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BeiGene's head-to-head test advances

BeiGene is wasting no time in the BTK degrader race against its rival Nurix, moving swiftly to start two new phase 3 studies of its project, BGB-16673. Most interesting of these is a trial in CLL patients who have previously been treated with a covalent BTK inhibitor, where BGB-16673 is going head to head against Lilly's non-covalent molecule Jaypirca. It's a key test of BTK degradation whether this approach is better than non-covalent BTK inhibition – itself supposedly superior to covalent BTK inhibitors, which are prone to downstream mutation escape. BeiGene already mooted the start of this head-to-head trial this year, and its just revealed clinicaltrials.gov entry specifies a start date of September. Also new is a phase 3 study of BGB-16673 versus investigator's choice in CLL patients after covalent BTK inhibitor treatment, complementing BGB-16673's first pivotal effort, also against investigator's choice but in patients pretreated with a BTK as well as a BCL2 inhibitor. For its part Nurix's BTK degrader bexobrutideg, which has impressed with efficacy on a par with BGB-16673, is to enter pivotal CLL studies this year, though for now none has been revealed.

 

Pivotal studies of BeiGene's BGB-16673 (all in CLL)

TrialSettingComparator cohortPrimary endpointTiming
NCT06846671Pretreated with BTKi & BCL2iInvestigator’s choicePFSStarted 10 Apr 2025
NCT06970743Pretreated with cBTKiInvestigator’s choicePFSStarts 2 Jun 2025
NCT06973187Pretreated with cBTKiJaypircaPFSStarts Sep 2025

Source: OncologyPipeline.

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