Expert Insights on Pooled Safety Data from the PRONTO and VITAL trials

Opinion
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Vaishali Sanchorawala, MD, provides insights on the pooled safety analysis of data from phase 1 to 3 trials, including PRONTO and VITAL, which investigated the use of birtamimab in patients with light chain (AL) amyloidosis.

This is a video synopsis/summary of a Peer Exchange involving Heather Landau, MD; Vaishali Sanchorawala, MD; and Jeffrey Zonder, MD.

A forthcoming presentation at the American Society of Hematology meeting will feature a pooled safety analysis of the phase 2 PRONTO, phase 3 VITAL, and open-label extension trials, examining data from 302 patients with a median exposure of 12.2 months to birtamimab. The analysis indicates no significant differences in all-cause or treatment-related adverse events between birtamimab-treated and placebo-treated patients in the PRONTO and VITAL trials. This reaffirms the overall safety and high tolerance of birtamimab, aligning with prior experiences. The primary objective of these studies is to discern the patient populations that derive the most benefit from this treatment, emphasizing the importance of ongoing research in defining optimal usage.

Video synopsis is AI-generated and reviewed by OncLive® editorial staff.

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