AstraZeneca (AZN) is discontinuing the CAPItello-280 Phase III trial evaluating the efficacy and safety of Truqap in combination with docetaxel and androgen-deprivation therapy, ADT, compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer, mCRPC. This decision is based on the recommendation of the Independent Data Monitoring Committee, IDMC, following their review of data from a pre-specified interim analysis, which concluded that the Truqap combination was unlikely to meet the dual primary endpoints of radiographic progression-free survival, rPFS, and overall survival versus the comparator arm upon trial completion. The safety profile for Truqap was consistent with previous trials. The Company will work with investigators to ensure the necessary follow up with patients. Data from the trial will inform ongoing research.
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