Home Gastrointestinal Reviewers Consider “Totality of Evidence” for Mvasi

Reviewers Consider “Totality of Evidence” for Mvasi

57
0

Reviewers evaluating the “totality of evidence” for the bevacizumab biosimilar Mvasi (ABP 215) found “no clinically meaningful differences” between the biosimilar and its reference product, and they also concluded “robust data” from multiple trials support extrapolation to all indications of the reference product.

Mvasi is approved in the United States and European Union for several oncology indications, including metastatic colorectal cancer, metastatic cervical cancer, and metastatic nonsquamous non–small cell lung cancer (NSCLC). The authors stated they had no role in any of the human or animal studies included in their review.

Mvasi, an Amgen product, is a monoclonal antibody that binds with vascular endothelial growth factor A (VEGF-A) to retard blood vessel growth that contributes to tumor development. Mvasi was the first bevacizumab biosimilar approved in the United States (2017) and European Union (2018). In the United States, the biosimilar was launched in July 2019.

Analytical Similarity

According to the authors, analytical tests that compared Mvasi with reference product samples from the United States and European Union showed biosimilarity in physicochemical properties, including primary structure, secondary structure, and thermal stability.

Functional properties also were similar. The authors outlined studies that demonstrated Mvasi’s comparable binding affinity to VEGF, inhibition of VEGF binding to its receptor, and inhibition of proliferation of endothelial cells in vitro. “These findings indicate that [Mvasi] and the [reference product] have the same mechanism of action (MOA),” the authors wrote.

Pharmacokinetics

The authors cited 2 studies in healthy individuals that indicated comparable pharmacokinetic properties between Mvasi and its reference product. Safety and tolerability in these studies also were similar. None of the enrollees developed binding or neutralizing antidrug antibodies, investigators said.

Comparative Clinical Study

A comparative clinical trial (MAPLE) involving 642 patients with stage IV or recurrent nonsquamous NSCLC who also received carboplatin and paclitaxel also demonstrated biosimilarity. The primary efficacy end point was the risk ratio of objective response rate (ORR, defined as best overall response). Objective responses were observed in 39.0% and 41.7% of patients receiving Mvasi and reference product, respectively, and the 2-sided confidence interval for ORR fell within the prespecified margin, indicating similar clinical efficacy.

Safety and immunogenicity indicators were also similar between groups. Among patients receiving Mvasi, 26.2% experienced a serious adverse event (AE), vs 23.0% for the reference product cohort; 18.8% and 17.2% of patients on Mvasi and the reference product, respectively, experienced an AE leading to discontinuation.

Anti-VEGF toxicities, such as hypertension, gastrointestinal perforation, or wound healing complications were similar between groups. Immunogenicity was low in both treatment groups, with 1.4% in the Mvasi group and 2.5% in the reference product group developing antidrug antibodies, which were transient in 1.0% and 1.1% of subjects, respectively. No patients tested positive for neutralizing antibodies.

Totality of Evidence

The authors concluded the totality of evidence supports the extrapolation of Mvasi to all approved indications of the reference product, as “no clinically meaningful differences were found in function, purity, potency, PK, clinical efficacy, safety, or immunogenicity.”

They said these studies “should provide oncologists with assurance about using [Mvasi] in treating all approved indications per the prescribing information in their country or region.”

https://www.centerforbiosimilars.com/view/reviewers-consider-totality-of-evidence-for-mvasi

This site uses Akismet to reduce spam. Learn how your comment data is processed.