Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- PMID: 31693429
- PMCID: PMC7032881
- DOI: 10.1200/JCO.19.00172
Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Abstract
Purpose: Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) fare poorly, with limited treatment options. The antibody-drug conjugate polatuzumab vedotin targets CD79b, a B-cell receptor component.
Methods: Safety and efficacy of polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort. Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR) was compared with bendamustine and rituximab (BR) in a randomly assigned cohort of patients with transplantation-ineligible R/R DLBCL (primary end point: independent review committee [IRC] assessed complete response [CR] rate at the end of treatment). Duration of response, progression-free survival (PFS), and overall survival (OS) were analyzed using Kaplan-Meier and Cox regression methods.
Results: Pola-BG and pola-BR had a tolerable safety profile. The phase Ib/II pola-BG cohort (n = 27) had a CR rate of 29.6% and a median OS of 10.8 months (median follow-up, 27.0 months). In the randomly assigned cohort (n = 80; 40 per arm), pola-BR patients had a significantly higher IRC-assessed CR rate (40.0% v 17.5%; P = .026) and longer IRC-assessed PFS (median, 9.5 v 3.7 months; hazard ratio [HR], 0.36, 95% CI, 0.21 to 0.63; P < .001) and OS (median, 12.4 v 4.7 months; HR, 0.42; 95% CI, 0.24 to 0.75; P = .002; median follow-up, 22.3 months). Pola-BR patients had higher rates of grade 3-4 neutropenia (46.2% v 33.3%), anemia (28.2% v 17.9%), and thrombocytopenia (41% v 23.1%), but similar grade 3-4 infections (23.1% v 20.5%), versus the BR group. Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
Conclusion: Polatuzumab vedotin combined with BR resulted in a significantly higher CR rate and reduced the risk of death by 58% compared with BR in patients with transplantation-ineligible R/R DLBCL.
Trial registration: ClinicalTrials.gov NCT02257567.
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Comment in
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Polatuzumab Vedotin: Honing in on Relapsed or Refractory Diffuse Large B-Cell Lymphoma.J Clin Oncol. 2020 Jan 10;38(2):166-168. doi: 10.1200/JCO.19.02587. Epub 2019 Nov 26. J Clin Oncol. 2020. PMID: 31770050 No abstract available.
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LyRIC indeterminate response and Immune-mediated pseudoprogression of diffuse large B-cell lymphoma following polatuzumab-based salvage therapy.Br J Haematol. 2020 Jun;189(6):e248-e251. doi: 10.1111/bjh.16679. Epub 2020 Apr 27. Br J Haematol. 2020. PMID: 32342503 No abstract available.
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