Rapid tumor reduction poses a risk for TLS during the 5-week ramp-up phase 1

  • TLS including fatal events and renal failure requiring dialysis, occurred in previously treated CLL patients with high tumor burden treated with VENCLEXTA
  • Two fatal events and 3 events of acute renal failure, 1 requiring dialysis, occurred before the implementation of the ramp-up dosing regimen and prophylactic and monitoring measures designed to reduce the risk of TLS
  • These fatal events occurred in the initial phase 1 dose-finding trials

Implementation of ramp-up dosing, prophylaxis, and monitoring reduced the incidence of TLS

Incidence of TLS

TLS after implementation