FDA Approves Truqap plus Abiraterone as First Targeted Therapy for PTEN-Deficient Prostate Cancer
On June 12, 2026, the FDA approved AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone acetate and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (historically referred to as metastatic hormone-sensitive prostate cancer, or mHSPC) that is PTEN-deficient.
Concurrently, the FDA approved the VENTANA PTEN (SP218) RxDx Assay (developed by Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic device to identify patients with PTEN-deficient tumors. PTEN deficiency is defined as ≥90% of viable malignant cells with no specific cytoplasmic staining.
This approval represents the first targeted, biomarker-directed therapy specifically approved for PTEN-deficient metastatic hormone-sensitive prostate cancer.1
Clinical Trial Data: CAPItello-281
The approval was supported by data from the Phase 3 CAPItello-281 (NCT04305496) trial, a randomized, double-blind, placebo-controlled study that enrolled 1,012 adults with newly diagnosed, PTEN-deficient mAPMN/S prostate cancer. Highlights include:
- Efficacy: A statistically significant improvement in investigator-assessed radiographic progression-free survival (rPFS) was demonstrated in the capivasertib + abiraterone arm compared to the placebo + abiraterone arm.
- Median rPFS: 33.2 months (95% CI: 25.8, 44.2) in the capivasertib arm compared to 25.7 months (95% CI: 22.0, 29.9) in the placebo/control arm.
- Hazard Ratio (HR): 0.81 (95% CI: 0.66, 0.98; two-sided p-value = 0.034), indicating a 19% reduction in the risk of radiographic progression or death.
- Overall Survival (OS): OS results were immature at the time of the rPFS analysis.
Administration and Side Effects
The recommended dosage of capivasertib is 400 mg orally twice daily (approximately 12 hours apart) with or without food, taken for four days followed by three days off (an intermittent schedule designed to manage toxicities) until disease progression or unacceptable toxicity. Abiraterone is administered at 1000 mg once daily with prednisone 5 mg once daily.
Key safety warnings and precautions in the Truqap prescribing label include hyperglycemia, severe diarrhea, and cutaneous (skin) adverse reactions.
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An instance of No cancer driver remains permanently undruggable under precise molecular targeting. — Developing precise clinical inhibitors against hyperactivated pathways successfully bypasses genetic resistance driven by PTEN deficiency. ↩︎