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    TEST:
    MSK-IMPACT

    Company:
    Memorial Sloan-Kettering Cancer Center
    Type:
    FDA Authorized (EUA/De Novo)
    Related tests:
    1d
    Effect of co-occurring mutations in TP53 gene and TERT promoter on the survival of bladder cancer patients. (PubMed, Front Immunol)
    Bladder urothelial cancer can be stratified into biologically and clinically distinct subtypes on the basis of cancer driver mutations, with concomitant TERTp/TP53 nucleotide changes strongly linked to reduced patients' overall survival. These results suggest a potential cooperative interaction between mutant TERTp and TP53 in the pathogenesis of bladder cancer, highlighting their significance as prognostic biomarkers and promising targets for novel therapeutic strategies.
    Retrospective data • Journal • Tumor mutational burden
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • TERT (Telomerase Reverse Transcriptase)
    |
    TP53 mutation
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    MSK-IMPACT
    1d
    Rb expression in metastatic ER-positive breast cancer: implications for precision oncology. (PubMed, Breast Cancer Res Treat)
    Rb loss in mBC can be reliably detected by Rb IHC, especially when interpreted alongside p16, offering a rapid and cost-effective means of assessing Rb status. This approach may identify Rb-deficient tumors that are missed by conventional methods, such as next-generation sequencing, and help guide personalized therapeutic strategies in patients with mBC.
    Retrospective data • Journal
    |
    ER (Estrogen receptor) • RB1 (RB Transcriptional Corepressor 1)
    |
    ER positive
    |
    MSK-IMPACT
    14d
    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, Recruiting, PMV Pharmaceuticals, Inc | Not yet recruiting --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 Y220C
    |
    FoundationOne® CDx • MSK-IMPACT • MSK-ACCESS
    |
    metformin • rezatapopt (PC14586) • midazolam hydrochloride
    18d
    Comparative genomic landscape of primary and metastatic bladder urothelial carcinoma in a large-scale cohort. (PubMed, Int J Clin Oncol)
    Primary and metastatic lesions of bladder urothelial carcinoma show broadly similar gene- and pathway-level alteration profiles on targeted DNA sequencing. TP53 pathway and apoptosis-related alterations are modestly more frequent in metastases, consistent with impaired stress responses and apoptosis evasion.
    Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3) • ERCC2 (Excision repair cross-complementation group 2) • KDM6A (Lysine Demethylase 6A) • STAG2 (Stromal Antigen 2)
    |
    MSK-IMPACT
    22d
    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)
    23d
    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)
    28d
    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
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    KRAS (KRAS proto-oncogene GTPase) • GATA3 (GATA binding protein 3)
    |
    KRAS mutation
    |
    MSK-IMPACT
    1m
    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)
    2ms
    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
    2ms
    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
    2ms
    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
    2ms
    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