JW Therapeutics’ CAR-T Approval in China Comes On the Heels of its Rival

JW Therapeutics, a joint venture between Juno Therapeutics (a Bristol-Myers Squibb Company) and WuXi AppTec, has won approval from China’s National Medical Products Administration (NMPA) for their first anti-CD19 CAR-T product relmacabtagene autoleucel (relma-cel).

Relma-cel is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after they have received at least two lines of systemic therapy. The drug is the second CAR-T therapy to reach the Chinese market, after Fosun Kite’s Yescarta.

Reliance Study Proves Relma-cel’s Reliability

JW has their single-arm, multi-center Reliance study to thank for the approval. The Phase 2 study, which enrolled 59 patients with r/r LBCL, showed that relma-cel treatment stimulated a good response in a high proportion of the patients; the drug also had a favorable safety profile.

As of last June, the best overall response rate of 58 evaluable patients was 75.9%, meaning that many percent of patients responded to relma-cel at any time point during the study. The best complete response rate was 51.7%.

For serious adverse events above Grade 3, 5.1% of the patients experienced cytokine release syndrome, while 3.4% experienced neurotoxicity. Those are considered common side effects of CAR-T therapy.

Extension Of a Rivalry

In terms of speed, JW has come second in the race as Fosun Kite’s Yescarta was the first CAR-T drug to be approved in China to treat patients with the same type of cancer. Fosun Kite is a joint venture by Gilead Sciences’ Kite Pharma and Shanghai Fosun Pharmaceutical. Both Yescarta and JW’s relma-cel target CD19 but are different in their manufacturing process.

The fact that both drugs used similar technology has landed Kite in hot water. Juno and Kite had been embroiled in a legal battle since 2017, with the former alleging that Kite had ripped off its licensed patent to develop Yescarta. 

In a latest development, a US federal court overturned a $1.2 billion fine against Kite last month, reversing what was previously seen as early victories for Juno.

Author

Joy Lin

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