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21h
TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
P1/2, N=117, Active, not recruiting, Cantargia AB | Trial primary completion date: Jun 2025 --> Apr 2026
Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
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BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
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PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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carboplatin • gemcitabine • nadunolimab (CAN04)
7d
DIONE-01: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (clinicaltrials.gov)
P1, N=210, Active, not recruiting, iOnctura | Trial completion date: Mar 2025 --> Mar 2027
Trial completion date • First-in-human
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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BRAF mutation • BRAF V600 • ALK translocation
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)
10d
Comprehensive analysis of FGFR2b and its correlation with essential biomarkers, intratumoral heterogeneity, and survival in advanced gastric cancer. (PubMed, Br J Cancer)
FGFR2b positivity was higher in MU GC and in GC samples with shorter storage periods. However, no significant association was observed between FGFR2b expression and other key biomarkers or survival outcomes.
Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • CLDN18 (Claudin 18) • FPR2 (Formyl Peptide Receptor 2)
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PD-L1 IHC 22C3 pharmDx
13d
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma (Agilent Technologies Press Release)
"Agilent Technologies...today announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy." "
Approval
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PD-L1 IHC 22C3 pharmDx
13d
IMPRINTER: A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=24, Terminated, Imugene Limited | Active, not recruiting --> Terminated; Portfolio prioritization
Trial termination
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
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Tecentriq (atezolizumab) • PD1-Vaxx
14d
Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC (clinicaltrials.gov)
P2, N=26, Recruiting, Diwakar Davar | Trial completion date: Dec 2030 --> Dec 2036 | Trial primary completion date: Dec 2030 --> Dec 2036
Trial completion date • Trial primary completion date
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab)
15d
Enrollment closed • Enrollment change
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PD-L1 (Programmed death ligand 1)
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • sunitinib
20d
INBRX106-01-201: Phase 2/3 Randomized Study of INBRX-106 Add-on to Pembrolizumab in First-Line PD-L1 CPS ?20 R/M HNSCC (HexAgon-HN) (2024-515538-34-00)
P2/3, N=175, Active, not recruiting, Inhibrx Biosciences Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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PD-L1 (Programmed death ligand 1)
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • ordastobart (INBRX-106)
23d
Enrollment closed
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PD-L1 (Programmed death ligand 1)
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed • ImmuFact (eftilagimod alpha)
26d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 negative
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PD-L1 IHC 22C3 pharmDx
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Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Hetronifly (serplulimab)
27d
New trial • IO biomarker
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PD-L1 (Programmed death ligand 1)
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PD-L1 IHC 22C3 pharmDx • VENTANA CLDN18 (43-14A) Assay
29d
Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC (clinicaltrials.gov)
P2, N=26, Recruiting, Diwakar Davar | Trial completion date: Dec 2029 --> Dec 2030 | Trial primary completion date: Dec 2029 --> Dec 2030
Trial completion date • Trial primary completion date
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab)