The NMPA has approved Calquence (BTK inhibitor) for adult patients with MCL. The approval was based on the 2 clinical trials, incl. the P-II trial (ACE-LY-004) for adults with r/r MCL & P-I/II trial in Chinese patients with r/r MCL & other B-cell malignancies evaluating Calquence (100mg)
In the P-II trial, the results showed ORR (80.6%) at a median follow-up of 15.2mos. with a CR (39.5%) while the long-term follow-up data showed that patients remained progression-free for a median of 22mos. @38.1mos., m-OS of 59.2mos.
In the P-I/II trial, ORR (82.4%), CR (35.3%), and 51.5% reduction in risk of disease progression or death at 12mos. with an estimated DoR of 65.5% & the m-DoR (not reached). The safety & tolerability were consistent with prior reported trials
Ref: AstraZeneca | Image: AstraZeneca
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