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Clinical Trial
. 2024 Feb 1;109(2):553-566.
doi: 10.3324/haematol.2023.283480.

Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study

Johannes Duell  1 , Pau Abrisqueta  2 , Marc Andre  3 , Gianluca Gaidano  4 , Eva Gonzales-Barca  5 , Wojciech Jurczak  6 , Nagesh Kalakonda  7 , Anna Marina Liberati  8 , Kami J Maddocks  9 , Tobias Menne  10 , Zsolt Nagy  11 , Olivier Tournilhac  12 , Christian Kuffer  13 , Abhishek Bakuli  13 , Aasim Amin  13 , Konstantin Gurbanov  13 , Gilles Salles  14
Affiliations
Clinical Trial

Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study

Johannes Duell et al. Haematologica. .

Abstract

Tafasitamab, an anti-CD19 immunotherapy, is used with lenalidomide for patients with autologous stem cell transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma based on the results of the phase II L-MIND study (NCT02399085). We report the final 5-year analysis of this study. Eighty patients ≥18 years who had received one to three prior systemic therapies, and had Eastern Cooperative Oncology Group performance status 0-2 received up to 12 cycles of co-administered tafasitamab and lenalidomide, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. The primary endpoint was the best objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival, and safety. Exploratory analyses evaluated efficacy endpoints by prior lines of therapy. At data cutoff on November 14, 2022, the objective response rate was 57.5%, with a complete response rate of 41.3% (n=33), which was consistent with prior analyses. With a median follow-up of 44.0 months, the median duration of response was not reached. The median progression-free survival was 11.6 months (95% confidence interval [95% CI]: 5.7-45.7) with a median follow-up of 45.6 months. The median overall survival was 33.5 months (95% CI: 18.3-not reached) with a median follow-up of 65.6 months. Patients who had received one prior line of therapy (n=40) showed a higher objective response rate (67.5%; 52.5% complete responses) compared to patients who had received two or more prior lines of therapy (n=40; 47.5%; 30% complete responses), but the median duration of response was not reached in either subgroup. Other exploratory analyses revealed consistent long-term efficacy results across subgroups. Adverse events were consistent with those described in previous reports, were manageable, and their frequency decreased during tafasitamab monotherapy, with no new safety concerns. This final 5-year analysis of L-MIND demonstrates that the immunotherapy combination of tafasitamab and lenalidomide is well tolerated and has long-term clinical benefit with durable responses.

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Figures

Figure 1.
Figure 1.
Kaplan-Meier curves of time-to-event endpoints. (A) Duration of response in the overall group and in subgroups divided according to the number of prior lines of therapy. (B) Progression-free survival in the overall group and in subgroups divided according to the number of prior lines of therapy. (C) Overall survival in the overall group and in subgroups divided according to the number of prior lines of therapy. (D) Duration of complete response in the overall group and in subgroups divided according to the number of prior lines of therapy. (E) Overall survival according to best response in patients with a best response of complete response or partial response in the overall group. (F) Overall survival according to natural killer cell count < or ≥100 cells/mL of peripheral blood. DoR: duration of response; mFU: median follow-up; 95% CI: 95% confidence interval; pLoT: prior line(s) of therapy; mDoR: median DoR; NR: not reached; PFS: progression-free survival; mPFS: median PFS; OS: overall survival; mOS: median OS; DoCR: duration of complete response; mDoCR: median DoCR; CR: complete response; PR: partial response; NK: natural killer cell count.
Figure 2.
Figure 2.
Time under treatment and outcomes in patients who ended treatment with a response (N=26). Per protocol, the first computed tomography or magnetic resonance imaging scan for tumor measurement and disease assessment (local) was on day 1 of cycle 3 (~2 months), and the first disease and disease response assessment (computed tomograpy/positron emission tomography) was on day 28 of cycle 12. COO: cell of origin; Refract.: refractory disease; GCB: germinal center B cell; LastL: disease refractory to last line of therapy (but not primary refractory); miss.: missing; Prim.: primary refractory disease; PET: positron emission tomography.
Figure 3.
Figure 3.
Five-year objective response rate in subgroups of clinical interest. FAS: full analysis set; GCB: germinal center B cell; IPI: International Prognostic Index; LDH: lactate dehydrogenase; NK: natural killer; Prim. Refr.: primary refractory; mths: months; ORR: objective response rate.
Figure 4.
Figure 4.
Exposure-adjusted comparison of the frequencies of treatment-emergent adverse events during the combined tafasitamab + lenolamide treatment period, during tafasitamab monotherapy up to 2 years, and during tafasitamab monotherapy beyond 2 years. (A) All treatment-emergent adverse events (TEAE). (B) Hematologic TEAA. (C) Non-hematologic TEAE (cutoff: ≥10 events in any treatment period. (D) Important TEAE of interest. LEN: lenalidomide.
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References

    1. World Health Organization. World Cancer Report: Cancer Research for Cancer Prevention. IARC Press; 2020.
    1. Sarkozy C, Sehn LH. New drugs for the management of relapsed or refractory diffuse large B-cell lymphoma. Ann Lymphoma. 2019;3:310.
    1. Crump M, Neelapu SS, Farooq U, et al. . Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808. - PMC - PubMed
    1. Locke F, Miklos DB, Jacobson C, et al. . Primary analysis of ZUMA 7: a phase 3 randomized trial of axicabtagene ciloleucel (axi-cel) versus standard of care therapy in patients with relapsed/ refractory large B-cell lymphoma. Blood. 2021;138(Suppl 1):2.
    1. Kamdar M, Solomon SR, Arnason J, et al. . Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis. Lancet. 2022;399(10343):2294-2308. - PubMed

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