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New Treatment Option Extends CTCL Progression Free Survival

by U.S. Medicine

January 4, 2018

STANFORD, CA — Patients with cutaneous T-cell lymphoma (CTCL) might have a promising new treatment option, according to a study presented at a recent conference.

In a presentation at the 2017 American Society of Hematology Annual Meeting in Atlanta, an international team of researchers outlined results of a phase III study that found mogamulizumab therapy doubled progression free survival in patients with previously treated CTCL compared to the current standard of care, vorinostat.1

Mogamulizumab is a monoclonal antibody directed against chemokine receptor 4 (CCR4), which is overexpressed on malignant T-cells.

“Cutaneous T- cell lymphoma (CTCL) is a rare form of non-Hodgkin lymphoma,” wrote the Stanford University-led study team, which included participation from the Salt Lake City VAMC. “Patients with CTCL suffer reduced quality of life from intractable itching and recurrent infections. Advanced stages have a poor prognosis.”

In a Phase I-II study in CTCL, mogamulizumab demonstrated a tolerable safety profile with a 37% overall response rate (ORR), and, based on those results, MAVORIC, an open-label, multinational, randomized, Phase III study, was launched to compare the product to vorinostat in previously treated CTCL.

The study, which researchers tout the study as the largest randomized trial and the first pivotal trial to use progression-free survival (PFS) as a primary endpoint in CTCL, enrolled 372 patients with mycosis fungoides (MF) or Sezary syndrome (SS) who had failed at least one systemic therapy. Researchers randomized patients to receive either mogamulizumab or vorinostat; patients in the vorinostat arm could crossover to the investigational arm upon progression or intolerable toxicity.

Participants were randomized 1:1 to mogamulizumab 1.0 mg/kg (weekly for the first four-week cycle and then every two weeks or vorinostat, 400 mg daily. The primary endpoint was defined as progression free survival using a global composite response based on skin, blood, nodes and viscera.

Overall, investigators reported that mogamulizumab improved progression free survival by 47%. Patients receiving mogamulizumab had median progression free survival of 7.7 months compared to 3.1 for patients receiving vorinostat. Independent reviewers found a 36% increase in progression free survival, 6.7 months for mogamulizumab vs 3.8 months for vorinostat.

Mogamulizumab had a much higher objective response rate as well at 28% vs 4.8 for vorinostat. Patients who switched from the vorinostat arm to the mogamulizumab arm had a 30.1% objective response rate.

Patients also reported much greater reduction in symptoms and improvement in functional status on mogamulizumab than vorinostat throughout treatment.

Treatment-emergency adverse events associated with mogamulizumab included infusion-related reactions (33.2%) and skin eruptions (23.9%), neither of which occurred in more than 1% of patients receiving vorinostat. Vorinostat was associated with much higher rates of diarrhea, thrombocytopenia, dysgeusia and elevated blood creatinine, all of which occurred in more than 28% of patients.

Study authors concluded that their study supports mogamulizumab as “a valuable new therapeutic option in patients with CTCL.”

1Kim HK, Bagot M, Pinter-Brown L, Rook AH, et. al. Anti-CCR4 Monoclonal Antibody, Mogamulizumab, Demonstrates Significant Improvement in PFS Compared to Vorinostat in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): Results from the Phase III MAVORIC Study. American Society of Hematology 59th Annual Meeting and Exposition. 2017 Dec 9-12. Atlanta, Georgia.


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