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Astra accelerates as Acerand enters the PARP1 race

As AstraZeneca unveiled the second pivotal trial of its selective PARP1 inhibitor, saruparib, a new contender in this nascent mechanism entered the clinic. Acerand, a Chinese/US group, enrolled the first patient into a phase1/2 trial of its similarly acting asset, ACE-86225106. Development looks to be restricted to China for now, although the company claims to have global intentions. Notably the asset becomes only the sixth clinical-stage PARP1 inhibitor, according to OncologyPipeline. Astra is way out in front in this space, a lead consolidated by the start of Evopar-Breast01. The study, in advanced breast cancer, pits saruparib plus camizestrant (Astra’s novel SERD) against CDK4/6 inhibition and endocrine therapy. Astra has high hopes for both assets, but both are unproven so this could be viewed as a risky choice for saruparib’s second pivotal move. Encouraging data on saruparib’s performance versus Lynparza in breast cancer were presented recently. Interestingly, Evopar-Breast01 includes a third arm, trialling camizestrant plus CDK4/6 inhibition; this cohort will not inform the primary endpoint but could help add to the weight of evidence that the company is already amassing on camizestrant. The SERD’s own pivotal programme begins to read out in 2025. 


Astra's PARP1 pivotal plans take shape

Trial nameSettingExperimental armControl armNº of patientsPrimary endpointExpected data readout
Evopar-Prostate011L metastatic CSPC, includes HRRm and non-HRRm cohortsSaruparib + choice of NHAiPlacebo + choice of NHAi1,800rPFSJan 2028
Evopar-Breast01Advanced ER+/HER2- breast cancer, with BRCA1, BRCA2 and PALB2 mutationsSaruparib + camizestrantChoice of CDK4/6i plus endocrine therapy500PFSMar 2029
Choice of CDK4/6i plus camizestrant

Source: OncologyPipeline.


Molecular Drug Targets