On December 13, 2017 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported two oral presentations of data on FOLOTYN and research progress for the treatment of Peripheral T-Cell Lymphoma (PTCL) at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Spectrum Pharmaceuticals, DEC 13, 2017, View Source [SID1234522641]).
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Abstract #818: Pralatrexate in Combination with Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Previously Untreated Patients with Peripheral T-Cell Lymphoma (PTCL): A Phase 1 Dose-Escalation Study
In this study presented by Dr. Andrei Shustov from Division of Hematology, University of Washington, a total of 31 patients have been enrolled (19 in Part 1; 12 in Part 2). MTD was not reached and pralatrexate dose of 30 mg/m2 in combination with CHOP was selected for Part 2 of the study as predefined by the protocol. The majority of patients were male, white, with the median age of 57.7 years (range, 18-78) at the time of enrollment. PTCL diagnoses included: anaplastic large cell lymphoma, anaplastic lymphomakinase-negative (ALCL, ALK-, n=5), peripheral T-cell lymphoma, not-otherwise specified (PTCL-NOS, n=18), and angioimmunoblastic T-cell lymphoma (AITL, n=5). Fol-CHOP was generally well tolerated with median RDI of 98%. Grade 3/4 adverse events included anemia (23%), neutropenia (23%), fatigue (13%), and vomiting (13%), as well as febrile neutropenia, nausea, and mucositis each in 10% of the patients. SAEs were observed in 13 patients, treatment related SAEs were anemia, febrile neutropenia, dehydration, mucositis, and nausea. Six patients withdrew from study before the completion of the follow-up, and dose reduction or dose delay occurred in four patients. In the 29 patients evaluable for response, the investigator assessed objective response (OR) and complete response (CR) rates were 90% and 66%, respectively.
Abstract #342: The Role of Upfront Hematopoietic Stem Cell Transplantation (HSCT) in Peripheral T-Cell Lymphoma (PTCL) Patients in Complete Remission (CR) with a Special Focus on Nodal PTCL: Report from the Comprehensive Oncology Measures for Peripheral T-Cell Lymphoma Treatment (COMPLETE), a Prospective Multicenter Cohort Study
In this study, presented by Dr. Steven Park from Levine Cancer Institute, a total of 499 PTCL patients were enrolled in COMPLETE over 4 years. Two hundred thirteen patients achieved a CR following frontline therapy and had the required locked records for the analysis with a median follow-up of 2.9 years (Range 1.9-4.0). One hundred forty nine (70%) of these received induction therapy without HSCT consolidation and 64 (30%) underwent either autologous (n = 49) or allogeneic (n = 15) HSCT. This is the first report from the largest prospective PTCL database in the U.S. to date to examine the role of HSCT in PTCL patients who are in first CR. Our data demonstrate potential survival advantages of upfront HSCT in patients with nodal PTCL who achieve CR. However, the results should be interpreted with caution given a relatively short median follow up as well as the non-randomized study design. The role of HSCT among various groups of PTCL patients in first CR should further be evaluated in randomized controlled trials.
"We are honored that two oral presentations and multiple abstracts were presented at the 59th ASH (Free ASH Whitepaper) Meeting," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "FOLOTYN was the first drug approved for the treatment of relapsed or refractory PTCL. PTCL is an aggressive disease with a poor prognosis and we are excited that FOLOTYN has the potential to improve outcome for PTCL patients."