On July 18, 2023 Fosun Kite Biotechnology Co., Ltd., jointly established by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma of the United States reported that Yikaida used for the treatment of adult large B-cell lymphoma (r/r LBCL) ("this new indication") who failed first-line immunochemotherapy or relapsed within 12 months conditionally approved by the State Drug Administration ("NMPA") (Press release, Fosun Kite Biotechnology, JUL 18, 2023, View Source [SID1234633299]). This also marks the official launch of Yikaida for second-line indication.
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Previously, there was no CAR-T cell therapy product in China for the treatment of adult large B-cell lymphoma who failed to respond to first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy. Fosun Kite’s Yikaida added a second-line indication. The approval for marketing of the drug has successfully promoted new progress in the treatment of adult large B-cell lymphoma, bringing hope to more patients who have failed or relapsed with first-line immunochemotherapy. At the same time, Yikaida is currently the first approved CAR-T cell therapy product in China for this new indication.
Professor Ma Jun from the Harbin Institute of Hematology and Oncology said, "The latest research shows that the incidence of lymphoma in China is increasing year by year. How to improve the prognosis of lymphoma treatment and improve the clinical cure rate has attracted the attention of the industry. If innovative therapy is limited to the later line, the curative effect will be discounted, and the patient’s benefit will be limited."
One of the shareholders of Fosun Kite, Kite, the global cell therapy leader, its ZUMA-7 study is the first head-to-head challenge salvage chemotherapy + autologous transplantation for LBCL patients with primary refractory or recurrence within 12 months after first-line treatment in the past 30 years, A large international multicenter RCT study. Based on Kite’s ZUMA-7 study, Axi-cel was approved by the FDA in April 2022 for the treatment of adults with LBCL who are refractory or have relapsed within 12 months of first-line treatment. The OS data of ZUMA-7 was announced at the American ASCO (Free ASCO Whitepaper) meeting in June this year. The median follow-up time was 47.2 months. The Axi-cel group did not reach the median OS, while the standard treatment (SOC) group was 31.1 months, and the HR value was 0.726, that is to say, the second-line use of Kite’s Axi-cel CART product reduced the risk of death by 27%.
"Lymphoma patients benefit from early use of CART therapy. All cancer drugs start from the end-line indications, and, after they are approved, continue to advance to the approval of second-line or first-line indications. It is because the treatment port can be brought forward. This is the law of new drug research and development." Professor Ma Jun said.
"China’s pharmaceutical industry is booming, and it is trying to innovate from multiple dimensions, from enterprises to supervision. The rapid approval of Yikaida as a second-line treatment for LBCL indications in China is a new milestone in the field of CAR-T cell therapy. The good news for lymphoma patients in China, and we look forward to bringing benefits to more patients." Professor Ma Jun said, "Axi-cel is the first choice for second-line treatment for patients with primary refractory or early relapsed LBCL, and it will greatly increase the cure rate. Significantly prolonging the Event-free survival (EFS) and OS of patients is a major therapeutic breakthrough in the field of lymphoma and will become the second-line standard treatment for applicable patients."
Yikaida has benefited more than 500 patients in the two years since its launch.
Adult large B-cell lymphoma (LBCL) is a common malignant lymphoma, accounting for about 30-40% of non-Hodgkin’s lymphoma. It has the characteristics of few treatment options, rapid disease progression, high mortality, and a short survival period. In recent years, the incidence rate in China has shown a rapid growth trend. In June 2021, Fosun Kite took the lead in launching the first domestic CAR-T cell therapy product——Yikaida (阿基仑塞Injection), from June 2021 to now, with personalized customization, one-time treatment, more than 500 patients with relapsed/refractory large B-cell lymphoma have brought revolutionary new breakthroughs in the field of cancer treatment in China.
On June 5, 2023, the ASCO (Free ASCO Whitepaper) annual meeting and the "New England Journal of Medicine" respectively introduced the main overall survival of the global multi-center phase III randomized controlled study ZUMA-7 (Kite’s MRCT study) in the form of oral reports and full-text releases. Period (OS) analysis results. When the median follow-up time was 47.2 months, compared with the second-line standard of care (SOC), 阿基仑塞 significantly improved the OS of patients, and the risk of death was reduced by 27.4%. It is worth mentioning that 57% of the patients in the SOC group received cell therapy in the third line or later. In this case, the median OS of the SOC group has been greatly improved, but the OS difference between the two is still statistically positive, which is very exciting.
"We are very happy to hear this good news, which indicates that Chinese patients can receive earlier treatment, which benefits patients and families," said Ms. Mei Jingping, Chairman of Fosun Kite.
Vice Chairman of Fosun Kite, Mr. Mert Aktar, commented, "This is a great milestone, and we believe it will benefit more Chinese patients, and bring hope to both patients and their families!"
Huang Hai, CEO of Fosun Kite, said: "Yikaida has treated more than 500 patients with relapsed/refractory large B-cell lymphoma since the second anniversary of its launch. With its excellent real-world curative effect, stable drug quality control, and continuous improvement. The availability of medicines has been highly recognized by the public. Here, we would like to express our gratitude and heartfelt thanks to the experts, scholars, and patient families and our Shareholders, Fosun Pharmaceutical (Group), and Kite Pharma, for their trust and support of Fosun Kate and Yikaida.
The approval of the new second-line indications of Yikaida is a key step taken by Fosun Kate and its shareholders to address China’s major unmet medical needs of lymphoma patients, and it is also a key step for China’s drug review and approval bureau. For the great efforts in the approval and supervision of innovative drugs, we would like to express our sincere gratitude to the government departments and regulatory agencies for their care and guidance at the glorious moment when new indications are approved!
To reach further & higher, we still need to make strides. Standing at the new starting point of the second anniversary of Yikaida’s commercialization, we look forward to Yikaida being able to cure more patients and improve their wonderful lives!