POTELIGEO more than doubled median PFS vs vorinostat (P<0.001)1

Primary endpoint: PFS

POTELIGEO demonstrated progression-free survival of 7.6 months compared to 3.1 months with vorinostat

In a post hoc analysis, POTELIGEO demonstrated greater PFS across all blood classifications vs vorinostat1,2,a

Primary endpoint: PFS

POTELIGEO demonstrated progression-free survival greater than vorinostat across all blood classifications

BLOOD CLASSIFICATION

  • <15% CD4+CD26- or CD4+CD7- cells by flow cytometry

  • ≥15% CD4+CD26- or CD4+CD7- cells by flow cytometry
  • ≥1000/μL Sézary cells with positive clone, CD4:CD8 ratio ≥10, 40% CD4+CD7- cells, or ≥30% CD4+CD26- cells

aPFS by blood classification was measured based on a post hoc analysis; a finding from the post hoc analysis cannot be used to demonstrate differences between treatments and may not be applicable to all patients initiating POTELIGEO.

POTELIGEO was evaluated in the largest randomized, open-label, phase 3 trial of a systemic therapy for patients with mycosis fungoides (MF) and Sézary syndrome (SS)1,3,4

372 patients with MF and SS were evaluated across stage IB-IV for progression-free survival (PFS) as well as overall response rate (ORR) and duration of response (DoR) in multiple disease compartments (skin, blood, lymph nodes, viscera) for up to 5 years.

MAVORIC

Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL

Flowchart describing the design of an open-label phase 3 trial in which POTELIGEO was evaluated

POTELIGEO was studied in a broad range of patients1

CTCL subtype: 56% MF and 44% SS

BLOOD CLASSIFICATION2

  • (n=64)
  • <15% CD4+CD26- or CD4+CD7- cells by flow cytometry
  • (n=31)
  • ≥15% CD4+CD26- or CD4+CD7- cells by flow cytometry
  • (n=91)
  • ≥1000/μL Sézary cells with positive clone, CD4:CD8 ratio ≥10, 40% CD4+CD7- cells, or ≥30% CD4+CD26-cells
Patient characteristics1,5
Stage
IB-IIA, 23% IIB, 15% III, 10% IV, 52%
Age (years)
Median, 64 Min, 25 Max, 101
Sex
Males, 58% Females, 42%
Race
White, 70% African American, 13% Asian, 7% Other, 10% (Not reported)
Key exclusion criteria6
  • Large cell transformation at study entry
  • Active autoimmune diseases
  • CNS metastasis
  • Active infection requiring therapy
  • Medical conditions requiring systemic corticosteroids or other immunosuppressive medication

CNS=central nervous system; CTCL=cutaneous T-cell lymphoma; PO=by mouth; R/R=relapsed or refractory

POTELLIGENT® technology

Explore POTELLIGENT technology, an innovative approach designed to enhance antibody-dependent cellular cytotoxicity.

Overall response rate (ORR) and duration of response (DoR) were secondary endpoints in the MAVORIC trial1,5

See efficacy data
References:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, NJ USA.
  2. Cowan R, Scarisbrick JJ, Zinzani PL, et al. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. J Eur Acad Dermatol Venereol. 2021;doi:10.1111/jdv.17523.
  3. Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.
  4. Kim Y, Bagot M, Zinzani PL, et al. Safety of mogamulizumab in mycosis fungoides and Sézary syndrome: final results from the phase 3 MAVORIC study. Blood. 2019;134(suppl):5300[abstract].
  5. Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.
  6. Supplement to: Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion 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

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.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

Important Safety Information

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion 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.

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.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.