ESTABLISHED SAFETY PROFILE OF TRODELVY IN LOCALLY ADVANCED OR mUC
Most common adverse reactions 1
- The most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash
- 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%)
Serious adverse reactions 1
- Serious adverse reactions occurred in 44% of patients receiving TRODELVY
- Serious adverse reactions in >1% of patients receiving TRODELVY included infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), sepsis or bacteremia (5%), diarrhea (4%), anemia, venous thromboembolism, and small intestinal obstruction (3% each), pneumonia, abdominal pain, pyrexia, and thrombocytopenia (2% each)
- Fatal adverse reactions occurred in 3.6% of patients, including sepsis, respiratory failure, epistaxis, and completed suicide
Treatment discontinuation 1
- Adverse reactions leading to permanent discontinuation of TRODELVY occurred in 10% of patients
- The most frequent adverse reaction leading to permanent discontinuation of study drug was neutropenia (4%, including febrile neutropenia in 2%)
Treatment interruption 1
- Adverse reactions leading to a treatment interruption of TRODELVY occurred in 52% of patients
- The most common adverse reactions leading to dose interruption were neutropenia (27%, including febrile neutropenia in 2%), infection (12%), and acute kidney injury (8%)
Dose reductions 1
- Adverse reactions leading to a dose reduction of TRODELVY occurred in 42% of patients. The most common (>4%) adverse reactions leading to a dose reduction were neutropenia (13%, including febrile neutropenia in 3%), diarrhea (11%), fatigue (8%), and infection (4%)
- Granulocyte colony-stimulating factor (G-CSF) was used in 47% of patients who received TRODELVY
Additional safety data 1
- Other clinically significant adverse reactions (≤15%) include: peripheral neuropathy (12%), sepsis or acteremia (9%), and pneumonia (4%)
- Cases of Grade 3-4 neuropathy were not reported in Cohort 1 of TROPHY
Adverse reactions reported in ≥15% (Grade 1-4) or ≥5% (Grade ≥3) of patients treated with TRODELVY (N=113)1
*Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain.
†Includes fatigue and asthenia.
‡Includes edema genital, edema peripheral, peripheral swelling.
§Includes dermatitis acneiform, dermatitis bullous, erythema, lichen planus, photosensitivity reaction, pruritus, pruritus generalized, rash, rash macular, rash maculopapular, rash pruritic, skin papilloma, skin toxicity.
||Includes failure to thrive and weight decreased.
¶Includes acute kidney injury, blood creatinine increased, nephropathy toxic, renal failure, renal impairment.
#Includes bacteremia, body tinea, bronchitis, candida infection, cellulitis, clostridium difficile infection, coronavirus infection, device-related infection, diverticulitis, escherichia bacteremia, escherichia pyelonephritis, folliculitis, gastroenteritis, gastroenteritis escherichia coli, herpes zoster, kidney infection, klebsiella sepsis, lung infection, nasopharyngitis, oral candidiasis, oral herpes, pneumonia, pyelonephritis, pyelonephritis acute, respiratory tract infection, rhinitis, sepsis, sinusitis, skin infection, tooth abscess, upper respiratory tract infection, urinary tract infection, urosepsis, vascular device infection, viral infection, viral pharyngitis, vulvovaginal mycotic infection.
**Includes cough, productive cough, upper-airway cough syndrome.
††Includes deep vein thrombosis, embolism, and pulmonary embolism.
Selected laboratory abnormalities reported in ≥20% (any grade) or ≥5% (Grade 3-4) of patients treated with TRODELVY (N=113)1
‡‡Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available (range: 66 to 111 patients).
Reference: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; April 2021. 2. Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors [published online ahead of print April 30, 2021]. J Clin Oncol. doi:10.1200/JCO.20.03489