Company: AZN
Filing Date: 2025-04-29
Form Type: 6-K
Source: 0001654954-25-004742
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-04-29
Form: 6-K
Chunk 1
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 endpoints ofradiographic progression-free survival (rPFS) and overall survival (OS) 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.

#### Notes

#### Prostate cancer
Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and over 397,000 deaths in 2022. 1

Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis. 2Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. 3

Metastatic castration-resistant prostate cancer

Approximately 10-20% of men with advanced prostate cancer will develop castration-resistant prostate cancer within five years. 4 In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones. 3 At least 84% of these men will have metastases at the time of CRPC diagnosis and, of those patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years. 4 Approximately half of patients with mCRPC may receive only one line of active treatment, and those that go on to receive further treatment often have diminishing benefit of subsequent therapies. 5-6

Despite the advances in mCRPC treatment with taxane and new hormonal agent treatments, there is high unmet need in this population. 4,7,8

#### CAPItello-280
CAPItello-280 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with docetaxel and ADT compared to docetaxel and ADT in combination with placebo in patients with mCRPC.

The global trial enrolled 1,033 adult patients with histologically confirmed prostate adenocarcinoma with evidence of mCRPC with progression of disease despite ADT. The dual primary endpoints of the CAPItello-280 trial are rPFS as assessed by investigator and OS in the overall trial population. Key secondary endpoints include OS and rPFS as assessed by investigator in patients with mCRPC and