Real-World Data Confirm Safety and Efficacy of Novartis' Votrient (Pazopanib) in Patients with Metastatic Renal Cell Carcinoma

News on February 20, 2022 /BioValleyBIOON/ -- According to recent reports at the 2022 American ClinicalTumorResults from a study presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU),Real-World Data (RWD) ConfirmsNovartisVotrient (pazopanib) is safe and effective for patients with metastatic renal cell carcinoma (RCC).

Votrient is a tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptor (VEGFR), which works by inhibitingTumorActs by generating new blood vessels that supply blood. The drug was approved for marketing in the United States and the European Union in October 2009 and June 2010, respectively. Votrient originally belonged toGSK(GSK) product, but in 2014, GSK andNovartisIn the asset swap transaction, it was packaged and sold.

Votrient has been proven to be a highly effective first-line treatment for renal cell carcinoma (RCC) and has now been approved in many countries around the world.In China, Votrient was approved in 2017 for the first-line treatment of patients with advanced RCC and for the treatment of patients with advanced RCC who have previously received cytokine therapy.

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

Eligible mRCC patients (N=217) were included in the 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% of patients were low-risk IMDC, 52.1% were intermediate-risk, and 20.8% were high-risk. EasternTumorThe 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%).

According to the interim research results (30 months after enrollment),Patients treated with Votrient had a median PFS of 10.5 months (95% CI: 9-12.4).: The median PFS for patients under 65 years old was 11.3 months (95% CI: 7-16.3), and the median PFS for patients aged 65 years or older was 9.9 months (95% CI: 8.9-12). According to the IMDC risk score assessment, the median PFS in low, intermediate, and high-risk mRCC patients were 18.1 months (95% CI: 9.9-23.3), 11.5 months (95% CI: 8.7-14.4), and 6.2 months (95% CI: 3.5-9.5), respectively.

The research results also showed that,mRCC patients treated with Votrient had a median OS of 27.3 months.（95%CI:24.3-ND）。The ORR assessed by the researchers was 48.3%.Among them, 6 patients achieved complete remission (CR, 3.5%), and 77 patients achieved partial remission (PR, 44.8%).

In the study, no new safety events of Votrient were found. Dose reductions and discontinuations due to adverse events occurred in 42% and 40.9% of patients, respectively. Serious adverse events related to treatment were reported in 22.2% of patients.

When assessing the impact of COVID-19, it was found that the pandemic had a limited effect on patient care. Patient visits and teleconsultations were used.TumorEvaluation and Follow-up. During the pandemic, only 5.7% of patients did not visit.

Based on the above results, the researchers concluded that:Votrient is safe and effective for mRCC patients in real-world settings. Moreover, the efficacy of Votrient remains significant in patients aged 65 and above and is highly correlated with risk scores.(Bioon.com)