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    Home > Biochemistry News > Biotechnology News > Novartis Votrient safe and effective for patients with metastatic renal cell carcinoma!

    Novartis Votrient safe and effective for patients with metastatic renal cell carcinoma!

    • Last Update: 2022-05-24
    • Source: Internet
    • Author: User
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    Real-world data (RWD) confirm Novartis' anticancer drug Votrient ) is safe and effective in patients with metastatic renal cell carcinoma (RCC)
    .

    Votrient is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) that works by inhibiting the formation of new blood vessels that supply blood to tumors
    .
    The drug was approved for marketing in the United States and the European Union in October 2009 and June 2010, respectively

    .
    Votrient was originally a product of GlaxoSmithKline (GSK), but in 2014 it was packaged and sold in an asset swap transaction between GSK and Novartis

    .

    Votrient has been shown to be a potent first-line treatment for renal cell carcinoma (RCC) and is currently approved in several countries around the world
    .
    In China, Votrient was approved in 2017 for the first-line treatment of patients with advanced RCC, as well as for the treatment of patients with advanced RCC cancer who have received cytokine therapy

    .

    To further evaluate the efficacy and safety of Votrient in real-world clinical practice, we conducted a non-interventional multicenter study (APOLON) in patients receiving first-line Votrient therapy, evaluating progression-free survival (PFS), overall Survival (OS), investigator-assessed objective response rate (ORR), and tolerability
    .
    In addition, the impact of COVID-19 on patient care was also assessed

    .

    Eligible mRCC patients (N=217) were included for evaluation, with a median age of 69.
    6 years

    .
    Patients were stratified according to the IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) risk score; 27.
    1% were IMDC low risk, 52.
    1% intermediate risk, and 20.
    8% high risk

    .
    The proportions of patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 0, 1, and ≥2 were 43.
    3%, 39%, and 17.
    6%, respectively

    .
    Metastases mainly occurred in the lungs (64.
    1%), bones (28.
    6%), mediastinum (18%), and abdomen (17.
    1%)

    .

    Median PFS was 10.
    5 months (95% CI: 9-12.
    4) for patients treated with Votrient, according to interim study results (30 months after enrollment): among them, median PFS was 11.
    3 months for patients under 65 years of age (95%CI: 7-16.
    3), the median PFS in patients 65 years and older was 9.
    9 months (95%CI: 8.
    9-12)

    .
    The median PFS was 18.
    1 months (95%CI: 9.
    9-23.
    3), 11.
    5 months (95%CI: 8.
    7-14.
    4), 6.
    2 months in mRCC low, intermediate, and high risk patients, respectively, as assessed by the IMDC risk score month (95%CI: 3.
    5-9.
    5)

    .

    The results also showed that the median OS of mRCC patients treated with Votrient was 27.
    3 months (95%CI: 24.
    3-ND)

    .
    The investigator-assessed ORR was 48.
    3%, with 6 patients achieving a complete response (CR, 3.
    5%) and 77 patients achieving a partial response (PR, 44.
    8%)

    .

    During the study, no new security incidents for Votrient were identified
    .
    Dose reductions and discontinuations due to adverse events occurred in 42% and 40.
    9% of patients, respectively

    .
    Treatment-related serious adverse events were reported in 22.
    2% of patients

    .

    When assessing the impact of COVID-19, the pandemic was found to have limited impact on patient care
    .
    Patient visits and teleconsultations were used for tumor assessment and follow-up

    .
    During the pandemic, only 5.
    7% of patients did not seek medical care

    .

    Based on the above results, the researchers concluded that Votrient is safe and effective in mRCC patients in a real-world setting
    .
    In addition, the efficacy of Votrient in patients 65 years and older remained significant and was highly correlated with risk scores

    .

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