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Association details:
Biomarker:ATM mutation
Cancer:Prostate Cancer
Drug:Rubraca (rucaparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Rucaparib or Physician's Choice in Metastatic Prostate Cancer

Published date:
02/23/2023
Excerpt:
In this randomized, controlled, phase 3 trial, we enrolled patients who had metastatic, castration-resistant prostate cancer with a BRCA1, BRCA2, or ATM alteration...In an exploratory analysis in the ATM subgroup, the median duration of imaging-based progression-free survival was 8.1 months in the rucaparib group and 6.8 months in the control group (hazard ratio, 0.95; 95% CI, 0.59 to 1.52).
DOI:
10.1056/NEJMoa2214676
Evidence Level:
Sensitive: B - Late Trials
Title:

TRITON3 Phase 3 Trial of Rubraca® (rucaparib) Achieves Primary Endpoint in Men with Metastatic Castration-Resistant Prostate Cancer with BRCA or ATM Mutations

Published date:
10/03/2022
Excerpt:
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive top-line data from the Phase 3, open-label, multicenter, randomized TRITON3 trial demonstrating that Rubraca monotherapy treatment achieved the primary endpoint of significantly improved radiographic progression-free survival (rPFS)...Benefit was observed in both primary efficacy analyses of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC): first, those who had mutations in BRCA, as well as all patients randomized in the trial, inclusive of mutations in BRCA or ATM (the overall intent-to-treat population (ITT)).
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Excerpt:
...- Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Excerpt:
...- Have a deleterious mutation in a BRCA1/2 or ATM gene...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

Excerpt:
...- Presence of pathogenic or likely pathogenic germline mutation/variant in BRCA2, BRCA1, ATM or PALB2 -...