Brand: Truqap

Initial US Approval

  • 2023 (breast cancer). Prostate cancer indication approved June 12, 2026.1,2

Indications

PTEN-Deficient mAPMN/S Prostate Cancer:

  • In combination with abiraterone and prednisone for adult patients with metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.1
  • Patient selection: PTEN deficiency in tumor tissue by the VENTANA PTEN (SP218) RxDx Assay (at least 90% of viable malignant cells with no specific cytoplasmic staining).1,2

Recommended Dose/Route

  • 400 mg orally twice daily (about 12 hours apart), with or without food, 4 days on and 3 days off, until disease progression or unacceptable toxicity.1
  • With abiraterone 1000 mg plus prednisone 5 mg once daily (CAPItello-281 used prednisone or prednisolone). Patients should also receive a GnRH analog concurrently or should have had bilateral orchiectomy.1,2

Dose Reductions for Adverse Reactions

Figure

Pivotal Study

CAPItello-281 (NCT04493853)

  • Key Inclusion Criteria: de novo metastatic hormone-sensitive prostate adenocarcinoma diagnosed within 180 days, PTEN deficiency by central IHC, at least 1 bone or soft-tissue lesion on CT/MRI (PSMA PET-only disease not eligible), ADT started within 93 days, ECOG 0 or 1. Excluded: type 1 diabetes, insulin-requiring type 2 diabetes, or HbA1c 8% or higher.1,4
  • Treatment: 1012 patients randomized 1:1, double blind, to capivasertib plus abiraterone (n=507) or placebo plus abiraterone (n=505), each with prednisone or prednisolone and ADT. High-volume disease 74%.1
Figure
  • Fair balance: the rPFS improvement was modest, the BICR-assessed rPFS analysis was not statistically significant, and OS was immature and not significant at the rPFS analysis (final OS expected around Q4 2027). The ODAC voted 7 to 1, with 1 abstention, for a favorable benefit-risk.1,3,5

Safety

CAPItello-281 (N=503)

  • Summary: serious adverse reactions 47%, fatal 8%, discontinuation 20% (cutaneous 8%), dose reduction 32%, dose interruption 65%.1
  • Key warnings: hyperglycemia (increased fasting glucose 69%, grade 3 12%; diabetic ketoacidosis 1.2%; insulin required in 16%); diarrhea (52%, grade 3 6%); cutaneous adverse reactions (53%, grade 3 17%); embryo-fetal toxicity.1
Figure

References

  1. Truqap (capivasertib) tablets. Prescribing information. AstraZeneca Pharmaceuticals LP; revised 09/2026. Accessed October 2026.
  2. FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naive or -sensitive prostate cancer. US Food and Drug Administration. June 12, 2026.
  3. Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016/j.annonc.2025.10.004
  4. ClinicalTrials.gov. CAPItello-281 (NCT04493853). Accessed October 2026.
  5. US Food and Drug Administration. Oncologic Drugs Advisory Committee meeting, April 30, 2026: capivasertib. Accessed October 2026.