POTELIGEO was studied in the largest randomized trial of systemic CTCL therapy

Phase 3 study design1

Visual of MAVORIC phase 3 study design

Study description

  • MAVORIC, the basis for FDA approval, was a randomized open-label, multinational, phase 3 trial
  • MAVORIC was the first CTCL trial to use progression-free survival (PFS) as its primary endpoint
  • The active comparator was vorinostat, an FDA-approved CTCL treatment
  • Patients with previously treated MF or SS were randomized to either POTELIGEO (1 mg/kg intravenous injection administered once weekly for the first 5 doses and once every 2 weeks thereafter) or vorinostat (400 mg PO daily)
  • Primary endpoint was PFS assessed by the investigator
  • Secondary endpoints included overall response rate (ORR) and duration of response (DOR); exploratory endpoints included DOR by compartment and response by disease subtype
  • Patients were included in the study regardless of their CCR4 status
  • Patients were excluded from the study if they had active autoimmune diseases, central nervous system metastasis, medical conditions that required systemic corticosteroids or other immunosuppressive medication, or an active infection requiring therapy
  • Vorinostat-treated patients with disease progression or unacceptable toxicities were permitted to cross over to POTELIGEO

MAVORIC study patient disposition1,2

Table of select patient baseline characteristics from MAVORIC
Visual of patient MAVORIC baseline characteristics; percentage of stages and percentages of disease subtype

CCR4 status1

  • 75% (n=140) of POTELIGEO patients were tested for CCR4 status
  • All had CCR4 detected on ≥1% of lymphocytes on skin biopsy
  • 96% (n=134) had CCR4 detected on ≥10% of lymphocytes
  • CCR4 expression status was similar in the vorinostat arm
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

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Warnings and Precautions

  • Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
  • Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.
  • Infections: Monitor patients for signs and symptoms of infection and treat promptly.
  • Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
  • Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

  • The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
  • You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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POTELIGEO is a registered trademark of
Kyowa Hakko Kirin Co., Ltd.
© 2018 Kyowa Kirin, Inc. All rights reserved.
PRC-MOG-0129 August 2018