2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse Reactions The data described below reflect exposure to POTELIGEO in a randomized, open-label, actively controlled clinical trial (Study 0761-010) for adult patients with MF or SS who received at least one prior systemic therapy.
Of 370 patients treated, 184 (57% with MF, 43% with SS) received POTELIGEO as randomized treatment and 186 (53% with MF, 47% with SS) received vorinostat. 135 (73%) patients randomized to receive vorinostat crossed over to POTELIGEO.
A total of 319 patients received POTELIGEO. POTELIGEO was administered at 1 mg/kg intravenously over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of subsequent 28-day cycles. Premedication (diphenhydramine, acetaminophen) was optional and administered to 65% of randomized patients for the first infusion.
The comparator group received vorinostat 400 mg orally once daily, given continuously in 28-day cycles. Treatment continued until unacceptable toxicity or progressive disease. The median age was 64 years (range, 25 to 101 years), 58% of patients were male, 70% were white, and 99% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patients had a median of 3 prior systemic therapies. 5 times upper limit of normal (ULN) (≤5 POTELIGEO (mogamulizumab for injection) Page 11 of 25 times ULN if lymphomatous liver infiltration). Patients with active autoimmune disease, active infection, autologous HSCT within 90 days, or prior allogeneic HSCT were excluded.
6 months, with 48% (89/184) of patients with at least 6 months of exposure and 23% (43/184) with at least 12 months of exposure. 8 months, with 22% (41/186) of patients with at least 6 months of exposure. 6%). 1% (13/184). Table 1 summarizes common adverse reactions having a >2% higher incidence with POTELIGEO than with vorinostat in Study 0761-010.
Table 1 Common Adverse Reactions (≥10%) with ≥2% Higher Incidence in the POTELIGEO Arm Adverse Reactions by Body System a, b, c Vorinostat (N=186) POTELIGEO (N=184) Crossover to POTELIGEO (N=135) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) Skin and Subcutaneous Tissue Disorders Rash, Including Drug Eruption 22 (12) 2 (1) 67 (36) 7 (4) 54 (40) 5 (4) Drug Eruption 2 (1) 0 46 (25) 9 (5) 37 (27) 4 (3) Procedural Complications Infusion Related Reaction 1 (<1) 0 61 (33) 3 (2) 51 (38) 6 (4) Infections Upper Respiratory Tract Infection 29 (16) 2 (1) 40 (22) 0 28 (21) 0 Skin Infection 25 (13) 6 (3) 34 (18) 5 (3) 21 (16) 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal Pain 32 (17) 3 (2) 40 (22) 1 (<1) 31 (23) 0 General Disorders Pyrexia 12 (6) 0 33 (18) 1 (<1) 17 (13) 0 Gastrointestinal Mucositis 11 (6) 0 26 (14) 2 (1) 19 (14) 0 a Adverse reactions include groupings of individual preferred terms.
b Includes adverse reactions reported up to 90 days after randomized treatment. c Includes all common adverse reactions only (≥10%) for the crossover group. Rash/Drug Eruption includes: dermatitis (allergic, atopic, bullous, contact, exfoliative, infected), drug eruption, palmoplantar keratoderma, rash (generalized, macular, maculopapular, papular, pruritic, pustular), skin reaction, toxic skin eruption Upper Respiratory Tract Infection includes: laryngitis viral, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection POTELIGEO (mogamulizumab for injection) Page 12 of 25 Adverse Reactions by Body System a, b, c Vorinostat (N=186) POTELIGEO (N=184) Crossover to POTELIGEO (N=135) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) Skin Infection includes: cellulitis, dermatitis infected, erysipelas, impetigo, infected skin ulcer, periorbital cellulitis, skin bacterial infection, skin infection, staphylococcal skin infection Musculoskeletal Pain includes: back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, pain in extremity Mucositis includes: aphthous stomatitis, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, stomatitis Other Common Adverse Reactions in ≥10% of POTELIGEO Arm a, b • General disorders: fatigue (31%), edema (17%) • Gastrointestinal disorders: diarrhea (30%), nausea (17%), constipation (13%) • Blood and lymphatic system disorders: thrombocytopenia (14%), anemia (12%) • Nervous […]