Researchers from the Office of Clinical Evaluation of Biological Products, Center for Drug Evaluation, China Food and Drug Administration recently produced a report titled “The Landscape of Car T-cell Therapy in the United States and China: A comparative analysis,” published in the International Journal of Cancer.
China has rapidly emerged as a viable center of novel innovation in cancer research and development. Three of the four authors work for the Chinese regulatory authority and hence posses a strategic perspective on the emergence of this new class of treatment as it unfolds in both critically important countries.
Introduction to the Research
They note that clinical trials of CAR T-cell therapy are rapidly growing in both the United States and China. They emphasize that exhibiting the distinctions between the clinical trials in the two countries is of great value for understanding the panorama of CAR T-cell clinical trials and forecasting the future of this promising therapy.
The authors analyzed the critical elements of 289 clinical trials posted on the Clinicaltrials.gov website by sponsors from the two countries—they evaluated the efficacy data in the available 50 published CAR T-cell studies.
Their analysis evidences that China has become the country with the largest number of CAR-T cell clinical trials by the end of 2017, while overall subject sample size and study center numbers are still larger, and the design of the clinical trials is more cautious in the United States.
Considerable distinctions between the two very different nations impact clinical trials from a historical and cultural perspective, not to mention legal and regulatory frameworks and the like.
Although presently available response rates look promising in both countries, it is inexpedient to conclude that clinical efficacy is comparable between the two countries considering the small patient sample size and discrete distribution of median cell doses in China. Finally, the regulatory regime of cell therapy in China, which expedites the bursting of CAR T-cell therapy, is also introduced and analyzed in this study.
For those interested in CAR T-cell clinical research in both China and the United States, this represents an interesting read. For those seeking to understand why China is so rapidly gaining and surpassing the United States in certain data points, this research should be included in a bibliography of references.
Chenyan Gao, Office of Clinical Evaluation of Biological Products, Center for Drug Evaluation, China Food and Drug Administration, Beijing, China