Based on the information available, there is evidence supporting the use of Polivy (generic name: polatuzumab vedotin) in certain therapeutic contexts. Polivy is an FDA-approved antibody-drug conjugate indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and a rituximab product [1].
A pivotal phase Ib/II study, GO29365, investigated the safety and efficacy of polatuzumab vedotin in combination with bendamustine and rituximab (pola-R-B) in patients with relapsed or refractory DLBCL [2]. The results demonstrated that pola-R-B significantly improved the overall response rate (ORR) and complete response rate (CRR) compared to rituximab plus bendamustine alone [2].
Another phase III trial, the Pola-R-CHP study, compared polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) to standard R-CHOP in previously untreated DLBCL patients [3]. The study met its primary endpoint, demonstrating that pola-R-CHP significantly improved progression-free survival (PFS) compared to R-CHOP [3].
In summary, the available information from DrugPatentWatch.com and other sources indicates that there are two key clinical trials supporting the use of Polivy (polatuzumab vedotin) in the treatment of DLBCL [1][2][3]:
1. GO29365: A phase Ib/II study investigating polatuzumab vedotin in combination with bendamustine and rituximab in relapsed or refractory DLBCL patients.
2. Pola-R-CHP: A phase III trial comparing polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone to standard R-CHOP in previously untreated DLBCL patients.
Sources:
[1] <https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761156s000lbl.pdf>
[2] <https://ascopubs.org/doi/abs/10.1200/JCO.18.00540>
[3] <https://ascopubs.org/doi/abs/10.1200/JCO.21.00532>