Pooled Analysis of Pralatrexate Single-Agent Studies in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma.

Patients with relapsed or refractory (r/r) mature NK and T-cell lymphoma (MTCL) have limited treatment options. To evaluate pralatrexate's performance and factors influencing its safety and efficacy in r/r PTCL, we performed a pooled analysis of data from four similarly designed, regulatory-mandated prospective clinical trials. Of 221 patients (59 years median age; 67.0% male) in the study population, 48.9% had peripheral T-cell lymphoma 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 2.56 months (range, 0.03-24.18) and had a 40.7% objective response rate with a median 9.1-month duration of response, 4.6-month progression-free survival, and 16.3-month overall survival. The most common treatment-related all grade adverse events were stomatitis, thrombocytopenia, white blood cell count decreased, pyrexia, and vomiting. Subgroup exploratory analyses suggest improved efficacy with 1 prior line of chemotherapy versus 2 or ≥ 4 prior lines; PTCL NOS or ALCL versus transformed mycosis fungoides; chemotherapy and transplant before pralatrexate versus chemotherapy alone or chemotherapy with other non-transplant 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.