Spectrum Pharmaceuticals Highlights Results of a Combination Study of FOLOTYN® (pralatrexate injection) Plus Romidepsin Presented at the 14th International Conference on Malignant Lymphoma (14-ICML) Meeting
- The FOLOTYN (antifolate) and an HDAC inhibitor (romidepsin) combination was shown to achieve a 71% overall response rate (ORR) among PTCL patients.
"Promising doublets may create new treatment platforms and change the
paradigms of care for T-cell lymphoma," concluded Dr.
"We are excited about the encouraging data presented at the ICML
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.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI
International, and Southern Research Institute, and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN for use as
a single agent for the treatment of patients with relapsed or refractory
PTCL. This indication is based on overall response rate. Clinical
benefit such as improvement in progression-free survival or overall
survival has not been demonstrated. FOLOTYN has been available to
patients in the
Important FOLOTYN® Safety Information
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
Mucositis may occur. If greater-than or equal-to Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are greater-than or equal-to Grade 3, omit or modify dose.
The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at www.FOLOTYN.com.
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