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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 estrogen-receptor positive breast cancer sensitive PARP Inhibitor (Pan) Talazoparib Guideline Actionable Talzenna (talazoparib) is included in guidelines as second-line therapy for patients with ESR1 (ER)-positive, ERBB2 (HER2)-negative metastatic breast cancer with germline or somatic pathogenic/likely pathogenic PALB2 mutations who have progressed on an endocrine therapy plus CDK4/6 inhibitor (PMID: 34678411; ESMO.org). 34678411 detail...
PALB2 inact mut breast cancer predicted - sensitive PARP Inhibitor (Pan) Olaparib Phase II Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment resulted in an objective response rate (ORR) of 33% (9/27) and a clinical benefit rate (CBR) at 18 weeks of 50% in patients with metastatic breast cancer harboring germline mutations in homologous recombination-related genes other than BRCA1/2, all responders harbored germline PALB2 inactivating mutations, ORR and CBR in PALB2-mutant patients (n=11) were 82% and 100%, respectively (PMID: 33119476; NCT03344965). 33119476
PALB2 inact mut estrogen-receptor positive breast cancer sensitive PARP Inhibitor (Pan) Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy for patients with ESR1 (ER)-positive, ERBB2 (HER2)-negative metastatic breast cancer with germline or somatic pathogenic/likely pathogenic PALB2 mutations who have progressed on an endocrine therapy plus CDK4/6 inhibitor (PMID: 34678411; ESMO.org). detail... 34678411
PALB2 inact mut prostate cancer predicted - sensitive PARP Inhibitor (Pan) Abiraterone + Niraparib + Prednisone Phase III Actionable In a Phase III trial (MAGNITUDE), Zejula (niraparib) in combination with Zytiga (abiraterone) and Adasone (prednisone) (AAP) significantly improved radiographic progression-free survival (16.5 vs 13.7 mo, HR 0.73, p=0.0217) compared to placebo and AAP in patients with metastatic castration-resistant prostate cancer harboring alterations in homologous recombination repair genes including ATM, BRCA1/2, BRIP1, CHEK2, FANCA, HDAC2, and PALB2 (J Clin Oncol 40, 2022 (suppl 6; abstr 12); NCT03748641). detail...
PALB2 inact mut pancreatic ductal adenocarcinoma no benefit PARP Inhibitor (Pan) Cisplatin + Gemcitabine + Veliparib Phase II Actionable In a Phase II trial, the addition of Veliparib (ABT-888) to Gemzar (gemcitabine) and Platinol (cisplatin) in pancreatic ductal adenocarcinoma patients with either a germline BRCA1, BRCA2, or PALB2 inactivating mutation did not improve response rate (RR) compared to Gemzar (gemcitabine) and Platinol (cisplatin) alone, with 74.1% (20/27) vs 65.2% (15/23), P=0.55, and led to similar median progression-free survival, 10.1 vs 9.7 mo, P=0.73, and median overall survival, 15.5 vs 16.4 mo, P=0.6 (PMID: 31976786). 31976786
PALB2 inact mut pancreatic ductal adenocarcinoma sensitive Cisplatin + Gemcitabine 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) and Platinol (cisplatin) (PMID: 31976786). 31976786
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...
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 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 Her2-receptor negative breast cancer predicted - sensitive PARP Inhibitor (Pan) Talazoparib Case Reports/Case Series Actionable In a Phase II trial, Talzenna (talazoparib) treatment was well tolerated, and among 12 evaluable ERBB2 (HER2)-negative breast cancer patients with a homologous repair pathway mutation resulted in response in 25% (3/12) of patients, including two patients with germline mutations in PALB2, and resulted in stable disease for >/= 6 months in 3 patients, including one patient with a germline PALB2 mutation (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 3006). detail...
PALB2 inact mut pancreatic cancer predicted - sensitive PARP Inhibitor (Pan) Rucaparib Phase II Actionable In a Phase II trial, maintenance Rubraca (rucaparib) resulted in a median progression-free survival (mPFS) of 13.1 months and an objective response rate (ORR) of 41.7% (15/36, 3 complete responses, 12 partial responses) in patients with platinum-sensitive, advanced pancreatic cancer harboring deleterious mutations in BRCA1/2 or PALB2, ORR was 50% (3/6) in patients with PALB2 mutations (PMID: 33970687; NCT03140670). 33970687
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
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 USA 0
NCT04983745 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) Not yet recruiting USA 0
NCT05417594 Phase Ib/II AZD9574 AZD9574 + Temozolomide Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1) Not yet recruiting USA | ESP | DEU 4
NCT04756765 Phase II Talazoparib Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Not yet recruiting USA 0
NCT04985721 Phase II Pamiparib + Tislelizumab A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects (IMPARP-HRD) Recruiting 1
NCT04053322 Phase II Durvalumab + Fulvestrant + Olaparib Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) Recruiting FRA 0
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) Completed USA | FRA 5
NCT05010096 Phase I BAY1895344 + Copanlisib BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Withdrawn 0
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Active, not recruiting USA 0
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting USA 0
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 USA 0
NCT05169437 Phase II Niraparib Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors Recruiting USA 0
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 USA 0
NCT05071209 Phase Ib/II BAY1895344 Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors Recruiting USA 0
NCT05174455 Phase II Niraparib Niraparib for the Treatment of Leiomyosarcoma Not yet recruiting USA 0
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Terminated USA 0
NCT05340413 Phase II Olaparib Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) Recruiting ESP 0
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies Recruiting USA 0
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 USA 0
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Completed USA | CAN 0
NCT04171700 Phase II Rucaparib A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) Active, not recruiting USA 0
NCT04493060 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab for Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer Recruiting USA 0
NCT04019327 Phase Ib/II Talazoparib + Temozolomide A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer Recruiting USA 0
NCT04890613 Phase I CX-5461 Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation Recruiting USA | CAN 0
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 FRA 0
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 USA 0
NCT05379972 Phase II Olaparib + Pembrolizumab Phase II Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers Not yet recruiting USA 0
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting USA 0
NCT04266912 Phase Ib/II Avelumab + Berzosertib Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors Recruiting USA 0
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting USA 0
NCT05188508 Phase II Olaparib + Pembrolizumab + Temozolomide Pembrolizumab, Olaparib, and Temozolomide for People With Glioma Recruiting USA 0
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 Recruiting USA 0
NCT04253262 Phase Ib/II Copanlisib + Rucaparib A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Recruiting USA 0
NCT04336943 Phase II Durvalumab + Olaparib Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load Recruiting USA 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting USA 0
NCT05033756 Phase II Olaparib + Pembrolizumab Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO (COMPRENDO) Not yet recruiting DEU 0
NCT03344965 Phase II Olaparib Olaparib In Metastatic Breast Cancer Recruiting USA 0
NCT05038839 Phase I Cabozantinib + Pamiparib Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors Recruiting USA 0
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 USA 0
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 USA 0
NCT02401347 Phase II Talazoparib Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors Recruiting USA 0