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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.


    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.

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


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

    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.


    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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