| Abstract: |
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. © 2024 Ferrata Storti Foundation. All rights reserved. |
| Keywords: |
adult; controlled study; event free survival; human tissue; protein expression; aged; major clinical study; overall survival; clinical trial; drug tolerability; neutropenia; drug efficacy; drug safety; systemic therapy; rituximab; positron emission tomography; follow up; antineoplastic agent; endometrium carcinoma; endometrium cancer; cancer immunotherapy; progression free survival; multiple cycle treatment; anemia; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; peripheral neuropathy; cohort analysis; bendamustine; risk factor; histology; monoclonal antibody; febrile neutropenia; pneumonia; antibodies, monoclonal; bone marrow biopsy; multicenter study; colon cancer; fluorodeoxyglucose f 18; chimeric antigen receptor; lymphoma, large b-cell, diffuse; phase 1 clinical trial; granulocyte colony stimulating factor; follicular lymphoma; lymphoma, follicular; cytopenia; adverse drug reaction; leukoencephalopathy; non-hodgkin lymphoma; antibody conjugate; immunoconjugates; septic shock; pneumocystis; acute myeloid leukemia; diffuse large b cell lymphoma; antibodies, monoclonal, humanized; refractory disease; disease burden; humans; human; male; female; article; obinutuzumab; polatuzumab vedotin; ecog performance status; bendamustine hydrochloride; chimeric antigen receptor t-cell immunotherapy
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