(Length of conversation: 14 minutes)

Alicia Morgans and Arjun Balar converse on the long-term efficacy data of atezolizumab in the 1st line setting as well as the 2nd line setting from the single-arm phase 2 trial. Discussion evolves to the recent safety alerts by the FDA highlighting the two studies, Keynote 361 and IMvigor 130.  They question the applicability to clinical practice and the challenges related to the use of assays and biomarker testing in this patient population.

Views are shared regarding the possible FDA response to the recent ruling from CHMP recommendation to the EMA on IOs in first-line therapy for bladder cancer.

Biographies:  
Arjun V. Balar, MD Assistant Professor, Department of Medicine, Director, Genitourinary Medical Oncology Program at NYU Langone’s Perlmutter Cancer Center

Alicia Morgans, MD, MPH