Trojan horses encapsulated by a TRODELVYᵀᴹ cell membrane in a green, cellular environment.

Safety

SAFETY PROFILE OF TRODELVY

Adverse reactions in ≥10% of patients with mTNBC who had received at least 2 prior therapies for metastatic disease

Adverse reactionTRODELVY (n=108)
Any Grade 1-4Grade 3-4

Any adverse reaction

100%71%

Gastrointestinal disorders

95%21%
Nausea69%6%
Diarrhea63%9%
Vomiting49%6%
Constipation34%1%
Abdominal paini26%1%
Mucositisii14%1%

General disorders and administration site conditions

77%9%
Fatigueiii57%8%
Edemaiv19%0%
Pyrexia14%0%

Blood and lymphatic system disorders

74%37%
Neutropenia64%43%
Anemia52%12%
Thrombocytopenia14%3%

Metabolism and nutrition disorders

68%22%
Decreased appetite30%1%
Hyperglycemia24%4%
Hypomagnesemia21%1%
Hypokalemia19%2%
Hypophosphatemia16%9%
Dehydration13%5%

Skin and subcutaneous tissue disorders

63%4%
Alopecia38%0%
Rashv31%3%
Pruritis17%0%
Dry Skin15%0%

Nervous system disorders

56%4%
Headache23%1%
Dizziness22%0%
Neuropathyvi24%0%
Dysgeusia11%0%

Infections and infestations

55%12%
Urinary tract infection21%3%
Respiratory infectionvii26%3%

Musculoskeletal and connective tissue disorders

54%1%
Back pain23%0%
Arthralgia17%0%
Pain in extremity11%0%

Respiratory, thoracic, and mediastinal disorders

54%5%
Coughviii22%0%
Dyspneaix21%3%

Psychiatric disorders

26%1%
Insomnia13%0%
Graded per NCI CTCAE v. 4.0 iIncluding abdominal pain, distention, pain (upper), discomfort, and tenderness. iiIncluding stomatitis, esophagitis, and mucosal inflammation. iiiIncluding fatigue and asthenia. ivIncluding edema; and peripheral, localized, and periorbital edema. vIncluding rash; maculopapular, erythematous, and generalized rash; dermatitis acneiform; skin disorder, irritation, and exfoliation. viIncluding gait disturbance, hypoesthesia, muscular weakness, paresthesia, and peripheral and sensory neuropathy. viiIncluding lower and upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis, and respiratory syncytial virus infection. viiiIncludes cough and productive cough. ixIncludes dyspnea and exertional dyspnea.
  • Serious adverse reactions were reported in 31% of patients
  • The most frequent serious adverse reactions (reported in >1%) of the patients were febrile neutropenia (6%), vomiting (5%), diarrhea (4%), nausea (3%), dyspnea (3%), anemia, dehydration, pleural effusion, neutropenia, and pneumonia (each 2%)

Most patients who receive TRODELVY experience lab abnormalities. See Table 3 in the PI for complete listing.

 

Reference: 1. Data on file.