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. 2024 Jun 11;8(11):2601-2611.
doi: 10.1182/bloodadvances.2023010441.

Pooled analysis of pralatrexate single-agent studies in patients with relapsed/refractory peripheral T-cell lymphoma

Owen A O'Connor  1 , Bor-Sheng Ko  2   3 , Ming-Chung Wang  4 , Dai Maruyama  5   6 , Yuqin Song  7 , Ee-Min Yeoh  8 , Nick Manamley  9 , Kensei Tobinai  5
Affiliations

Pooled analysis of pralatrexate single-agent studies in patients with relapsed/refractory peripheral T-cell lymphoma

Owen A O'Connor et al. Blood Adv. .

Abstract

Patients with relapsed or refractory (R/R) mature natural killer cell and T-cell lymphoma have limited treatment options. To evaluate pralatrexate's performance and factors influencing its safety and efficacy in R/R peripheral T-cell lymphoma (PTCL), we performed a pooled analysis of data from 4 similarly designed, regulatory-mandated prospective clinical trials. Of 221 patients (median age, 59 years; 67.0% male) in the study population, 48.9% had PTCL not otherwise specified (PTCL-NOS), 21.3% angioimmunoblastic T-cell lymphoma, and 11.8% ALK-negative anaplastic large cell lymphoma (ALCL). Patients received pralatrexate for a median of 2.56 months (range, 0.03-24.18) and had a 40.7% objective response rate with a median duration of response of 9.1 months, progression-free survival 4.6 months, and overall survival 16.3 months. The most common treatment-related all-grade adverse events were stomatitis, thrombocytopenia, white blood cell count decrease, pyrexia, and vomiting. Subgroup exploratory analyses suggest improved efficacy with 1 prior line of chemotherapy vs 2 or ≥4 prior lines; PTCL-NOS or ALCL vs transformed mycosis fungoides; chemotherapy and transplant before pralatrexate vs chemotherapy alone or chemotherapy with other nontransplant treatments. In conclusion, these pooled analysis results further support using pralatrexate in patients with R/R PTCL. Prospective studies are needed to confirm the findings of subgroups analyses.

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Conflict of interest statement

Conflict-of-interest disclosure: O.A.O. has received research support from Merck and Astex; and is on the board of directors for Kymera, Myeloid Therapeutics, and Dren Pharmaceuticals, for which he receives an honorarium and is an equity holder. D.M. receives research funding from Astellas Pharma, Celgene, Novartis, Chugai, Ono, Takeda, Janssen, Sanofi, MSD, Otsuka, Eisai, AbbVie, Amgen, and BMS; and receives honoraria from Celgene, Chugai, Ono, Takeda, Janssen, Sanofi, MSD, Eisai, AbbVie, BMS, Mundipharma, Kyowa Kirin, Zenyaku, AstraZeneca, Nippon, and SymBio. E.-M.Y. is employed by Mundipharma Singapore Holdings Pte Ltd. N.M. is employed by Mundipharma Research Limited. K.T. receives honoraria from Celgene, Chugai, Eisai, Daiichi Sankyo, HUYA Bioscience International, Kyowa Kirin, Mundipharma, Ono Pharmaceutical, Solasia Pharma, Takeda, Yakult, and ZenyakuKogyo; and consults for Celgene, Daiichi Sankyo, HUYA Bioscience International, Mundipharma, Ono Pharmaceutical, Takeda, and Zenyaku Kogyo. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Kaplan-Meier plots of PFS (A) and OS (B).
Figure 2.
Figure 2.
Response in patients with SCT after pralatrexate treatment. AITL, angioimmunoblastic T-cell lymphoma; ENKT, extranodal NK/T-cell lymphoma; PTCL-NOS, peripheral T-cell lymphoma, not otherwise specified; ALCL, analplastic large T-cell lymphoma.
Figure 3.
Figure 3.
Forest plots for subgroup analyses of ORR (A), PFS (B), and OS (C).
Figure 3.
Figure 3.
Forest plots for subgroup analyses of ORR (A), PFS (B), and OS (C).
See this image and copyright information in PMC

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