Molecular Profile Detail

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Profile Name PALB2 inact mut
Gene Variant Detail

PALB2 inact mut (loss of function)

Relevant Treatment Approaches PARP Inhibitor (Pan)

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
PALB2 inact mut pancreatic ductal adenocarcinoma predicted - sensitive PARP Inhibitor (Pan) Cisplatin + Gemcitabine + Veliparib Phase II Actionable In a Phase II trial, patients with pancreatic ductal adenocarcinoma harboring either a germline BRCA1, BRCA2, or PALB2 inactivating mutation demonstrated a response rate of 65.2% (15/23), a median progression-free survival of 9.7 months, a median overall survival of 16.4 months, and a disease control rate of 78.3% (18/23) when treated with a combination of Gemzar (gemcitabine), Platinol (cisplatin), and Veliparib (ABT-888) (PMID: 31976786). 31976786
PALB2 inact mut prostate cancer predicted - sensitive PARP Inhibitor (Pan) Rucaparib Case Reports/Case Series Actionable In a Phase II trial (TRITON2), 2 of 2 patients with deleterious PALB2 alterations demonstrated a PSA response after treatment with Rubraca (rucaparib), with one of those patients demonstrating partial radiographic response that was ongoing 3.9 months, and the other a 47% reduction in tumor volume (PMID: 32086346; NCT02952534). 32086346
PALB2 inact mut Advanced Solid Tumor sensitive PARP Inhibitor (Pan) Olaparib Preclinical Actionable In a preclinical study, Lynparza (olaparib) resulted in decreased cell survival in a PALB2 deficient cell line derived from a Fanconi anemia patient (PMID: 20871615). 20871615
PALB2 inact mut prostate cancer sensitive PARP Inhibitor (Pan) 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
PALB2 inact mut prostate cancer sensitive PARP Inhibitor (Pan) Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring PALB2 mutations (PMID: 32343890; NCT02987543). detail... detail... 32343890
PALB2 inact mut prostate cancer sensitive PARP Inhibitor (Pan) 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...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04826341 Phase Ib/II Berzosertib + Sacituzumab govitecan-hziy A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors Not yet recruiting
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting
NCT03375307 Phase II Olaparib Olaparib in Treating Patients With Metastatic or Advanced Urothelial Cancer With DNA-Repair Defects Recruiting
NCT04253262 Phase Ib/II Copanlisib + Rucaparib A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Recruiting
NCT04266912 Phase Ib/II Avelumab + Berzosertib Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors Recruiting
NCT04053322 Phase II Durvalumab + Fulvestrant + Olaparib Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) Recruiting
NCT04336943 Phase II Durvalumab + Olaparib Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load Recruiting
NCT04890613 Phase I CX-5461 Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation Not yet recruiting
NCT04171700 Phase II Rucaparib A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) Recruiting
NCT04858334 Phase II Olaparib A Randomized Study of Olaparib or Placebo in Patients With Surgically Removed Pancreatic Cancer Who Have a BRCA1, BRCA2 or PALB2 Mutation, The APOLLO Trial Recruiting
NCT03442556 Phase II Carboplatin + Docetaxel + Rucaparib Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency Recruiting
NCT04493060 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab for Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer Recruiting
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting
NCT02734004 Phase Ib/II Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) Active, not recruiting
NCT04666740 Phase II Olaparib + Pembrolizumab A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy Recruiting
NCT04276376 Phase II Atezolizumab + Rucaparib Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors (ARIANES) Recruiting
NCT02401347 Phase II Talazoparib Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors Recruiting
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting
NCT03840967 Phase II Niraparib A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma Recruiting
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Terminated
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies Recruiting
NCT04693468 Phase I Axitinib + Talazoparib Crizotinib + Talazoparib Palbociclib + Talazoparib Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial Recruiting
NCT03992131 Phase Ib/II Lucitanib + Rucaparib Rucaparib + Sacituzumab govitecan-hziy A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) Active, not recruiting
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Recruiting
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting
NCT04019327 Phase Ib/II Talazoparib + Temozolomide A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer Recruiting
NCT03140670 Phase II Rucaparib Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Active, not recruiting
NCT04756765 Phase II Talazoparib Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Not yet recruiting