Spectrum announces data from clinical study of FOLOTYN plus Romidepsin
Spectrum Pharmaceuticals announced the presentation of data from a clinical study of FOLOTYN plus Romidepsin in patients with relapsed or refractory Peripheral T-Cell Lymphoma in an oral presentation session which was presented at the 14th International Conference on Malignant Lymphoma meeting in Lugano, Switzerland. Results of the Phase I Study of FOLOTYN plus Romidepsin reveals marked activity in patients with relapsed or refractory peripheral T-Cell Lymphoma. 29 patients were enrolled and evaluable for toxicity. 23 patients were evaluable for response. The ORR in the total, non-PTCL and PTCL populations was 57%, 33%, and 71%, respectively. Of the PTCL 10/14 achieved a response with a CR= 4/14, PR=6/14, and 1 patient had stable disease. The mean DOR in PTCL population was 7.49 m, PFS of 5.9 m, and OS 10.8 m in this heavily pretreated patient population. Median age was 54 y and 62% were male. The median number of prior therapies was 3. Histologies included HL/other, B-cell, and T-cell. There were 5 DLTs in cohort 3 over both schedules consisting of 3 Grade 4 thrombocytopenias, 1 Grade 4 pancytopenia, and 1 Grade 4 neutropenia all attributed to romidepsin. There were 3 DLTs in cohort 4A consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. The D1, 15 Q28D schedule had no mucositis and resulted in no DLTs at all dose levels. The Grade 3/4 toxicities reported in greater than5% of patients were: anemia, thrombocytopenia, febrile neutropenia, oral mucositis, hyponatremia, pneumonia, neutropenia, and sepsis. Results outlined in the presentation conclude that the combination of FOLOTYN and romidepsin given on the D1, 15 Q28D schedule has an acceptable safety profile. These data support the lineage specific activity of the FOLOTYN and romidepsin combination with a 71% ORR in PTCL. A multicenter Phase II study of FOLOTYN and romidepsin is now enrolling for PTCL.