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

Abstract

Background

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.

Methods

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%.

Results

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).

Conclusions

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

FOT12-CN-301.

Legal entity responsible for the study

Mundipharma (China) Pharmaceutical Co., Ltd.

Funding

Mundipharma (China) Pharmaceutical Co., Ltd.

Disclosure

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.