line treatment can achieve better survival than standard chemotherapy, and it is believed that CAR-T cell therapy will be used in earlier stage in the future. "With the breakthrough of CAR-T cell therapy in the treatment of refractory and relapsed hematological tumors, and the clinical treatment of adverse reactions has become more and more mature, CAR-T cell therapy is expected to become the main force in the treatment of hematological tumors."

Many patients wonder how CAR-T cell therapy works and which types of patients are eligible for CAR-T cell therapy. In this regard, Professor Li Ping said that compared with previous drug therapies, CAR-T cell therapy is more complex and there are generally 6 steps involved in it, namely patient screening, T-cell collection, CAR-T cell preparation, amplification, infusion and monitoring. Patients with relatively high tumor burden or fast-growing cancer or poor overall immunity are generally not suitable for immediate CAR-T cell therapy.

CAR-T products currently on the market in China all target CD19 for hematological tumors. CD19 is highly expressed on B cell-related leukemia and lymphoma cells, but less expressed on normal B cells. Therefore, related CAR-T products have good therapeutic effect. However, CAR-T cell therapy is also affected by factors such as the patient's genotype, immune system, and condition. Therapeutic effect varies from person to person. After receiving CAR-T cell therapy, approximately 40% of patients can achieve long-term remission, while some patients may still relapse, follow-up is essential for early detection and early treatment. However, based on the current clinical evidence, CAR-T cell therapy has significantly improved the remission rate and overall survival of patients with hematological cancer.

Dr. Zhao Jinghua, Chief Medical Officer of Fosun Kite, said that in June this year, the interim analysis of the real-world data of Yi Kai Da for the treatment of large B-cell lymphoma (LBCL) in Chinese patients were presented at the European Hematology Association (EHA) and International Conference on Malignant Lymphoma (ICML) conferences. The data showed that the efficacy in the Chinese population is consistent with that of the rest of the world, with better safety, providing first-hand evidence-based medicine for Chinese doctors in the treatment of lymphoma.

Since Yi Kai Da was launched in China in June 2021, Fosun Kite has improved the accessibility of high-quality and reliable CAR-T cell therapy through diversified innovative payment solutions. At present, Yi Kai Da has been successfully included in more than 60 commercial health insurances, and urban customized commercial health insurance of more than 90 provinces and municipalities, and several patient welfare plans have also been put in place.