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Clinical Trial
. 2023 Aug 22;7(16):4435-4447.
doi: 10.1182/bloodadvances.2022009575.

Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study

Emmanuel Bachy  1 , Kerry J Savage  2 , Huiqiang Huang  3 , Yok-Lam Kwong  4 , Giuseppe Gritti  5 , Qingyuan Zhang  6 , Anna Marina Liberati  7 , Junning Cao  8 , Haiyan Yang  9 , Siguo Hao  10 , Jianda Hu  11 , Keshu Zhou  12 , Mario Petrini  13 , Filomena Russo  14 , Huilai Zhang  15 , Wei Sang  16 , Jie Ji  17 , Andrés José María Ferreri  18 , Gandhi Laurent Damaj  19 , Hui Liu  20 , Wei Zhang  21 , Xiaoyan Ke  22 , Chiara Ghiggi  23 , Sha Huang  24 , Xiaotong Li  24 , Hui Yao  24 , Jason Paik  25 , William Novotny  25 , Wenxiao Zhou  24 , Hongjie Zhu  24 , Pier Luigi Zinzani  26   27
Affiliations
Clinical Trial

Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study

Emmanuel Bachy et al. Blood Adv. .

Abstract

Patients with relapsed/refractory (R/R) mature T- and natural killer (NK)-cell neoplasms lack effective treatments after failure of standard therapies. This phase 2 study evaluated the efficacy and safety of the programmed cell death protein 1 inhibitor tislelizumab in these patients. Seventy-seven patients were treated with 200 mg tislelizumab every 3 weeks. Twenty-two patients with extranodal NK-/T-cell lymphomas were enrolled in cohort 1; 44 patients with peripheral T-cell lymphoma (PTCL) were enrolled in cohort 2 (21 patients had PTCL not otherwise specified, 11 patients had angioimmunoblastic T-cell lymphoma, and 12 patients had anaplastic large-cell lymphoma). Cohort 3 comprised 11 patients with cutaneous T-cell lymphoma, of which 8 patients had mycosis fungoides (MF) and 3 had Sézary syndrome. Of the 77 patients, 76.6% had advanced-stage disease, 51.9% had refractory disease, and 49.4% received ≥3 prior systemic regimens. Promising efficacy was observed in cohort 3 (median follow-up [FU], 16.6 months; overall response rate [ORR], 45.5%; complete response [CR], 9.1%; median duration of response [DOR], 11.3 months; median progression-free survival, 16.8 months; median overall survival, not reached). Modest efficacy was observed in cohort 1 (median FU, 8.4 months; ORR, 31.8%; CR, 18.2%; median DOR, not reached) and cohort 2 (median FU, 9.3 months; ORR, 20.5%; CR, 9.1%; median DOR, 8.2 months). Most treatment-related adverse events were grade 1 or 2, and the safety profile was consistent with the known safety profile of tislelizumab. In conclusion, tislelizumab was well tolerated, achieving modest efficacy in R/R mature T- and NK-cell neoplasms, with some long-lasting remissions. This trial was registered at www.clinicaltrials.gov as #NCT03493451.

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Conflict of interest statement

Conflict-of-interest disclosure: E.B. reports serving on advisory boards for Roche, Takeda, Bristol Myers Squibb (BMS), and Incyte, and honoraria from Novartis, Kite/Gilead, and Roche. K.J.S. reports honoraria/consulting from Seattle Genetics, Merck, BMS, Janssen, Kyowa, AstraZeneca, Novartis, and Incyte, and serves on steering committees for BeiGene, and Data and Safety Monitoring Committees for Regeneron. Y.L.K. reports consultancy for Amgen, Astellas, Bayer, BeiGene, BMS, Celgene, Janssen, Merck, Novartis, Roche, and Takeda, and receives educational funds from Novartis. G.G. reports consulting/advisory fees from Takeda, Gilead Sciences, IQVIA, Clinigen Group, Roche, and Italfarmaco; receives travel expenses from Janssen and Gilead Sciences; and serves on speakers’ bureaus for Amgen and Roche. A.M.L. reports sponsored research support related to this publication from BeiGene to her institution; sponsored research to her institution from Takeda, Servier, Roche, Celgene, AbbVie, Incyte, Janssen, Sanofi, Verastem, Novartis, MorphoSys, GlaxoSmithKline, Oncopeptides, Karyopharm, Onconova, Archigen, Pfizer, and Fibrogen; honoraria from IQVIA, Servier, Celgene, AbbVie, BMS, and Janssen; travel expenses from Takeda, Roche, Janssen, Celgene, BMS, AbbVie, Novartis, Sanofi, IQVIA, and Verastem; and participation in Amgen and Servier data safety monitoring or advisory boards. A.J.M.F. reports speaker fees from Gilead and Roche; serves on advisory boards for Gilead, Juno, Novartis, PletixaPharm, and Roche; and receives research grants from ADC Therapeutics, Bayer HealthCare Pharmaceuticals, BeiGene, BMS, Genmab, Gilead, Hutchison Medipharma, Incyte, Janssen Research & Development, MEI Pharma, Novartis, PletixaPharm, Pharmacyclics, Protherics PLC, Roche, and Takeda. S.H., X.L., H.Y., J.P., W.N., W.Z., and H.Z. are employees of and own stock in BeiGene, Inc. P.L.Z. reports consultancy roles for MSD, Eusapharma, and Novartis; serves on speakers bureaus for Celltrion, Gilead, Janssen-Cilag, BMS, Servier, MSD, TG Therapeutics, Takeda, Roche, Eusapharma, Kyowa Kirin, Novartis, Incyte, and BeiGene; and has served on advisory boards for Secura Bio, Celltrion, Gilead, Janssen-Cilag, BMS, Servier, Sandoz, MSD, TG Therapeutics, Takeda, Roche, Eusapharma, Kyowa Kirin, Novartis, ADC Therapeutics, Incyte, and BeiGene. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Kaplan-Meier plots of PFS per the investigator assessment. (A) Cohort 1 (ENKTL); (B) cohort 2 (PTCL-NOS, AITL, and ALCL); (C) cohort 2a (PTCL-NOS); (D) cohort 2b (AITL); (E) cohort 2c (ALCL); and (F) cohort 3 (MF or SS). CIs were calculated using a generalized Brookmeyer and Crowley method.
Figure 2.
Figure 2.
Kaplan-Meier plots of OS. (A) Cohort 1 (ENKTL); (B) cohort 2 (PTCL-NOS, AITL, and ALCL); (C) cohort 2a (PTCL-NOS); (D) cohort 2b (AITL); (E) cohort 2c (ALCL); and (F) cohort 3 (MF or SS). CIs were calculated using a generalized Brookmeyer and Crowley method.
Figure 3.
Figure 3.
Duration of treatment and TTR. (A) Cohort 1 (ENKTL); (B) cohort 2a (PTCL-NOS); (C) cohort 2b (AITL); (D) cohort 2c (ALCL); and (E) cohort 3 (MF or SS). Each lane represents 1 patient. PD, progressive disease.
See this image and copyright information in PMC

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