Outcome of relapsed/refractory diffuse large B-cell lymphoma patients treated with polatuzumab vedotin-based therapy: real-life experience

Segman, Yafit; Ribakovsky, Elena; Avigdor, Abraham; Goldhecht, Yair; Vainstein, Vladimir; Goldschmidt, Neta; Harlev, Shimrit; Horwitz, Netanel A; Gutwein, Odit; Gurion, Ronit; Itchaki, Gilad; Abadi, Uri; Nemets, Anatoly; Sofer, Orit; Zektser, Miri; Tadmor, Tamar; Dally, Nagib; Filanovsky, Kalman; Leiba, Merav; Sarid, Nadav; Benyamini, Noam; Herishanu, Yair; Ram, Ron; Perry, Chava; Avivi, Irit

doi:10.1080/10428194.2020.1824069

Cited by 27 publications

(39 citation statements)

References 15 publications

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“…These patients were excluded from the approval study. A similar trend of a worse outcome in a real-world study of pola was reported by Segman et al 22 Although outcomes in real-world settings may not be as promising as demonstrated in the approval study, pola still may have a valuable role to play in LBCL salvage therapy, even in patients following several failed treatment lines. Despite the adverse baseline characteristics, the moderate toxicity profile of pola was confirmed in this study.…”

Section: Discussionsupporting

confidence: 75%

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

et al. 2021

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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.

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Section: Discussionsupporting

confidence: 75%

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

et al. 2021

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“…Treatment was generally well tolerated, and the safety profile was similar to those reported by others as were the ORR (61%) and complete response rate (CR) (40%). Interestingly, the ORR in patients receiving P-B ± R was comparable to those who received P-R (62.5% vs 60%) [107] and mirrored those reported for the Romulus trial. These results support the positive clinical benefit of Polivy and have prompted the expanded testing of combinations of this ADC with other drugs and for other CD79b+ HMs are also being tested.…”

Section: Clinical Efficacysupporting

confidence: 72%

Antibody‐Drug‐Conjugate Therapy for Hematological Cancers: Matching Cell Biology with Clinical Benefit

Firer

Luboshits

2021

Adv Funct Materials

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Progress in the development and clinical efficacy of antibody-drug conjugates (ADCs) has attracted the interests of both academic researchers and the industry. The rationale for developing ADCs is based on the inherent nonselectivity of chemotherapy for tumor cells, leading to side effects that can be severe and life threatening. Another major consequence of chemotherapy is the development of drug resistance. For these reasons, targeted drug delivery (TDD) systems are being developed to specifically deliver the cytotoxic drug into the target cell. A variety of carriers that can deliver drugs to the surface or into cancer cells, one of which is the use of monoclonal antibodies, with to date ten ADCs having received FDA approval. This review will focus on the development and clinical application of five ADCs currently approved for the treatment of hematological malignancies. Following a short history that led to their regulatory approval, the review will focus on the important link between the biology of the ADC, the cell surface component targeted by the antibody component, and clinical efficacy and conclude by highlighting newer developments that strengthen this link, so that ADCs can provide long-term clinical benefit to patients with hematological cancers.

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“…Only two (3.3%) patients of the present cohort had received only 1 previous treatment line versus 27.5% in the GO29365 study and by definition none in the Israeli series 34 ,. 40 At Pola‐BR initiation 40% of our patients had PS ≥ 2 versus 15% in the GO29365 trial and 53% in the Israeli cohort. Our cohort included also 14 (25%) patients with PS 3–4, an exclusion criterion for the GO29365 trial, while the Israeli cohort included such patients without reporting precise numbers.…”

Section: Discussionmentioning

confidence: 80%

“…The vast majority of our patients had DLBCL and 49 DLBCL patients received Pola‐BR, being eligible for efficacy analysis. The recently published Israeli real‐life experience with Pola‐BR included 31 rrDLBCL patients, with 23 receiving Pola‐BR 40 . Compared to the GO29365 study and the Israeli cohort, our patients were slightly younger with a median age of 63 years versus 67 and 66.4 years respectively.…”

Section: Discussionmentioning

confidence: 90%

Real‐life experience with the combination of polatuzumab vedotin, rituximab, and bendamustine in aggressive B‐cell lymphomas

Dimou

Papageorgiou

Stavroyianni

et al. 2021

Hematological Oncology

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Transplant‐ineligible relapsed/refractory (rr) diffuse large B‐cell lymphoma (DLBCL) patients represent an unmet medical need. Polatuzumab vedotin (Pola), an anti‐CD79b antibody‐drug‐conjugate (ADG), with bendamustine‐ rituximab(BR) has recently gained approval for these patients, both in the USA and Europe, based on the GO29365 phase IIb trial. Real‐life data with Pola are extremely limited. We report the outcomes of 61 Greek patients, who received Pola‐(B)R mainly within a compassionate use program. Treatment was given for up to six 21‐day cycles. Bendamustine was omitted in three cases due to previous short‐lived responses. Fourty‐nine rrDLBCL(efficacy cohort‐EC) and 58 rr aggressive B‐NHL (safety cohort‐SC) patients received at least 1 Pola‐BR cycle. Twenty‐one (43%) patients of the EC responded with 12/49 (25%) CR and 9/49 (18%) PR as best response. Median progression–free survival, overall survival and duration of response were 4.0, 8.5, and 8.5 months respectively, while 55% of patients experienced a grade ≥3 adverse event, mainly hematologic. Treatment discontinuations and death during treatment were mainly due to disease progression. Twenty‐two (41%) patients received further treatment; 11/22 are still alive, including one after CAR‐T cells, and two after stem cell transplantation. Our data confirm that Pola‐BR is a promising treatment for rrDLBCL patients, inducing an adequate response rate with acceptable toxicity. Pola‐BR could be used as bridging therapy before further consolidative treatments.

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Outcome of relapsed/refractory diffuse large B-cell lymphoma patients treated with polatuzumab vedotin-based therapy: real-life experience

Cited by 27 publications

References 15 publications

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

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

Antibody‐Drug‐Conjugate Therapy for Hematological Cancers: Matching Cell Biology with Clinical Benefit

Real‐life experience with the combination of polatuzumab vedotin, rituximab, and bendamustine in aggressive B‐cell lymphomas

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