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    TEST:
    MSK-IMPACT

    Company:
    Memorial Sloan-Kettering Cancer Center
    Type:
    FDA Authorized (EUA/De Novo)
    Related tests:
    3d
    Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers (clinicaltrials.gov)
    P2, N=131, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 amplification
    |
    MSK-IMPACT
    |
    Kadcyla (ado-trastuzumab emtansine)
    3d
    Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype (clinicaltrials.gov)
    P=N/A, N=27, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • POLD1 (DNA Polymerase Delta 1)
    |
    MSK-IMPACT
    |
    Keytruda (pembrolizumab)
    8d
    Consensus Copy-Number Alteration Signatures from Clinical Panels Enable Pan-Cancer Risk Stratification and Therapy Response Association. (PubMed, Int J Mol Sci)
    Associations with driver mutations (GATA3 in CON1, KRAS in CON5) supported biological specificity, and the signatures delineated resistance landscapes for chemotherapy, hormonal, targeted, and immunotherapy. By converting routine panel data into biologically interpretable prognostic features, our framework enables risk stratification and therapeutic guidance in precision oncology.
    Journal • IO biomarker • Pan tumor
    |
    KRAS (KRAS proto-oncogene GTPase) • GATA3 (GATA binding protein 3)
    |
    KRAS mutation
    |
    MSK-IMPACT
    16d
    SPORE: 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 (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • BAP1 (BRCA1 Associated Protein 1) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD50 (RAD50 Double Strand Break Repair Protein) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • FANCC (FA Complementation Group C)
    |
    MSK-IMPACT
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    1m
    A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer (clinicaltrials.gov)
    P1, N=28, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    MSK-IMPACT
    |
    carboplatin • paclitaxel
    1m
    AlphaMissense pathogenicity scores predict response to immunotherapy and enhances the predictive capability of tumor mutation burden. (PubMed, Transl Oncol)
    AlphaTMB improves survival prediction beyond TMB alone, better captures immunogenic tumor profiles, and reflects more accurate patient stratification. This AI derived somatic mutations pathogenicity scoring represents a step toward personalized immuno-oncology and merits further validation in prospective studies.
    Journal • Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden) • POLE (DNA Polymerase Epsilon)
    |
    TMB-H • POLE mutation • TMB-L
    |
    MSK-IMPACT
    1m
    Extreme Tumor Mutational Burden Predicts Near-Curative Outcomes With Checkpoint Immunotherapy in Melanoma: Half the Eligible, Half the Cure. (PubMed, Pigment Cell Melanoma Res)
    A super-high TMB threshold of ≥ 25 mut/Mb by MSK-IMPACT identifies a distinct subset of melanoma patients who achieve truly exceptional benefit, with nearly one in two attaining clinical cure following ICB therapy. These data support prospective validation of "hypermutation" as a clinically actionable biomarker, refine patient counseling, and inform trial stratification in the era of personalized cancer immunotherapy.
    Journal • Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    MSK-IMPACT
    1m
    Chromosome 1p13.2 gene cluster upregulation in neuroblastoma RAS viral oncogene homolog pathogenic variant melanoma: a potential biomarker axis. (PubMed, Melanoma Res)
    NRAS-mutant melanomas harbor a coordinated transcriptional program within 1p13.2, driven by CNV gains. This locus contains genes with potential druggability, offering new avenues for combinatorial targeting alongside mitogen-activated protein kinase pathway inhibition.
    Journal
    |
    BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • TRIM33 (Tripartite Motif Containing 33)
    |
    BRAF mutation • NRAS mutation
    |
    MSK-IMPACT
    1m
    A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, PMV Pharmaceuticals, Inc
    New P1 trial
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 Y220C
    |
    FoundationOne® CDx • MSK-IMPACT • MSK-ACCESS
    |
    metformin • rezatapopt (PC14586) • midazolam hydrochloride
    1m
    A Study of Revumenib and Mezigdomide in People With Leukemia (clinicaltrials.gov)
    P1/2, N=52, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2)
    |
    MSK-IMPACT
    |
    Revuforj (revumenib) • mezigdomide (CC-92480)
    2ms
    Distribution and prognostic impact of LymphGen subtypes in Korean diffuse large B-cell lymphoma using clinical NGS panel. (PubMed, Blood Adv)
    Kaplan-Meier analysis of R-CHOP-treated patients with DLBCL-NOS revealed that those with MCD, BN2, and A53 subtypes had poorer overall survival than those with EZB and ST2, particularly among patients with concurrent MYC/BCL2 DE. Using a clinically applicable NGS panel, we successfully implemented the LymphGen classification system. This study underscores the distinct genetic landscape of Korean DLBCL and highlights the utility of LymphGen in identifying high-risk subgroups, providing a basis for prognostic stratification and therapeutic optimization.
    Journal • Next-generation sequencing • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    MSK-IMPACT
    |
    Rituxan (rituximab)
    2ms
    RRAS and RRAS2 mutations are recurrent oncogenic drivers in lung cancer and are sensitive to the pan-RAS inhibitor RMC-6236. (PubMed, Clin Cancer Res)
    RRASQ87L and RRAS2Q72L are recurrent, oncogenic, and potentially actionable drivers in NSCLC. Our study supports the inclusion of RRAS/RRAS2 into routine molecular diagnostic panels for precision oncology and provides preclinical rationale for investigating the potential therapeutic utility of pan-RAS inhibitors for patients with RRASQ87L/RRAS2Q72L-mutant lung cancers.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    NRAS Q61 • KRAS Q61
    |
    MSK-IMPACT
    |
    daraxonrasib (RMC-6236)