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Association details:
| Biomarker: | PTEN deletion |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | ipatasertib (RG7440) (PI3K inhibitor, AKT inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study
Published date:
10/28/2022
Excerpt:
...improved survival was found in patients with PTEN-loss tumors...The exposure-efficacy results indicated that patients receiving ipatasertib may continue benefiting from this treatment at the administered dose…
DOI:
10.1007/s00280-022-04488-2
Trial ID:
Source:
Title:
Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial
Published date:
07/10/2021
Excerpt:
In the 521 (47%) patients who had tumours with PTEN loss by immunohistochemistry (261 in the placebo-abiraterone group and 260 in the ipatasertib-abiraterone group), median radiographical progression-free survival was 16·5 months (95% CI 13·9-17·0) in the placebo-abiraterone group and 18·5 months (16·3-22·1) in the ipatasertib-abiraterone group (hazard ratio [HR] 0·77 [95% CI 0·61-0·98]; p=0·034; significant at α=0·04).
Secondary therapy:
abiraterone acetate
DOI:
10.1016/S0140-6736(21)00580-8
Source:
Title:
IPATential150: Phase III study of ipatasertib (ipat) plus abiraterone (abi) vs placebo (pbo) plus abi in metastatic castration-resistant prostate cancer (mCRPC)
Published date:
09/19/2020
Excerpt:
...In PTEN loss by IHC pts, median rPFS was 18.5 mo (95% CI: 16.3, 22.1) with ipat and 16.5 mo (95% CI: 13.9, 17.0) with pbo (HR: 0.77; 95% CI: 0.61, 0.98; P = 0.0335)....In this primary endpoint analysis, ipat + abi as first-line treatment for mCRPC resulted in significantly improved rPFS and antitumor activity vs pbo + abi in pts with PTEN-loss mCRPC, but not in the ITT.
Secondary therapy:
abiraterone acetate + prednisone
Trial ID:
Source:
Title:
Phase III IPATential150 Study Evaluating Ipatasertib in Combination with Abiraterone and Prednisone/Prednisolone in Patients with Metastatic Castration-Resistant Prostate Cancer Meets One of Its Co-Primary Endpoint
Published date:
06/19/2020
Excerpt:
...the phase III IPATential 150 study, evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone as an initial treatment for metastatic castration-resistant prostate cancer (mCRPC) met one of its co-primary endpoints of radiographic progression-free survival (rPFS) in patients whose tumor had PTEN loss.
Secondary therapy:
abiraterone acetate + prednisone; prednisone
Trial ID:
