| Autor: |
Flowers CR; Winship Cancer Institute of Emory University, Atlanta, GA. CRFlowers@mdanderson.org., Matasar MJ; Memorial Sloan Kettering Cancer Center, New York, NY., Herrera AF; City of Hope Medical Centre, Duarte, CA., Hertzberg M; Prince of Wales Hospital and University of NSW, Sydney., Assouline S; Jewish General Hospital, Montreal, QC., Demeter J; Semmelweiss University, Budapest, Hungary., McMillan A; Center for Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham., Mehta A; University of Alabama at Birmingham, Birmingham., Opat S; Clinical Haematology, Monash Health and Monash University, Clayton., Trnňný M; Charles University General Hospital, Prague, Czech Republic., Musick L; Genentech, Inc., South San Francisco, CA., Hirata J; Genentech, Inc., South San Francisco, CA., Yang A; Genentech, Inc., South San Francisco, CA., Sehn LH; BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, BC. |
| Abstrakt: |
Follicular lymphoma (FL) is the most common type of indolent non-Hodgkin lymphoma. Despite treatment advances that have improved outcomes for patients with relapsed or refractory (R/R) FL, many patients still die from progressive disease or treatment-related toxicities. In the phase Ib/II GO29365 study (clinicaltrials.gov 02257567), the safety and efficacy of polatuzumab vedotin plus bendamustine and rituximab (Pola-BR) versus bendamustine and rituximab (BR) alone, and polatuzumab vedotin plus bendamustine and obinutuzumab (Pola-BG) as a single-arm cohort were evaluated in patients with R/R FL. Following the phase Ib safety run-in, patients were randomized 1:1 to receive Pola-BR or BR alone in the phase II stage; a separate non-randomized Pola-BG cohort was examined in the phase Ib/II expansion stage. Primary endpoints included safety and tolerability (phase Ib) and positron emission tomography complete response (PET-CR) rate by independent review committee (phase II). Overall, 112 patients were enrolled (phase Ib safety run-in: Pola-BR, N=6; phase II randomized cohort: Pola-BR, N=39; BR, N=41; phase Ib/II expansion cohort: Pola-BG, N=26). PET-CR rates were 66.7% (phase Ib safety run-in, Pola-BR); 69.2% (phase II randomized, Pola-BR); 63.4% (phase II randomized, BR); and 65.4% (phase Ib/II expansion Pola-BG). There was a higher occurrence of cytopenias with Pola-BR and Pola-BG than with BR; serious adverse events were more frequent with Pola-BR (61.4%) and Pola-BG (46.2%) than with BR (29.3%). Overall, this analysis does not demonstrate a benefit of adding Pola to BR or BG regimens for patients with R/R FL. |
