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

Safety

TRODELVY HAS A WELL-CHARACTERIZED SAFETY PROFILE IN UNRESECTABLE LOCALLY ADVANCED OR mTNBC

Adverse reactions in ≥10% of patients with mTNBC in the ASCENT trial1

*Single-agent chemotherapy included one of the following single agents: eribulin (n=139), capecitabine (n=33), gemcitabine (n=38), or vinorelbine (except if patient had ≥Grade 2 neuropathy, n=52). Graded per NCI CTCAE v.5.0. Including neutropenia and neutrophil count decreased. Including anemia, hemoglobin decreased, and red blood cell count decreased. §Including leukopenia and white blood cell count decreased. IIIncluding lymphopenia and lymphocyte count decreased. Including stomatitis, glossitis, mouth ulceration, and mucosal inflammation. IIIncluding fatigue and asthenia.

Select laboratory abnormalities in >10% of patients with mTNBC in ASCENT1

Serious adverse reactions1

  • Serious adverse reactions occurred in 27% of patients receiving TRODELVY
  • Serious adverse reactions in >1% of patients receiving TRODELVY included neutropenia (7%), diarrhea (4%), and pneumonia (3%)
  • Fatal adverse reactions occurred in 1.2% of patients who received TRODELVY, including respiratory failure (0.8%) and pneumonia (0.4%)

Most common adverse reactions1

  • The most common adverse reactions in ASCENT (≥25%) were fatigue (65%), neutropenia (64%), diarrhea (59%), nausea (57%), alopecia (47%), anemia (40%), constipation (37%), vomiting (33%), abdominal pain (30%), and decreased appetite (28%)
  • In the pooled safety population (n=795), the most common (≥25%) adverse reactions were neutropenia (61%), nausea (66%), diarrhea (65%), fatigue (62%), alopecia (45%), anemia (42%), vomiting (39%), constipation (37%), decreased appetite (34%), rash (32%), and abdominal pain (28%)

Treatment discontinuation1

  • Adverse reactions leading to permanent discontinuation in ≥1% of patients who received TRODELVY were pneumonia (1%) and fatigue (1%)
  • Adverse reactions leading to permanent discontinuation of TRODELVY occurred in 5% of patients

Treatment interruption1

  • Adverse reactions leading to a treatment interruption occurred in 63% of patients
  • The most frequent (≥5%) adverse reactions leading to a treatment interruption were neutropenia (47%), diarrhea (5%), respiratory infection (5%), and leukopenia (5%)

Dose reductions1

  • Adverse reactions leading to a dose reduction occurred in 22% of patients
  • The most frequent (>4%) adverse reactions leading to a dose reduction were neutropenia (11%) and diarrhea (5%)
    • Granulocyte colony-stimulating factor (G-CSF) was used in 44% of patients who received TRODELVY
Reference: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; April 2021.