On June 19, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the presentation of data from a clinical study of FOLOTYN plus Romidepsin in patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) in an oral presentation session which was presented at the 14th International Conference on Malignant Lymphoma (ICML) meeting in Lugano, Switzerland (Press release, Spectrum Pharmaceuticals, JUN 19, 2017, View Source [SID1234519612]). Schedule your 30 min Free 1stOncology Demo! "Promising doublets may create new treatment platforms and change the paradigms of care for T-cell lymphoma," concluded Dr. Jennifer E. Amengual of the Columbia University Medical Center Herbert Irving Comprehensive Cancer Center.
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"We are excited about the encouraging data presented at the ICML meeting," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "These results show that the combination of FOLOTYN, an antifolate, and an HDAC inhibitor such as romidepsin could be highly effective in the treatment of PTCL patients. FOLOTYN was the first drug approved for the treatment of relapsed or refractory PTCL and it continues to be used in pioneering research for this aggressive disease with poor prognosis. We are encouraged that FOLOTYN has the potential to further improve outcome for PTCL patients."
Abstract #076: Results of the Phase I Study of FOLOTYN (pralatrexate injection) plus Romidepsin reveals marked activity in patients with relapsed or refractory (R/R) peripheral T-Cell Lymphoma (PTCL)
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 (29%), PR=6/14 (43%), and 1 patient had stable disease. The mean DOR in PTCL population (N=10) was 7.49 m (1.5 – 30.2+), PFS of 5.9 m (0.3 – 33.2+), and OS 10.8 m in this heavily pretreated patient population.
Median age was 54 y (23-73) and 62% were male. The median number of prior therapies was 3 (1-16). Histologies included HL/other (N=4), B-cell (N=7), and T-cell (N=18). There were 5 DLTs in cohort 3 (FOLOTYN 15 mg/m2 & romidepsin 14 mg/m2) 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 (FOLOTYN 20mg/m2 & romidepsin 12mg/m2given D1, 8 Q21D) 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 > 5% of patients were: anemia (29%), thrombocytopenia (28%), febrile neutropenia (14%), oral mucositis (14%), hyponatremia (7%), pneumonia (6%), neutropenia (6%), and sepsis (7%).
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.