Recently, Yescarta has been officially approved by the China NMPA for second-line treatment. It is now indicated for adult patients with large B-cell lymphoma (LBCL) who have not responded to first-line immunochemotherapy or have relapsed within 12 months after first-line treatment. Yescarta has started to be prescribed in hospitals across the country, providing new hope for patients who are resistant to or have relapsed after first-line therapy.
LBCL is the most common type of adult non-Hodgkin lymphoma and represents about 40% of non-Hodgkin lymphoma cases, being a highly heterogeneous malignancy in the hematologic tumor category. Approximately 40% of patients experience disease progression or relapse after first-line treatment, particularly those with primary refractory disease or early relapse, leading to an urgent need for innovative treatments to improve patient survival.
As an innovative therapy in hematologic oncology, Yescarta’s clinical efficacy has been validated by robust evidence. A recent multi-center real-world study showed that the real-world efficacy of Yescarta for relapsed or refractory non-Hodgkin lymphoma patients in China is consistent with global findings, reporting a 12-month overall survival rate of 84.3%, a best overall response rate of 83.2%, and a best complete response rate of 58.4%, with improved safety profiles.
In June 2021, Yescarta received approval for its first indication in China for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. It has since benefited over 500 patients and gained high public recognition. The recent approval for second-line indications makes Yescarta the first CAR-T therapy in China to receive this indication, marking a significant milestone in lymphoma treatment and indicating that more patients will benefit from this innovative therapy.
Professor Ma Jun, Director of the Harbin Institute of Hematology and Oncology, stated, “In the field of hematologic oncology, monoclonal antibodies emerged in 1997, small molecule targeted drugs in 2001, and CAR-T therapy in 2012. These new treatment modalities have been introduced to China, greatly improving the diagnosis and treatment of blood diseases and achieving successive breakthroughs in cure rates. Yescarta was the first commercial CAR-T approved in China in June 2021, bringing hope for curing relapsed or refractory large B-cell lymphoma. With the recent approval for its second-line indication, Yescarta will undoubtedly provide new hope for more lymphoma patients and advance the development of cell therapies in China.”
Professor Wu Depai, Director of the Hematology Department at the First Affiliated Hospital of Suzhou University, remarked, “As both global and Chinese research on refractory LBCL progresses, the treatment options and drugs available for clinical selection are continuously increasing. With the development of personalized treatment for lymphoma and various treatment combinations, along with new CAR-T-based therapies, the cure rate and long-term survival of lymphoma patients have improved.”
Professor Zhao Weili, Vice Dean of Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, added, “Since its launch as China’s first commercial CAR-T in June 2021, Yescarta has benefited over 500 lymphoma patients through two years of clinical practice. With the collaborative efforts of Chinese hematology experts, the first real-world data on CAR-T in China was published internationally in June 2023, filling a gap in real-world research. The results demonstrated consistent efficacy with international data, with better safety profiles, showcasing China’s expertise in personalized CAR-T management. The approval of Yescarta’s second-line indication again represents a breakthrough in cell therapy. I believe that with the leadership of Chinese hematology experts, continuous clinical practice will yield more CAR-T treatment experiences, benefiting more lymphoma patients and driving new milestones in China’s cell therapy field.”
Currently, hospitals such as Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital, Sun Yat-sen University Cancer Center, First Affiliated Hospital of Zhengzhou University, and First Affiliated Hospital of University of Science and Technology of China have begun prescribing Yescarta for second-line treatment. Fosun Kite is also working to include Yescarta in over 60 commercial health insurance plans and more than 80 city-level “benefit insurance” programs. They have launched several patient welfare initiatives, including the “Worry-Free Medication Benefit Plan” for second-line patients and the “Yiqi New Life” program for third-line patients, addressing various concerns such as adverse reaction protection, medication progress assurance, death benefits, and financial loans.
