AstraZeneca halts Phase III Truqap trial for prostate cancer due to futility
AstraZeneca is discontinuing the CAPItello-280 Phase III trial of Truqap (capivasertib) in metastatic castration-resistant prostate cancer. An interim analysis suggests the combination therapy is unlikely to meet its primary endpoints.
AstraZeneca has announced the discontinuation of its CAPItello-280 Phase III clinical trial, which was evaluating the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) for patients with metastatic castration-resistant prostate cancer (mCRPC).
The decision was made following a recommendation from the Independent Data Monitoring Committee (IDMC). After reviewing data from a pre-specified interim analysis, the committee concluded that the Truqap combination was unlikely to meet the trial's dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) upon completion.
The safety profile of Truqap in the trial was found to be consistent with previous studies. The company will work with investigators to ensure appropriate patient follow-up, and data collected will inform ongoing research in mCRPC. The trial involved 1,033 adult patients.
Metastatic castration-resistant prostate cancer remains a significant challenge in oncology, with a high unmet medical need despite recent treatment advancements. The discontinuation highlights the difficulties in developing new therapies that can significantly extend survival in this advanced stage of the disease.