POTELIGEO achieved greater ORR and longer DoR vs vorinostat1,2

Secondary endpoint: ORRa (P<0.001)

Secondary endpoint: POTELIGEO demonstrated 5x greater median time to overall response vs vorinostat

Secondary endpoint: DoR (median)

Secondary endpoint: POTELIGEO demonstrated 54% longer duration of response vs vorinostat
  • aOverall response was defined as ≥50% improvement in skin + ≥50% improvement in at least 1 other involved compartment + no progression of disease in any compartment.3,4
  • bTime to response 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.
  • In the first year of treatment, overall response was assessed at the end of Cycle 1 and every 8 weeks thereafter (Cycles 3, 5, 7, etc). After the first year, overall response was assessed every 16 weeks (Cycles 17, 21, 25, etc). Responses from baseline had to be demonstrated at 2 consecutive assessments for patient to be considered a responder.3
  • Median dose intensity was >95% for both treatment arms.3
  • CR=complete response; PR=partial response

See the latest blood response data from the MAVORIC post hoc analysis

Watch the POTELIGEO Efficacy in Blood video

In a post hoc analysis, POTELIGEO achieved significantly greater overall response rate by blood classification vs vorinostat5,c

Investigator-assessed ORR by blood classification

POTELIGEO demonstrated investigator-assessed overall response 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

cORR 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)1,3,6

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 CLASSIFICATION5

  • (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 characteristics1,2
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 criteria4
  • 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

POTELIGEO has a consistent safety profile with up to 5 years of data6

View safety profile
References:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, NJ USA.
  2. Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.
  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. 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.
  5. 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.
  6. 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].

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.