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AstraZeneca's CAPItello-280 Trial Discontinued: Key Insights and Future Directions

$AZN
Form 6-K
Filed on: 2025-04-29
Source
AstraZeneca's CAPItello-280 Trial Discontinued: Key Insights and Future Directions

Key Information Extracted from the SEC Filing on CAPItello-280 Phase III Trial

Company Overview:

  • Name: AstraZeneca PLC
  • Headquarters: Cambridge Biomedical Campus, Cambridge, UK
  • SEC File Number: 001-11960
  • Form Submitted: Form 6-K

Trial Update:

  • Trial Name: CAPItello-280
  • Focus: 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).
  • Trial Status: Discontinued.
  • Reason for Discontinuation: Recommendation from the Independent Data Monitoring Committee (IDMC) based on a pre-specified interim analysis indicating that the combination therapy is unlikely to meet the dual primary endpoints of:
  • Radiographic Progression-Free Survival (rPFS)
  • Overall Survival (OS)

Trial Details:

  • Patient Enrollment: 1,033 patients with histologically confirmed prostate adenocarcinoma and evidence of mCRPC.
  • Primary Endpoints:
  • rPFS assessed by investigator
  • OS in the overall trial population
  • Secondary Endpoints: Include OS and rPFS in patients with PTEN-deficient and PTEN-proficient tumors, time to pain progression, and time to first symptomatic skeletal-related event (SSRE).

Treatment Background:

  • Truqap (capivasertib): A first-in-class, potent ATP-competitive inhibitor of AKT isoforms, administered at 400mg twice daily on an intermittent schedule.
  • Current Approvals: Truqap is approved for use in combination with Faslodex (fulvestrant) for HR-positive, HER2-negative breast cancer and is under evaluation for other cancers.

Market Context:

  • Prostate Cancer Statistics:
  • Second most prevalent cancer in men, with over 1.4 million new cases and 397,000 deaths globally in 2022.
  • Significant mortality associated with metastatic prostate cancer, with only one-third of patients surviving five years post-diagnosis.

Future Directions:

  • AstraZeneca will continue to work with trial investigators for patient follow-up and use the data from the CAPItello-280 trial to inform ongoing research and development efforts.

Conclusion: The discontinuation of the CAPItello-280 trial signifies a setback for the development of Truqap in treating mCRPC, reflecting the challenges faced in achieving clinical efficacy in this area. The company remains committed to addressing the high unmet medical need in advanced prostate cancer treatments.