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    TEST:
    MSK-IMPACT

    Company:
    Memorial Sloan-Kettering Cancer Center
    Type:
    FDA Authorized (EUA/De Novo)
    Related tests:
    2d
    A Study of Mirdametinib in People With Central Nervous System Tumors (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial
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    NF1 (Neurofibromin 1)
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    MSK-IMPACT
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    Gomekli (mirdametinib)
    6d
    A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1 trial • Pan tumor
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MTAP (Methylthioadenosine Phosphorylase)
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    HER-2 overexpression • MTAP deletion
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    MSK-IMPACT • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody • PD-L1 IHC 73-10 pharmDx
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • gemcitabine • 5-fluorouracil • oxaliplatin • leucovorin calcium • navlimetostat (BMS-986504)
    10d
    Tumor mutation burden predicts aggressiveness and prognosis of gastrointestinal stromal tumor. (PubMed, Transl Cancer Res)
    TMB appears significantly associated with aggressive clinicopathological features in GIST and serves as an independent prognostic marker. These findings suggest that TMB may hold potential for stratifying GIST patients who may require closer follow-up and more frequent surveillance.
    Journal • Tumor mutational burden • IO biomarker
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    TMB (Tumor Mutational Burden)
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    TMB-H
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    MSK-IMPACT
    20d
    Clinical and genomic profiling of early-onset bladder cancer identifies key alterations and therapeutic targets. (PubMed, medRxiv)
    Our results indicate that early-onset bladder cancer is a distinct patient population that has disease driven by specific somatic mutations, some of which represent therapeutic targets. This suggests potential benefits of genomic tumor profiling in guiding personalized treatment.
    Journal
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    FGFR3 (Fibroblast growth factor receptor 3) • KMT2D (Lysine Methyltransferase 2D)
    |
    FGFR3 mutation
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    MSK-IMPACT
    28d
    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
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • TERT (Telomerase Reverse Transcriptase)
    |
    TP53 mutation
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    MSK-IMPACT
    28d
    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)
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    ER positive
    |
    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, Recruiting, PMV Pharmaceuticals, Inc | Not yet recruiting --> Recruiting
    Enrollment open
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    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 Y220C
    |
    FoundationOne® CDx • MSK-IMPACT • MSK-ACCESS
    |
    metformin • rezatapopt (PC14586) • midazolam hydrochloride
    2ms
    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
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    FGFR3 (Fibroblast growth factor receptor 3) • ERCC2 (Excision repair cross-complementation group 2) • KDM6A (Lysine Demethylase 6A) • STAG2 (Stromal Antigen 2)
    |
    MSK-IMPACT
    2ms
    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
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    HER-2 (Human epidermal growth factor receptor 2) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 amplification
    |
    MSK-IMPACT
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    Kadcyla (ado-trastuzumab emtansine)
    2ms
    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
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    MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • POLD1 (DNA Polymerase Delta 1)
    |
    MSK-IMPACT
    |
    Keytruda (pembrolizumab)
    2ms
    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
    2ms
    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
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    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)
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    MSK-IMPACT
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    Keytruda (pembrolizumab) • Lynparza (olaparib)