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FDA Approval of Capivasertib with Abiraterone and Prednisone in PTEN-Deficient Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer: Expert Panel Discussion

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27 MIN VIDEO
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Conference Highlights Written by Physician Scientists
Presented by Elena Castro, MD, MS, PhD
Dr. Elena Castro discussed CAPItello-281, a phase III trial of capivasertib + abiraterone versus placebo + abiraterone in PTEN-deficient patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC), focusing on the poor prognosis for PTEN-deficient mHSPC patients and abiraterone as a potential treatment.
Presented by Karim Fizazi, MD, PhDKarim Fizazi, MD, PhD
The 2025 European Society for Medical Oncology (ESMO) Annual Congress was host to a prostate, penile, and testicular cancers proffered paper session. Dr. Karim Fizazi presented CAPItello-281, a phase III trial of capivasertib + abiraterone versus placebo + abiraterone in PTEN-deficient patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Dana E. Rathkopf, MD
Dr. Dana Rathkopf presented the results of a real-world analysis of patient characteristics, treatment patterns, and overall survival in metastatic hormone-sensitive prostate cancer (mHSPC) by phosphatase and tensin homologue (PTEN) mutational status, which showed worse outcomes for patients with these alterations.
Publications
Articles and Abstracts

In metastatic hormone-sensitive prostate cancer (mHSPC), PTEN deficiency results in PI3K/AKT pathway activation, providing an independent proliferative drive, which cannot be suppressed by androgen receptor pathway inhibitors (ARPIs), resulting in worse outcomes.

Press Releases
Official Announcements on Clinical Developments
Based on results of CAPItello-281 which prospectively defined PTEN-deficient disease and showed Truqap combination reduced risk of radiographic disease progression or death by 19%
First-in-class AKT inhibitor moves into second tumour type to address an aggressive form of prostate cancer associated with poor prognosis
Reno, Nevada (UroToday.com) -- The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognized a favorable benefit risk profile for AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining.
First and only AKT inhibitor combination to demonstrate benefit in this specific subtype of prostate cancer

Reno, Nevada (UroToday.com) -- Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).