Polatuzumab Vedotin for Relapsed/Refractory Aggressive B-cell Lymphoma: A Multicenter Post-marketing Analysis

Smith, Stephen D.; Lopedote, Paolo; Samara, Yazeed; Mei, Matthew; Herrera, Alex F.; Winter, Allison M.; Hill, Brian T.; Shadman, Mazyar; Ujjani, Chaitra S.; Lynch, Ryan C.; Jacobson, Caron A.; Kim, Austin I.; Caimi, Paolo; Milano, Filippo; Gopal, Ajay K.

doi:10.1016/j.clml.2020.12.013

Cited by 20 publications

(23 citation statements)

References 16 publications

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“…Regarding the survival outcome, the median OS was 8.5 months in the total cohort and 24.0 months in patients achieving CR/PR. These durations are longer than those reported by Smith et al [16] and similar to those reported by Segman et al [15] (Table 3). In contrast, the OS in this study was shorter than that previously reported in clinical trials [1,28].…”

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

“…A few studies have described the treatment outcomes of PoV-based therapy in R/R DLBCL [1,15,16,28]. The ORR in these studies ranged from 42.0 to 61.7% (Table 3); the difference was probably due to the diversity of the patient cohorts, disease characteristics (de novo or transformed DLBCL), prior treatment lines, and treatment modalities (combination with rituximab, obinutuzumab, or BR) [1,15,16,28]. The ORR in our cohort was comparable to those in other cohort studies and better than that of the SCHOLAR-1 study or those previously reported with R-ICE, R-DHAP, or gemcitabine-based salvage therapy or even novel agents [15,16,29,30].…”

Section: Discussionmentioning

confidence: 99%

“…Polatuzumab vedotin (PoV) is a CD79b-targeted antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), a microtubule inhibitor, to CD79b-expressing cells [1,15,16]. Compared to rituximab-bendamustine (BR) alone, the combined use of PoV and BR (PoV-BR) immunochemotherapy resulted in a higher complete remission (CR) rate (40.0% vs. 17.5%) and longer progression-free survival (PFS; 9.5 vs. 3.7 months) and OS (12.4 vs. 4.7 months) in 40 relapsed/refractory (R/R) DLBCL patients [1].…”

Section: Introductionmentioning

confidence: 99%

“…Compared to rituximab-bendamustine (BR) alone, the combined use of PoV and BR (PoV-BR) immunochemotherapy resulted in a higher complete remission (CR) rate (40.0% vs. 17.5%) and longer progression-free survival (PFS; 9.5 vs. 3.7 months) and OS (12.4 vs. 4.7 months) in 40 relapsed/refractory (R/R) DLBCL patients [1]. In two previous real-world studies of PoV-BR, the overall response rate (ORR) was 50-60%, and the OS was approximately 5 ~ 8 months [15,16]. However, the literature describing prognostic factors for patients receiving PoV-based chemotherapy is scarce.…”

Section: Introductionmentioning

confidence: 99%

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Polatuzumab vedotin–based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience

et al. 2021

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Polatuzumab vedotin (PoV) has recently shown promising activity when combined with rituximab-bendamustine (BR) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, few studies have described the prognostic factors predicting response. Here, we aimed to evaluate the efficacy and safety profile of PoV-based chemotherapy, including regimens other than BR, as third-line or beyond treatment for patients with R/R DLBCL and to explore prognostic factors. Overall, 40 patients, including 37 with de novo and 3 with transformed DLBCL, were enrolled. The overall response rate was 52.5%, and 25% and 27.5% of patients showed a complete response and partial response, respectively. With a median follow-up of 18.8 months, the median overall survival (OS) of the total cohort was 8.5 months, and that of those receiving subsequent hematopoietic stem cell transplantation (HSCT) was 24 months. Low/intermediate risk according to the revised International Prognostic Index score at diagnosis and before PoV treatment predicted better OS. Furthermore, a normal lactate dehydrogenase level and an absolute lymphocyte count/absolute monocyte count ratio > 1.5 were favorable OS prognostic factors. The most common adverse event was cytopenia, with 42.5% of patients developing febrile neutropenia. Grade 1-3 peripheral neuropathy associated with PoV was reported in 25% of patients and resolved in most patients after the cessation of treatment. In summary, we demonstrated that PoV combined with either BR or other intensive chemotherapy is an effective and well-tolerated salvage option for patients with R/R DLBCL. Subsequent HSCT has the potential to further improve survival outcomes in this high-risk population. Clinicaltrials.gov number: NCT05006534.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Polatuzumab vedotin–based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience

et al. 2021

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Novel agents in relapsed/refractory diffuse large B‐cell lymphoma

Goldstein

Advani

2023

Hematological Oncology

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Patients with relapsed or refractory (R/R) diffuse large B‐cell lymphoma (DLBCL), ineligible for or relapsing after autologous stem‐cell transplant or chimeric antigen‐receptor T‐cell therapies have poor outcomes. Several novel agents, polatuzumab vedotin, tafasitamab, loncastuximab tesirine, and selinexor, have been approved and offer new opportunities for this difficult to treat population. Studies are evaluating combination of these agents with chemotherapy and other emerging therapies. Additionally, advances in our understanding of DLBCL biology, genetics, and immune microenvironment have allowed for the identification of new therapeutic targets like Ikaros and Aiolos, IRAK4, MALT1, and CD47 with several agents in ongoing clinical trials. In this chapter we review updated data supporting the use of the approved agents and discuss other emerging novel therapies for patients with R/R DLBCL.

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Poor outcomes for trial‐ineligible patients receiving polatuzumab for relapsed/refractory diffuse large B‐cell lymphoma in routine care: An Australian Lymphoma and Related Diseases Registry project

Shaw,

Chung,

Wellard

et al. 2024

eJHaem

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Polatuzumab vedotin (Pola) is an approved therapy in combination with rituximab and bendamustine for relapsed or refractory diffuse large B‐cell lymphoma (RR‐DLBCL) based on positive results of the landmark phase II randomised G029365 trial. However, trial results for many approved novel therapies in RR‐DLBCL have not been replicated in routine care cohorts, as RR‐DLBCL patient populations are heterogeneous and trial eligibility is increasingly restrictive. We evaluated outcomes from pola ± bendamustine and rituximab in patients with RR‐DLBCL enrolled in a compassionate access program with no alternative treatment options identified via the Australasian Lymphoma and Related Diseases Registry according to their eligibility for the original phase II published study. Of 58 eligible patients, 74% met the criteria deeming them ineligible for the G029365 original study at the time of pola's commencement. Median progression‐free survival and overall survival in our cohort were 2.3 and 3.5 months, respectively. In contrast to the landmark trial cohort, more of our patients ceased therapy prior to completion, the majority due to progressive disease and only 8/58 received any subsequent treatment. Dismal outcomes in this Australian real‐world population demonstrate trial eligibility is challenging to meet, and newer treatments can be difficult to deliver in routine care. Clinically applicable results from therapeutic studies require trial cohorts to reflect representative clinical populations wherever possible, and more research is required to address the benefit of novel agents in the increasing majority who are ineligible for modern studies.

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Polatuzumab Vedotin for Relapsed/Refractory Aggressive B-cell Lymphoma: A Multicenter Post-marketing Analysis

Cited by 20 publications

References 16 publications

Polatuzumab vedotin–based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience

Polatuzumab vedotin–based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience

Novel agents in relapsed/refractory diffuse large B‐cell lymphoma

Poor outcomes for trial‐ineligible patients receiving polatuzumab for relapsed/refractory diffuse large B‐cell lymphoma in routine care: An Australian Lymphoma and Related Diseases Registry project

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