Axi-Cel Expands LBCL Indication in China


The CAR T-cell therapy, marketed as Yikaida in China, has been approved for second-line treatment for patients with refractory/relapsed large B-cell lymphoma.

Axicabtagene Ciloleucel (axi-cel), marketed under the name Yikaida (Fosun Kite Biotechnology, Kite Pharma) in China, has been approved in the country under an expanded indication, for the treatment of adult patients with large B-cell lymphoma (r/r LBCL) whose disease did not respond to first-line immunochemotherapy or relapsed within 12 months.1

"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,” Professor Ma Jun, Harbin Institute of Hematology and Oncology, said in a statement.1 “If innovative therapy is limited to the later line, the curative effect will be discounted, and the patient's benefit will be limited."

Yikaida is the first approved chimeric antigen receptor (CAR) T-cell therapy in China for the second-line treatment of r/r LBCL. Most recently, new overall survival data from the phase 3 ZUMA-7 clinical trial (NCT03391466) conducted in the US demonstrated the benefit of axi-cel compared to the standard of care in this indication.

"Lymphoma patients benefit from early use of CAR-T 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.” Ma Jun said.1

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The survival data were presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, held June 2-6, in Chicago, Illinois, by Jason Westin, MD, director, lymphoma clinical research, and section chief, aggressive lymphoma research team, Unviersity of Texas MD Anderson Cancer Center.

ZUMA-7 randomized 180 patients with LBCL to the axi-cel arm and 179 to the SOC arm. At a median follow-up of 47.2 months, axi-cel treatment improved overall survival (OS) with a hazard ratio [HR] of 0.726 (95% CI, 0.540-0.977; one-sided = .0168).2 Median OS was not reached in the axi-cel arm and was 31 months in the SOC arm. This is an improvement from historical studies of survival with SOC treatment, including the ORCHARRD study (NCT01014208), which yielded a 10-month median OS. Investigators also found that the axi-cel arm had a 4-year OS rate of 54.6% compared with 46.0% in the SOC arm.The data represent a 27.4% reduction in the risk of death, even with over half of SOC patients receiving subsequent cellular immunotherapy. The survival benefit was seen across all assessed subgroups and the axi-cel arm had a similar benefit in progression-free survival (PFS) over the follow-up period

"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,” Ma Jun added.1 "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 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."

1. Yikaida CAR-T cell therapy approved as a second-line therapy for new indication. July 18, 2023. News release. Fosun Kite Biopharmaceuticals.
2. Westin J, Oluwole OO, Kersten MJ, et al. Primary overall survival analysis of the phase 3 randomized ZUMA‑7 study of axicabtageneciloleucel versus standard‑of‑care therapy in relapsed/refractory large B-cell lymphoma. Presented at: ASCO 2023 Annual Meeting; June 2-6; Chicago, Illinois. Abstract #LBA107
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