FDA Approves Poteligeo for Two Types of Cutaneous T-cell Lymphoma

FDA Approves Poteligeo for Two Types of Cutaneous T-cell Lymphoma
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Poteligeo approved by FDA

The U.S. Food and Drug Administration (FDA) recently approved Poteligeo (mogamulizumab-kpkc) for adults with relapsed or hard-to-treat mycosis fungoides (MF) or Sézary syndrome (SS) — two types of cutaneous T-cell lymphoma— who had failed at least one prior systemic therapy. This marks the first FDA-approved treatment option for SS.

The agency’s decision was based on a Phase 3 trial that showed Poteligeo significantly slowed disease progression in MF and SS compared with the chemotherapy medication Zolinza (vorinostat).

The study, “Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomized, controlled phase 3 trial,” was published in The Lancet Oncology. The work was sponsored by the therapy’s developer, Kyowa Kirin.

Mycosis fungoides and Sézary syndrome are the most common cutaneous T-cell lymphomas (CTCL), a diverse group of tumors that primarily affect the skin. Treatment is usually to relieve symptoms and improve quality of life.

Poteligeo, administered by infusion, is an inhibitor of CCR4, a molecule used by lymphoma and leukemia cells to travel from the bloodstream into the skin. By blocking this movement, Poteligeo prevents the development of skin lesions.

In the randomized MAVORIC Phase 3 trial (NCT01728805), researchers compared the progression-free survival of adult MF and SS patients given Poteligeo versus Zolinza. Progression-free survival (PFS) was defined as the time elapsed between the start of treatment and cancer progression or death from any cause, whichever came first, assessed up to 36 months.

This was the first study to use PFS as a primary endpoint and the largest randomized trial to evaluate systemic therapies in CTCL.

“Progression-free survival captures the duration of disease control with treatment based on the composite response assessment of each disease compartment, skin, blood, lymph nodes, and viscera, and may more broadly reflect the overall impact of new therapies,” Youn Kim, MD, the study’s lead investigator, said in a press release.

Researchers studied 370 patients across 61 centers in 11 countries. Participants were randomly assigned either Poteligeo or Zolinza.

Zolinza is indicated for the treatment of cutaneous manifestations in CTCL patients with progressive, persistent, or recurrent disease or following two systemic therapies. It inhibits an enzyme called histone deacetylase (HDAC), which is involved in cellular division and is abundant in cancer cells. Inhibition of HDAC activity causes cell cycle arrest and cell death.

Results showed a significant benefit with Poteligeo. Those receiving it lived on average 7.7 months without their cancer growing; those taking Zolinza lived with no tumor growth for 3.1 months.

The overall response rate, time to response, and duration of response also favored treatment with Poteligeo. Approximately 35% of patients in the Poteligeo group achieved the best overall response and 44% had a minimum 50% improvement in skin response.

For those assigned Zolinza, the best overall response was seen in 6% of patients; 22% had at least a 50% improvement in skin lesions.

Patient-reported outcomes measuring skin symptoms, functional status, and well-being also significantly favored Poteligeo. A comprehensive report of patient-reported outcomes is planned for future publication, researchers said.

Taking previous trials into consideration, Poteligeo revealed no new safety concerns. Infusion-related reactions (34%) and skin eruptions (24%) were the most common adverse effects. Diarrhea, nausea, low platelet count, impaired sense of taste, and increased blood creatinine occurred more frequently in the Zolinza group.

“Mycosis fungoides and Sézary syndrome can be debilitating for patients and complex to treat and manage for healthcare professionals,” said Jeffrey S. Humphrey, MD, chief medical officer and president of Kyowa Kirin. “We are encouraged that these findings underscore the viability of mogamulizumab as a new treatment option for patients living with MF or SS.”

Kim, a professor of dermatology/medicine and director of the Multidisciplinary Cutaneous Lymphoma Program at Stanford University School of Medicine and Stanford Cancer Institute, said that “progression-free survival is more informative about the duration of overall clinical benefit for patients with a chronic course as in CTCL compared to using the overall response rate as a primary endpoint.”

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