POTELIGEO achieved greater ORR and longer DoR vs vorinostat1

Secondary endpoint: ORR (P<0.001)

poteligeo overall response rate (ORR) vs. vorinostat

Secondary endpoint: DoR (median)

poteligeo duration of response (DOR) vs. vorinostat

Overall response was defined as2,3

≥50% improvement in skin

+

≥50% improvement in at least 1 other involved compartment

+

No progression of disease in any compartment

Median time to overall response4,a: (post hoc analysis)

poteligeo median time to overall response is 3.3 months
  • aTime 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.2
  • Median dose intensity was >95% for both treatment arms.2
  • 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

Investigator-assessed ORR by blood classificationb

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
    or 1 of the following:

    • CD4:CD8 ratio ≥10,
    • 40% CD4+CD7- cells, or
    • ≥30% CD4+CD26- cells

bORR 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 and Sézary Syndrome1,2,6

372 patients with Mycosis Fungoides (MF) and Sézary Syndrome (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).

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

The MAVORIC trial included a broad range of patients1,2,4

CTCL subtype: 56% MF and 44% SS
CTCL subtype: 56% MF and 44% SS

BLOOD CLASSIFICATION3,5

  • (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
    or 1 of the following:

    • CD4:CD8 ratio ≥10,
    • 40% CD4+CD7- cells, or
    • ≥30% CD4+CD26- cells
Patient characteristics1,4
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)
Prior systemic therapies
Median, 3 Min, 0 Max, 18
Key exclusion criteria3
  • 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., Princeton, NJ USA.
  2. 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.
  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. Supplementary appendix published online August 9, 2018. doi.org/10.1016/S1470-2045(18)30379-6
  4. Data on file. Kyowa Kirin Inc., Princeton, NJ USA.
  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;35(11):2225-2238.
  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.

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.