POTELIGEO achieved a higher response rate with a long duration of response (CR+PR) in blood1-3

Response rate (confirmed response)a-c (ad hoc analysis of secondary endpoint)

Secondary endpoint: POTELIGEO demonstrated 3x greater response rate (confirmed response) vs vorinostat

Duration of continued response (median)d (post hoc analysis)

Secondary endpoint: POTELIGEO demonstrated 25.5 months in median duration of continued response

In skinb,e:

  • POTELIGEO patients showed a 42% (n=78/186) response rate, more than 2 times greater than the rate in vorinostat patients (n=29/186) (ad hoc analysis of secondary endpoint)
  • POTELIGEO patients (n=78) achieved a median 20.6-month duration of continued response, compared to 10.7 months in vorinostat patients (post hoc analysis)d

In lymph nodesf,g:

  • POTELIGEO patients showed a 15% (n=21/136) response rate, more than 3 times greater than the rate in vorinostat patients (n=5/133) (ad hoc analysis of secondary endpoint)
  • POTELIGEO patients (n=21) achieved a median 15-month duration of continued response; vorinostat patients were not estimable (post hoc analysis)d

In visceraf:

  • No response was observed in viscera in either treatment group (POTELIGEO 0% [n=6]; vorinostat 0% [n=4])
  • aResponse was defined by current international response criteria for mycosis fungoides (MF) and Sézary syndrome (SS).4
  • bResponses in blood and skin must have persisted for ≥4 weeks to be confirmed and were evaluated every 4 weeks during treatment.1,5
  • cResponse in blood defined as >50% decrease in blood tumor burden, assessed by central flow cytometry.5
  • d Duration of 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.
  • eResponse in skin defined as ≥50% clearance of skin disease without new tumors, evaluated using the modified Severity Weighted Assessment Tool (mSWAT).5
  • fResponses in lymph nodes and viscera were evaluated at 4 weeks, then every 8 weeks for the first year, and every 16 weeks thereafter.2
  • gResponses in lymph nodes defined as cumulative reduction ≥50% of measurable disease of each abnormal lymph node and no new abnormal lymph nodes, evaluated by computed tomography (CT) scans.5
  • CR=complete response; PR=partial response

POTELIGEO had a median time to response of about 1 month in blood2,h-n

POTELIGEO also had a median time to response of 3 months in skin

POTELIGEO had a median time to response of 3 months in skin
  • h Time 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.
  • iResponse was defined by current international response criteria for MF and SS.4
  • jResponses in blood and skin must have persisted for ≥4 weeks to be confirmed and were evaluated every 4 weeks during treatment.1,5
  • kResponses in lymph nodes were evaluated at 4 weeks, then every 8 weeks for the first year and every 16 weeks thereafter.5
  • lResponse defined as ≥50% clearance of skin disease without new tumors, evaluated using the modified Severity Weighted Assessment Tool (mSWAT).5
  • mResponse defined as >50% decrease in blood tumor burden, assessed by central flow cytometry.5
  • nResponse defined as cumulative reduction ≥50% of measurable disease of each abnormal lymph node and no new abnormal lymph nodes, evaluated by computed tomography (CT) scans.5

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)1,2,6

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 CLASSIFICATION7

  • (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 characteristics1,3
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 criteria5
  • 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 is administered in 28-day cycles1

Review dosing schedule
References:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, 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. Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.
  4. Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2011;29(18):2598-2607.
  5. 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.
  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].
  7. 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.

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.