Leucovorin Mitigates Mucositis in Patients Treated with FOLOTYN.
Dec 3, 2018 Spectrum Pharmaceuticals Announces Positive Results from Phase 2 Trial Evaluating Use of Oral Leucovorin to Potentially Mitigate Mucositis in Patients Treated with FOLOTYN® (pralatrexate) PDF Version • 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) HENDERSON, Nev.--(BUSINESS WIRE)--Dec. 3, 2018-- Spectrum Pharmaceuticals, Inc.(NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced results from a prospective Phase 2 single-arm, open-label, multicenter clinical trial studying the management of oral mucositis with the use of oral leucovorin (d,l-folinic acid) as adjunct to FOLOTYN® (pralatrexate) in patients with hematological malignancies, including PTCL and CTCL. These new data were highlighted in a poster presentation 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 medicine, hematology, University of Washington School of Medicine, and hematologist, Seattle Cancer Care Alliance. “We are excited about how significantly leucovorin was able to reduce the rate of mucositis in patients and believe this study established the foundation for the potential use of leucovorin as a preventive regimen for FOLOTYN patients.” “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 Francois Lebel, MD, Chief Medical Officer, Spectrum Pharmaceuticals. “This is the first prospective study to suggest that leucovorin may prevent or reduce oral mucositis. These are welcome findings that merit further studies of leucovorin as an adjunct to FOLOTYN so we can one day provide definitive guidance to physicians to help reduce concerns of FOLOTYN treatment delay or discomfort due to oral mucositis.” http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-announces-positive-results-phase-2
Hey, when stating it this way
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
comes across much better and to the point as opposed to the abstract released a month ago
Conclusions: Overall safety profile of the study treatment was consistent with pivotal trial of Pralatrexate in R/R PTCL. Leucovorin as adjunctive treatment resulted in a significant reduction in rates of both ≥Grade 2, and ≥Grade 3 mucositis and should be considered in patients treated with Pralatrexate.
Also note they tested patients that had CTCL. I guess when nothing else is working in CTCL, they'll use Folotyn which can have positive results in some patients.
Anyhows, this trial was a strong topic of discussion when it was initiated years ago since one problem with Folotyn effectiveness was patients stopping treatment early due to AEs and if they stop treatment early you get less revenue. This data shows they can stay on treatment and revenue will increase correspondingly. It will be interesting to see the trend in Folotyn use/revenue in the next year or so (i.e if you get $8m in revenue now will it be $12m in the future?). I would think they'll work on getting a sNDA for a label change on use, but even if don't I'm sure any onc doc who uses Folotyn will be adding leucovorin. Very positive for Folotyn.
