Gilead’s Yescarta Becomes First CAR-T Therapy to Score Regulatory Approval in China

by Tyler Chen
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China broke the status quo by approving the country’s first CAR-T therapy on June 23rd. Fosun Kite Biotechnology, the joint venture of Kite Pharma and China’s Fosun Pharmaceutical, received approval from the NMPA for Yescarta(axicabtagene ciloleucel) to treat adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

Other indications include diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.


Score Regulatory win in China After FDA, EMA Approvals

Developed by Kite, the subsidiary of Gilead, Yescarta was transferred to Fosun Kite in 2017 for approval and clinical trials in China. The drug was quite successful in bagging regulatory approvals and was the first CAR-T therapy to be approved in the world. It won the FDA and EMA approvals in 2017 and 2018, respectively.


The Phase 1/2 Bridging Trial

NMPA’s nod came from a single-arm Phase 1/2 bridging trial FKC876-2018-001, which evaluated the efficacy and safety of Yescarta in Chinese patients with refractory intermediate invasive non-Hodgkin’s lymphoma (NHL)/ large B-cell lymphoma.

Not all of the trial data were revealed. However, according to the Chinese Clinical Trial Registry, the sample size was 15, and the trials were conducted in 3 locations, including hospitals in Shanghai, Wuhan, Hubei, and Suzhou, Jiangsu. The primary endpoints constituted examining the incidence of dose limiting toxicity and overall response rate.


Drug Response in Patients After 3 Years

In December 2017, Kite published the results of the ZUMA-1 trial, demonstrating that Yescarta reached 83% of the overall response rate in 101 refractory large B-cell lymphoma patients after being treated for 2 years. What’s more, 58% of patients have achieved a complete response.

Later, Kite found that 42% of patients remained in response, including 40% in complete remission after a median of 15.4 months post-infusion. In a median of 27.1 months post-infusion, 39% of patients remained in response, including 37% in complete remission.


Current CAR-T Therapy Status

At present, a total of five CAR-T therapies have been approved by the US FDA, including Abecma and Breyanzi by BMS, Tecartus and Yescarta by Gilead, and Kymriah by Novartis.

BMS is the only company with two CAR-T therapies with different targets of CD19 and BCMA, while Gilead’s CAR-T therapies solely target CD19.

BMS and Bluebird’s Abecma is the latest CAR-T therapy to be approved by the FDA, getting the nod in March 2021.

Related Article: China’s Legend Biotech to Build a CAR-T Therapy Production Site in Belgium


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