Safety and efficacy of pralatrexate in patients with relapsed or refractory peripheral t-cell lymphoma from China

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Lymphomas
Presenter Yuqin Song
Citation Annals of Oncology (2018) 29 (suppl_9): ix87-ix93. 10.1093/annonc/mdy437
Authors Y. Song1, X. Hong2, H. Huang3, B. Bai3, H. Zhang4, X. Ke5, Y. Shi6, J. Zhu7, G. Lu8, S. Liebscher9, C. Cai8
  • 1Beijing Cancer Hospital, Beijing Cancer Hospital, 100142 - Beijing/CN
  • 2Internal Medicine Oncology, Fudan University Shanghai Cancer Center, Shanghai/CN
  • 3Cancer Center, Sun Yat-sen University, Guangzhou/CN
  • 4Cancer Institute & Hospital, Tianjin Medical University, Tianjin/CN
  • 5Internal Medicine Oncology, Peking University Third Hospital, Beijing/CN
  • 6Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100000 - Beijing/CN
  • 7Beijing Cancer Hospital, Beijing Cancer Hospital, Beijing/CN
  • 8Medical, Mundipharma (China) Pharmaceutical Co., Ltd, Beijing/CN
  • 9Data Management & Statistics, Mundipharma Research GmbH, Limburg/DE



Pralatrexate (Folotyn®), a folate analogue metabolic inhibitor, was the first drug approved to treat relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). As few patients in the pivotal PROPEL trial were of Asian ethnicity, we investigated the efficacy and safety of pralatrexate in Chinese patients.


In this single-arm, open-label, multicentre study, patients with R/R PTCL received pralatrexate IV 30 mg/m2/wk for 6 weeks in 7-week cycles for ≤24 months (with concurrent vitamin B12/folate). The primary endpoint was objective response rate (ORR) per central review. The null hypothesis under test was ORR <15%.


Seventy-one patients received ≥1 dose of study medication; all were Asian, mean (SD) age was 54.5 (12.5) years, and 66% were male. Mean (SD) duration of PTCL was 2.2 (2.4) years and median (range) number of prior treatments was 2 (1, 14). A median (range) of 11 (1, 73) pralatrexate infusions were administered. ORR (95% CI) was 52% (40%, 64%) (p < 0.001), including 6 patients (9%) with complete response (CR), 8 (11%) with unconfirmed CR and 23 (32%) with partial response. Median (95% CI) duration of response was 8.7 (3.3, 14.1) months and first response was observed in Cycle 1 for most (84%) patients. Prespecified subgroup analyses revealed responses to pralatrexate irrespective of patients’ age, gender, disease subtype, and response to prior treatment. Median (95% CI) progression-free survival and overall survival were 4.8 (3.1, 8.1) months and 18.0 (10.4, NA) months, respectively. Almost all patients experienced treatment-emergent adverse events (TEAE; n = 70), the most frequent being stomatitis (66%), anaemia (49%) and ALT increase (41%). Serious TEAEs with incidence ≥10% were decreased platelet count (14%) and lung infection (10%). Three patients died due to treatment-related AEs (febrile neutropenia, lung infection, septic shock).


Pralatrexate induced rapid and durable responses in Chinese patients with R/R PTCL, with similar/favourable efficacy to previous reports in Western studies. No new safety concerns were identified in this study population.

Editorial acknowledgement

Siân Marshall (Siantifix Ltd).

Clinical trial identification


Legal entity responsible for the study

Mundipharma (China) Pharmaceutical Co., Ltd.


Mundipharma (China) Pharmaceutical Co., Ltd.


G. Lu, C. Cai: Employee of the sponsor, Mundipharma (China) Pharmaceutical Co., Ltd. S. Liebscher: Employee: Mundipharma Research GmbH. All other authors have declared no conflicts of interest.