Expert Insights on Pooled Safety Data from the PRONTO and VITAL trials
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.
EP: 1.Exploring the Landscape Surrounding Light Chain Amyloidosis
EP: 2.Expert Perspectives on Differentiating Signs and Symptoms in AL Amyloidosis Diagnosis
EP: 3.Exploring Diagnostic Approaches for Patients with Light Chain Amyloidosis
EP: 4.Current Treatment Landscape for AL Amyloidosis
EP: 5.Unmet Needs and Treatment Considerations in Managing AL Amyloidosis
EP: 6.Treatment Strategies Using Monoclonal Antibodies in AL Amyloidosis
EP: 7.Optimizing Treatment Management Strategies in AL Amyloidosis with CD38-Directed mAbs
EP: 8.Addressing Challenges in Managing AL Amyloidosis with Cardiac Involvement
EP: 9.The Role of Cardiac Staging in Patients with AL Amyloidosis
EP: 10.Novel Treatment Approaches with mAbs Targeting Amyloid Deposits: Insights from VITAL
EP: 11.AFFIRM-AL: Birtamimab in Patients with Mayo Stage IV AL Amyloidosis
EP: 12.Expert Insights on Pooled Safety Data from the PRONTO and VITAL trials
EP: 13.The Potential Role of CAR T Therapy in AL Amyloidosis
EP: 14.NEXICART-1: Safety and Efficacy of NXC-201 in AL Amyloidosis
EP: 15.Looking Ahead: Future Perspectives on 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.
