Tony Hagen is senior managing editor for The Center for Biosimilars®.
The study was designed to elucidate incidence of hypertension and proteinuria in patients treated with bevacizumab reference vs biosimilar products.
Results were inconclusive in a study of hypertension and proteinuria in 75 patients treated with bevacizumab reference vs biosimilar products, investigators reported at the ASCO Gastrointestinal Cancers Symposium 2021.
They compared incidence of hypertension and proteinuria in patients treated with various chemotherapy regimens in combination with bevacizumab. Investigators evaluated reference bevacizumab (Avastin) vs 2 biosimilars introduced on the US market starting in 2019: Mvasi, first marketed in July 2019, and Zirabev, first marketed in January 2020. The study period extended from January 2019 to July 2020 and enrolled patients with gastrointestinal cancer at Roswell Park Comprehensive Cancer Center at Buffalo, New York.
“Early recognition of uncontrolled blood pressures and worsening kidney function is needed to prevent delayed intervention,” investigators said, recommending routine monitoring of hypertension and proteinuria following treatment with bevacizumab.
Bevacizumab is a recombinant humanized monoclonal antibody that targets the development of blood vessels that support the growth of tumors. Hypertension and proteinuria, which can lead to pulmonary edema and affects kidney health, are adverse events of bevacizumab.
Investigators noted a higher risk of hypertension in the reference bevacizumab group (52.4% vs 36.4%), although this was not statistically significant (P = .2427). They observed hypertension in patients after a median of 5 doses of reference bevacizumab vs 1.5 doses of bevacizumab biosimilar (P = .0005).
Investigators observed a higher risk of proteinuria for patients treated with reference bevacizumab vs bevacizumab biosimilar (35.7% vs 30%), although this difference was not statistically significant (P = .7193). However, proteinuria occurred later in the treatment cycle with reference bevacizumab than with bevacizumab biosimilar (median, 213 days vs 53.5 days following the first bevacizumab dose; P = .0022).
Investigators concluded that the incidence of hypertension and proteinuria in patients treated with reference vs biosimilar bevacizumab requires study in larger patient cohorts.
Man Y, Yu H, Mukerjee S, Zalewski O. Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar. Presented at ASCO GI Cancers Symposium 2021; January 15-17, 2021. Accessed January 19, 2021. https://meetinglibrary.asco.org/record/194106/abstract