Capivasertib plus abiraterone in PTEN-deficient de novo metastatic hormone-sensitive prostate cancer: updated survival analysis from CAPItello-281☆
Annals of Oncology, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Basım Tarihi: 2026
- Doi Numarası: 10.1016/j.annonc.2026.10.097
- Dergi Adı: Annals of Oncology
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, MEDLINE, Academic Search Ultimate (EBSCO), Biomedical Reference Collection: Corporate Edition (EBSCO), Health Research Premium Collection (ProQuest), Pharma Collection (ProQuest)
- Anahtar Kelimeler: abiraterone, CAPItello-281, capivasertib, mHSPC, prostate, PTEN
- Ankara Üniversitesi Adresli: Evet
Özet
Background: Patients with phosphatase and tensin homolog (PTEN)-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) have poor prognosis and reduced benefit from current standard of care. The phase III CAPItello-281 study (NCT04493853) showed a statistically significant benefit in radiographic progression-free survival (rPFS) with capivasertib plus abiraterone versus placebo plus abiraterone (combined with prednisone/prednisolone and androgen deprivation therapy): hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.66-0.98; P = 0.034. The HR for interim overall survival (OS; 26% maturity) was 0.90, 95% CI 0.71-1.15. Here, we report ad hoc, descriptive analyses at 42% OS data maturity. Patients and methods: Patients with de novo mHSPC and PTEN-deficient tumors (defined as ≥90% of viable malignant cells with no specific cytoplasmic staining by immunohistochemistry) received capivasertib plus abiraterone or matched placebo (randomly assigned 1 : 1) plus abiraterone. Analyses carried out at this ad hoc data cut-off, including the alpha-controlled key secondary endpoint of OS as well as the primary endpoint of investigator-assessed rPFS, were descriptive and not prespecified in the protocol. Results: A total of 1012 patients received capivasertib plus abiraterone (n = 507) or placebo plus abiraterone (n = 505). At this ad hoc analysis at 42% OS maturity (data cut-off: 9 March 2026), with 17 months’ additional follow-up (median follow-up 39 months in both arms), HR for OS favored capivasertib plus abiraterone versus placebo plus abiraterone (HR 0.82, 95% CI 0.68-0.99, P = 0.044) and OS medians were reached: 57.4 versus 46.5 months. Updated rPFS (HR 0.83, 95% CI 0.70-0.99, nominal P = 0.033; median 35.5 versus 26.0 months) was consistent with the primary analysis. The safety profile remained consistent with the primary findings. Conclusions: With longer follow-up, findings from this updated descriptive analysis support the clinically meaningful OS benefit of adding capivasertib to abiraterone in the treatment of patients with PTEN-deficient mHSPC. Capivasertib plus abiraterone represents a first-in-class targeted treatment approach for this poor prognosis population with high unmet need.