The primary analysis showed significantly higher independent review committee (IRC) assessed complete response (CR) rates at end of treatment with pola-BR versus BR (40.0% v 17.5%; P = 0.026), with 90% concordance between the IRC and investigator.
After a median follow up of 27 months, overall survival (OS) was significantly improved in the pola-BR arm, with risk of death reduced by 58% (HR, 0.42; 95% CI, 0.24 to 0.75; P = .002) and a longer median OS with pola-BR (12.4 months; 95% CI, 9.0 to not evaluable) compared with BR alone (4.7 months; 95% CI, 3.7 to 8.3 months). Consistent benefit in risk reduction was seen for IRC and investigator -assessed progression free survival (PFS) (IRC: HR, 0.36; 95% CI, 0.21 to 0.63; P 0.001; INV: HR, 0.34; 95% CI, 0.20 to 0.57; P 0.001).r
(A) Progression-free survival by independent review committee. (B) Progression-free survival by investigator. (C) Overall survival of polatuzumab vedotin combined with bendamustine-obinutuzumab (pola-BR) compared with bendamustine-rituximab (BR). (D) Forest plot of overall survival according to clinical and biologic characteristics.
© JCO 2019