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Polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas.

ABSTRACT: The antibody-drug conjugate polatuzumab vedotin (pola) has recently been approved in combination with bendamustine and rituximab (pola-BR) for patients with refractory or relapsed (r/r) large B-cell lymphoma (LBCL). To investigate the efficacy of pola-BR in a real-world setting, we retrospectively analyzed 105 patients with LBCL who were treated in 26 German centers under the national compassionate use program. Fifty-four patients received pola as a salvage treatment and 51 patients were treated with pola with the intention to bridge to chimeric antigen receptor (CAR) T-cell therapy (n = 41) or allogeneic hematopoietic cell transplantation (n = 10). Notably, patients in the salvage and bridging cohort had received a median of 3 prior treatment lines. In the salvage cohort, the best overall response rate was 48.1%. The 6-month progression-free survival and overall survival (OS) was 27.7% and 49.6%, respectively. In the bridging cohort, 51.2% of patients could be successfully bridged with pola to the intended CAR T-cell therapy. The combination of pola bridging and successful CAR T-cell therapy resulted in a 6-month OS of 77.9% calculated from pola initiation. Pola vedotin-rituximab without a chemotherapy backbone demonstrated encouraging overall response rates up to 40%, highlighting both an appropriate alternative for patients unsuitable for chemotherapy and a new treatment option for bridging before leukapheresis in patients intended for CAR T-cell therapy. Furthermore, 7 of 12 patients with previous failure of CAR T-cell therapy responded to a pola-containing regimen. These findings suggest that pola may serve as effective salvage and bridging treatment of r/r LBCL patients.

SUBMITTER: Liebers N

PROVIDER: S-EPMC8288676 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTo inform healthcare professionals, payers and health technology organisations of estimated survival benefits of new treatments, statistical methods can be used to model the projected clinical benefits versus costs of new interventions. This is particularly relevant for new treatments where data describing all progression events are incomplete and long-term survival outcomes are not yet established. In patients with the fast-growing B-cell cancer, diffuse large B-cell lymphoma (DLBCL), heterogeneous clinical efficacy outcomes are observed with the presence of both 'cured' (long-term survivors [LTS]) and 'non-cured' patients. Mixture cure rate models represent an alternative approach to traditional standard parametric survival models as they capture this heterogeneity. The aim of this analysis was to use progression-free survival (PFS) as an intermediate endpoint to estimate long-term survival with polatuzumab vedotin (Pola) + bendamustine (B) + rituximab (R) treatment (Pola+BR); these survival estimates will be utilised to inform future economic analyses.MethodsUsing data from the Phase II randomised cohort of the GO29365 trial (NCT02257567), we estimated the overall survival (OS) benefit and proportion of LTS with Pola+BR versus BR alone in patients with relapsed/refractory (R/R) DLBCL. Alongside standard parametric survival models, a mixture cure rate model was evaluated for each treatment arm, exploring both OS and OS informed by PFS.ResultsThe estimated mean OS was 3.78 years for Pola+BR versus 1.07 years for BR using standard parametric methods and 4.00 years versus 1.02 years using a mixture cure rate model (OS informed by PFS). The proportion of LTS using the mixture cure rate model was 23.0% (95% confidence interval: 9.3, 45.36) for Pola+BR versus 0% for BR (assuming a generalised gamma distribution). Of the extrapolation methods tested, mixture cure rate model predictions were best aligned with the observed survival data in GO29365.ConclusionsThese models suggest that compared with BR alone, Pola+BR is associated with a higher proportion of LTS ranging from 22.0 to 26.6%, depending on the distribution assumed. However, the upper and lower limits of the confidence intervals of the point estimates are reaching from 9 to 45%.

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Polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas.

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