Polatuzumab vedotin, venetoclax, and an anti-CD20 monoclonal antibody in relapsed/refractory B-cell non-Hodgkin lymphoma
- Author(s)
- Yuen, S; Phillips, TJ; Bannerji, R; Marlton, P; Gritti, G; Seymour, JF; Johnston, A; Arthur, C; Dodero, A; Sharma, S; Hirata, J; Musick, L; Flowers, CR;
- Details
- Publication Year 2024-07,Volume 99,Issue #7,Page 1281-1289
- Journal Title
- American Journal of Hematology
- Publication Type
- Research article
- Abstract
- The Phase 2 portion of this study evaluated safety and efficacy of polatuzumab vedotin 1.8 mg/kg and venetoclax 800 mg, plus fixed-dose obinutuzumab 1000 mg or rituximab 375 mg/m(2) in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), respectively. Patients with complete response (CR) or partial response (PR)/stable disease (FL) or CR/PR (DLBCL) at end of induction (EOI; six 21-day cycles) received post-induction therapy with venetoclax and obinutuzumab or rituximab, respectively. Primary endpoint was CR rate at EOI. Safety-evaluable populations included 74 patients (FL cohort; median age 64 years; progression of disease within 24 months on first-line treatment, 25.7%; FL International Prognostic Index 3-5, 54.1%; ≥2 previous therapies, 74.3%) and 57 patients (DLBCL cohort; median age 65 years; International Prognostic Index 3-5, 54.4%; ≥2 previous therapies, 77.2%). The most common non-hematologic adverse events (mostly Grades 1-2) in the FL and DLBCL cohorts were diarrhea (55.4% and 47.4%, respectively) and nausea (47.3% and 36.8%); neutropenia was the most common Grades 3-4 toxicity (39.2% and 52.6%). Efficacy-evaluable populations included patients treated at the recommended Phase 2 dose (FL, n = 49; DLBCL, n = 48). CR rates at EOI were 59.2% (FL) and 31.3% (DLBCL); median progression-free survival was 22.8 months (95% confidence interval [CI], 14.5-not evaluable) and 4.6 months (95% CI, 3.6-8.1), respectively. Polatuzumab vedotin plus venetoclax and obinutuzumab/rituximab had acceptable safety in patients with R/R FL or DLBCL, with promising response rates in R/R FL, including high-risk patients.
- Publisher
- Wiley
- Keywords
- Humans; Middle Aged; Aged; Male; *Sulfonamides/administration & dosage/therapeutic use/adverse effects; Female; *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse; effects/administration & dosage; *Bridged Bicyclo Compounds, Heterocyclic/therapeutic use/administration &; dosage/adverse effects; *Lymphoma, Large B-Cell, Diffuse/drug therapy; *Antibodies, Monoclonal, Humanized/therapeutic use/administration &; dosage/adverse effects; Adult; Aged, 80 and over; *Rituximab/administration & dosage/therapeutic use/adverse effects; Lymphoma, Follicular/drug therapy; Antibodies, Monoclonal/therapeutic use/administration & dosage/adverse effects; Recurrence; Immunoconjugates
- Department(s)
- Clinical Haematology
- Publisher's Version
- https://doi.org/10.1002/ajh.27341
- Open Access at Publisher's Site
https://doi.org/10.1002/ajh.27341- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-08-27 07:14:46
Last Modified: 2024-08-27 07:28:18