The combination of atezolizumab and BCG in high-risk non-muscle invasive bladder cancer: results of the phase Ib/II BladderGATE clinical trial.
Guerrero-Ramos, Félix F; Gómez-Cañizo, Carmen C; Rodríguez-Izquierdo, Marta M; et al.
In a phase Ib/II open‑label trial of 36 BCG‑naïve high‑risk non‑muscle invasive bladder cancer patients (median age 70), intravenous atezolizumab combined with intravesical BCG was tolerable with no dose‑limiting toxicities and low incidence of serious drug‑related adverse events. Median recurrence‑free survival was not reached, with RFS rates of 83% at 1 year and 73% at 2 years, no observed impairment in health‑related quality of life, and results reported as consistent with the ALBAN study which did not show a clear benefit over BCG alone.