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Molecular Profile PALB2 inact mut
Therapy Olaparib
Indication/Tumor Type prostate cancer
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PALB2 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in PALB2 (NCCN.org). detail...
PALB2 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment improved median progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) vs control in metastatic castration-resistant prostate cancer patients with deleterious/suspected deleterious homologous recombination repair gene mutations who progressed on hormone therapy, including PALB2 nonsense, frameshift, or splice site variants, rearrangement, or copy loss as detected by approved assays (PMID: 32343890; NCT02987543). detail... detail... 32343890
PALB2 inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 57.1% (4/7) and a RECIST objective response rate of 33.3% (2/6) in patients with castration-resistant prostate cancer harboring deleterious PALB2 mutations (PMID: 31806540; NCT01682772). 31806540
PubMed Id Reference Title Details
NCCN.org Full reference...
Full reference...
Lynparza (olaparib) FDA Drug Label Full reference...
(31806540) Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial. Full reference...
(32343890) Olaparib for Metastatic Castration-Resistant Prostate Cancer. Full reference...