^
    3ms
    Immune and Growth Factor Signaling Pathways Are Associated with Pathologic Complete Response to an Anti-Type I Insulin-like Growth Factor Receptor Regimen in Patients with Breast Cancer. (PubMed, Clin Cancer Res)
    Pretreatment specimens from patients treated on the I-SPY2 neoadjuvant breast cancer trial were studied to identify prespecified biomarkers associated with response to the regimen of paclitaxel, the anti-type I insulin-like growth factor receptor (IGF-1R) antibody ganitumab, and metformin (PGM) followed by doxorubicin and cyclophosphamide (AC) compared with control therapy (paclitaxel followed by AC). Immune activation markers were also associated with response in HR+ and HR- subgroups. Thus, IGF-1R may directly regulate tumor biology and associate with immune response to therapy.
    Journal
    |
    STAT1 (Signal Transducer And Activator Of Transcription 1)
    |
    HR positive
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • ganitumab (AMG 479) • metformin
    5ms
    Systematic screening of metabolic pathways to identify two breast cancer subtypes with divergent immune characteristics. (PubMed, Sci Rep)
    Drug sensitivity analysis revealed that BCMS-II was highly sensitive to Ganitumab, Carboplatin + ABT-888, and Pembrolizumab. Our findings highlight the heterogeneity of BRCA in terms of metabolic features, immune characteristics, clinical prognosis, and drug sensitivity. The novel classification system provides valuable insights for clinical diagnosis and treatment, serving as a foundation for precision diagnosis and personalized therapies in BRCA.
    Journal
    |
    BRCA (Breast cancer early onset)
    |
    Keytruda (pembrolizumab) • carboplatin • veliparib (ABT-888) • ganitumab (AMG 479)
    6ms
    Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1 --> P=N/A
    Phase classification
    |
    everolimus • temozolomide • doxorubicin hydrochloride • pazopanib • cyclophosphamide • ifosfamide • irinotecan • Torisel (temsirolimus) • vincristine • daunorubicin • ganitumab (AMG 479)
    1year
    AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov)
    P3, N=312, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • vincristine • daunorubicin • ganitumab (AMG 479)
    1year
    QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=138, Completed, NantCell, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    gemcitabine • ganitumab (AMG 479) • conatumumab (AMG 655)
    1year
    Targeting IGF-IR improves neoadjuvant chemotherapy efficacy in breast cancers with low IGFBP7 expression. (PubMed, NPJ Precis Oncol)
    We report that low IGFBP7 gene expression identifies a subset of breast cancers for which the addition of ganitumab, an anti-IGF-1R monoclonal antibody, to neoadjuvant chemotherapy, substantially improved the pathological complete response rate compared to neoadjuvant chemotherapy alone...Furthermore, high IGFBP7 expression predicted increased distant metastasis risk. If our findings are confirmed, decisions to halt the development of IGF-1R targeting drugs, which were based on disappointing results of prior trials that did not use predictive biomarkers, should be reviewed.
    Journal
    |
    IGFBP7 (Insulin Like Growth Factor Binding Protein 7)
    |
    IGFBP7 overexpression
    |
    ganitumab (AMG 479)
    1year
    QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=15, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2 | N=49 --> 15
    Phase classification • Enrollment change • Combination therapy • Metastases
    |
    carboplatin • paclitaxel • ganitumab (AMG 479)
    over1year
    QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=213, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Subjects discontinued study
    Phase classification • Trial termination • Combination therapy
    |
    cisplatin • carboplatin • etoposide IV • ganitumab (AMG 479) • rilotumumab (AMG 102)
    over1year
    QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=89, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    ganitumab (AMG 479) • conatumumab (AMG 655)
    over1year
    Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P1/2, N=177, Completed, NantBioScience, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Vectibix (panitumumab) • ganitumab (AMG 479) • rilotumumab (AMG 102)
    over1year
    Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov)
    P2, N=10, Terminated, Dana-Farber Cancer Institute | Completed --> Terminated; The study closed early due to discontinuation of ganitumab supply.
    Trial termination
    |
    CDK4 (Cyclin-dependent kinase 4) • EWSR1 (EWS RNA Binding Protein 1) • IGF1 (Insulin-like growth factor 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor) • FUS (FUS RNA Binding Protein)
    |
    Ibrance (palbociclib) • ganitumab (AMG 479)
    over1year
    GAMMA: QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P3, N=800, Completed, NantCell, Inc. | Terminated --> Completed
    Trial completion
    |
    gemcitabine • ganitumab (AMG 479)