Efficacy and safety of single-agent pralatrexate for treatment of angioimmunoblastic T-cell lymphoma after failure of first line therapy: a pooled analysis

Abstract

Angioimmunoblastic T-cell lymphoma (AITL) is a histological subtype of peripheral T-cell lymphoma associated with a poor prognosis. This post-hoc pooled analysis aims to provide insight about the efficacy of pralatrexate monotherapy in a subset of twenty-nine patients with relapsed or refractory (r/r) AITL drawn from two prospective registration trials completed in China and Japan. After a median of two prior lines of therapy, an overall response rate of 52% (15/29 patients; 95% CI 0.34, 0.70) was demonstrated. The estimated median duration of response, progression free survival (PFS) and overall survival (OS) were 6.4 months (196 days), 5.0 months (151 days), and 18.0 months (548 days), respectively. Grades 1–3 mucositis was observed in twenty-three patients (79.3%); and hemato-toxicity in twenty-six (89.7%) patients. Results of this analysis corroborate with data from two previously reported US retrospective cohorts, supporting the potential benefits of pralatrexate monotherapy in patients with r/r AITL.

Keywords:

• Angioimmunoblastic T-cell lymphoma
• pralatrexate
• relapsed/refractory
• peripheral T-cell lymphoma
• PTCL
• AITL

Acknowledgments

The authors would like to thank Tomoko Murase and Rieko Ichihara, of Mundipharma Japan for their assistance in statistical support for this manuscript. Medical writing support was provided by Phillips Gilmore Oncology Communications and CoCre8ed Consulting.

Disclosure statement

JZ: Nothing to disclose. EMY: Employee of Mundipharma. YM: Has received grants and honoraria from Takeda and Kyowa Hakko Kirin Co; and has also received honoraria from Chugai, Novartis, Otsuka, Astellas, AsahiKASEI, Sumitomo Dainippon, Mochida, Bristol-Myers Squibb, Pfizer, Nippon Shinyaku, Janssen, Celgene, Eisai, Mundipharma, and Meiji Seika. KT: Has received grants and personal fees from Mundipharma, Eisai, Takeda, Kyowa Hakko Kirin, Celgene, Chugai Pharma, and Ono Pharmaceutical; has also received personal fees from Zenyaku Kogyo, HUYA Bioscience International, Yakult, Daiichi Sankyo, Bristol-Myers Squibb, Meiji Seika Kaisha, Solasia Pharma, and Verastem; and has received grant support from Abbvie and Janssen.

Additional information

Funding

This study was funded by Mundipharma.