Polivy (polatuzumab vedotin-piiq)

POLA demonstrated robust single-agent antitumor activity in vivo, including in PDX models derived from patients with ibrutinib-resistant MCL. This signature likely reflects core pathways associated with POLA resistance and highlights potential novel therapeutic vulnerabilities. These findings strongly support further clinical investigation of POLA in combination with VEN as a BCL2- and MCL1-targeting therapeutic strategy in patients with R/R MCL and BCL2-positive R/R DLBCL.

P1, N=34, Active, not recruiting, National Cancer Institute (NCI) | N=55 --> 34 | Recruiting --> Active, not recruiting

P2, N=35, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P2, N=178, Not yet recruiting, Ruijin Hospital

Previous studies have shown that the combination of the second-generation BTKi zanubrutinib and polatuzumab vedotin, within the R-CHOP regimen, yielded higher response rates in preliminary clinical studies; however, the efficacy of this combination remains unclear. Notably, the combination showed superior synergistic efficacy in GCB-subtype cells. In conclusion, these findings provide a novel mechanistic rationale for combining zanubrutinib and polatuzumab vedotin in DLBCL treatment, regardless of cell-of-origin subtype.

P2, N=47, Not yet recruiting, Australasian Leukaemia and Lymphoma Group

P3, N=1000, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

P2, N=30, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting

P2, N=213, Recruiting, Miltenyi Biomedicine GmbH | Active, not recruiting --> Recruiting | N=45 --> 213

P2, N=40, Recruiting, University Health Network, Toronto | Trial primary completion date: Nov 2025 --> Nov 2027

P2, N=48, Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi

P2, N=42, Peking Union Medical College Hospital; Peking Union Medical College Hospital