Novartis' Kymriah, the World's First CAR-T Therapy, Granted Clinical Trial Approval in China for Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma

Original: Weiwei Yang

On October 30, the CDE website updated a list of clinical trials with implied approval, including Novartis’s star CAR-T therapy drug CTL019 (Tisagenlecleucel), indicated for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

On August 30, 2017, CTL019 (brand name: Kymriah) was approved by the U.S. FDA, becoming the first CAR-T drug to be marketed for the treatment of patients under 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed two or more times. Notably, this marks the first CAR-T therapy approved in human history and the first cell therapy approved by the FDA within the United States.

On May 1, 2018, Kymriah was approved for a second indication: the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had previously received two or more lines of systemic therapy.

The Insight Global New Drug Database shows that Kymriah is also undergoing clinical trials for indications such as non-Hodgkin lymphoma, follicular lymphoma, and multiple myeloma. Among these, the non-Hodgkin lymphoma indication recently approved in China has already progressed to Phase 3 clinical trials abroad.

On October 18, 2017, Kite Pharma’s CAR-T product Yescarta (axicabtagene ciloleucel, KTE-C19) was approved by the U.S. FDA for marketing, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Yescarta is the second CAR-T product approved globally and the first CAR-T product indicated for the treatment of non-Hodgkin lymphoma.

Currently, neither of the two CAR-T products has been approved in China. According to the Insight database (https://db.dxy.cn), there are eight companies conducting clinical trials of CAR-T therapies in China, with the most advanced candidate having entered Phase II clinical trials.

In March 2018, Nanjing Legend Biotech Co., Ltd. officially received the clinical trial approval from the former China Food and Drug Administration (CFDA) for LCAR-B38M CAR-T cell therapy for autologous infusion, marking the first approval of a CAR-T therapy clinical trial application in China.

According to the Insight database, CAR-T therapies from 12 companies have been approved for clinical trials (including Novartis’s CTL019), while CAR-T therapies from another 25 companies are currently under application for clinical trial approval.

According to survey data, the global CAR-T cell therapy market was valued at $167 million by 2018. Coherent Market Insights predicts that from 2018 to 2028, the global CAR-T cell therapy market will grow at a compound annual growth rate (CAGR) of up to 46.1%. However, with the advancement of CAR-T-related policies in China and increased R&D efforts, more companies are entering the CAR-T industry. China is expected to overtake competitors in the near future and capture a significant share of the global market.