Spectrum Pharmaceuticals Announces Positive Results from Phase 2 Trial Evaluating Use of Oral Leucovorin to Potentially Mitigate Mucositis in Patients Treated with FOLOTYN® (pralatrexate)
- In practice, FOLOTYN use has caused Grade 2 or higher oral mucositis in more than half of patients, potentially impacting treatment of relapsed or refractory Peripheral T-cell Lymphoma (PTCL)
- This was the first prospective study to evaluate the effect of oral leucovorin in preventing or reducing FOLOTYN-related oral mucositis in patients with hematological malignancies, including PTCL and CTCL
- New data demonstrated FOLOTYN treatment with adjunct leucovorin has resulted in a significantly lower rate of ≥ Grade 2 oral mucositis (5.7%) as compared to historical data (52%); no patient reported ≥ Grade 3 oral mucositis
- No patient omitted, delayed or reduced FOLOTYN dose due to oral mucositis
Data appeared in a poster at the 60th Annual Meeting of the
American Society of Hematology(ASH)
Study results with a total of 35 patients demonstrated that use of leucovorin 25 mg tablets by oral administration for two days (a total of six doses [150 mg cumulative weekly dose]), initiated 24 hours after each FOLOTYN dose (30 mg/m2 IV administration, once weekly for six weeks in each cycle) reduced the rate of Grade 2 or greater mucositis significantly, to 5.7 percent (95% CI = 1 – 19%) from historic rate (52%) associated with FOLOTYN use. There were no reports of ≥ Grade 3 oral mucositis. Grade 1 oral mucositis was reported only in 4 (11%) patients. No patient omitted, delayed or reduced FOLOTYN dose due to oral mucositis with adjunct leucovorin therapy. The occurrence of mucositis, an impediment of FOLOTYN, has previously been reported at a rate of 52 percent at Grade 2 or higher in patients undergoing treatment with FOLOTYN in a registration study (PROPEL).1
“Mucositis is a frequent complication of FOLOTYN therapy, which can
cause painful inflammation of the digestive tract. It is often managed
by omitting, delaying, or reducing the dose of this medication in some
patients,” said Andrei R Shustov, MD, lead investigator, professor of
“While previous studies have established the use of FOLOTYN as an option
in relapsed or refractory PTCL patients, mucositis has been an issue
that could impact treatment and quality of life,” said
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by
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.
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 seven 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.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
1 O’Connor OA, Pro B, et al. Pralatrexate in patients with
relapsed or refractory peripheral T-cell lymphoma: results from the
pivotal PROPEL study. J
Spectrum Pharmaceuticals, Inc.
Vice President, Strategic Planning & Investor Relations