Bristol Myers Squibb’s CAR-T drug Breyanzi has a sister med on the market.
JW Therapeutics, a joint venture between Bristol Myers’ Juno Therapeutics and WuXi AppTec, has won approval in China for CD19 CAR-T cell therapy relmacabtagene autoleucel (relma-cel) to treat large B-cell lymphoma after at least two prior lines of systemic therapy.
Relma-cel marks China’s second approved CAR-T therapy. Fosun Kite Biotechnology, a joint venture between Fosun Pharma and Gilead Sciences’ Kite Pharma, claimed the first-to-market title in June with their approval for Yescarta in the same disease setting.
Just like the relationship between Kite’s two CD19 CAR-T products, Yescarta and Tecartus, relma-cel expresses the same CD19-targeting CAR construct as Breyanzi. The difference is that relma-cel uses a manufacturing process developed in China that doesn’t require separate CD4 and CD8 T-cell production trains, JW says.
In a single-arm, pivotal trial dubbed Reliance, relma-cel triggered a response in 75.9% of 58 evaluable patients at any time point during the study. Further, investigators saw no signs of cancer in 51.7% of patients throughout the study as of an analysis last June.
Among all 59 treated patients, only 5.1% and 3.4% experienced cytokine release syndrome and neurological toxicity, respectively, at grade 3 or above. The two side effects are commonly linked to CAR-T treatments. In a Friday statement, JW said relma-cel’s high response rates and low rates of CAR-T-related side effects “may provide a best-in-class CAR-T therapy profile.”