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TRODELVY® (sacituzumab govitecan-hziy) 180 mg for injection logo

For the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease

For the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease

In the full population of ASCENT

Median OS of ~1 year with TRODELVY1

TRODELVY significantly improved survival versus single-agent chemotherapy1,2

Kaplan-Meier estimates of median OS (full population)

0 0 3 6 9 12 15 18 21 24 20 40 60 80 100 Time (months) Overall survival (%) Single-agent chemotherapy (n=262) TRODELVY (n=267) Single-agent chemotherapy 262 192 132 84 52 34 14 5 1 267 242 208 164 116 76 39 13 0 TRODELVY Number of patients at risk MONTHS 11.8 (95% CI: 10.5–13.8) MONTHS 6.9 (95% CI: 5.9–7.6) HR: 0.51(95% CI: 0.41–0.62)P<0.0001 49% reduction in the risk of death

Reproduced with permission from Bardia et al, N Engl J Med, 2021; copyright Massachusetts Medical Society.

2L=second line; brain-met=brain metastases; CI=confidence interval; HR=hazard ratio; OS=overall survival.

Please see primary analysis (brain-met–negative) and brain-met–positive data below.

In the primary analysis (brain-met–negative) population of ASCENT

Median OS of 1 year with TRODELVY2

Statistically significant results were demonstrated versus patients treated with single-agent chemotherapy across both the primary analysis and full populations1,2

Secondary endpoint: Kaplan-Meier estimates of median OS (brain-met–negative population)2

0 0 3 6 9 12 15 18 21 24 27 20 40 60 80 100 Time (months) Overall survival (%) Single-agent chemotherapy (n=233) TRODELVY (n=235) Single-agent chemotherapy 233 173 117 74 45 30 11 3 1 235 214 190 153 107 70 37 13 0 TRODELVY Number of patients at risk MONTHS 12.1 (95% CI: 10.7–14.0) MONTHS 6.7 (95% CI: 5.8–7.7) HR: 0.48(95% CI: 0.38–0.59)P<0.001 52% reduction in the risk of death

Reproduced with permission from Bardia et al, N Engl J Med, 2021; copyright Massachusetts Medical Society.

Please see full population data above and brain-met–positive data below.

Exploratory findings in previously treated, stable brain-met–positive patients1

Median OS

6.8 months with TRODELVY (95% CI: 4.7–14.1) versus 7.4 months with single-agent chemotherapy (95% CI: 4.7–11.1); HR: 0.87 (95% CI: 0.47–1.63)

In the ASCENT study:

  • MRI was required prior to enrollment to determine existence or extent of known or suspected brain metastases
  • Patients with brain metastases were allowed to enroll up to a predefined maximum of 15% of study patients
  • 12% of patients had baseline brain metastases previously treated and stable (n=61; 32 on TRODELVY arm and 29 on single-agent chemotherapy arm)

MRI=magnetic resonance imaging.

In a post-hoc subgroup of the ASCENT study of patients without brain metastases

Median OS of TRODELVY versus 4 single-agent chemotherapies in the comparator arm3*

88% of patients in the ASCENT study were brain-met–negative, and OS results of this sub-analysis were consistent with the ASCENT findings1-3

In this post-hoc subgroup analysis of ASCENT, Kaplan-Meier estimates of median OS by BICR based on RECIST 1.1 criteria (brain-met–negative population)3

0 0 3 6 9 12 15 18 21 24 20 40 60 80 100 Time (months) Overall survival (%) Number of patients at risk TRODELVY Eribulin Vinorelbine Capecitabine Gemcitabine 235 126 47 31 29 214 98 31 23 21 190 68 20 12 17 153 42 13 8 11 107 25 8 7 5 70 16 5 5 4 37 7 1 2 1 13 3 0 0 0 0 1 0 0 0 HR: 0.48 (95% CI: 0.38–0.59) TRODELVY (n=235) 12.1 months (95% Cl: 10.7–14.0) 6.9 months (95% Cl: 5.8–7.8) Eribulin (n=126) 5.9 months (95% Cl: 4.5–6.7) Vinorelbine (n=47) 8.4 months (95% Cl: 5.0–9.6) Gemcitabine (n=29) 5.2 months (95% Cl: 3.5–8.6) Capecitabine (n=31) Single-agent chemotherapy (n=233) T G C V E T G C V E

*Limitation: These results are from a post-hoc subgroup analysis of the Phase 3 ASCENT study. The single-agent chemotherapy arms were not powered for statistical analysis or designed to compare against individual agents and should be considered descriptive only. Therefore, the results require cautious interpretation and could represent chance findings.

BICR=blinded, independent, central review; RECIST=Response Evaluation Criteria in Solid Tumors.

Safety findings from this post-hoc subgroup analysis of ASCENT3

Single-agent chemotherapy (n=224)
TRODELVY
(n=258)		 Eribulin
(n=123)		 Vinorelbine + capecitabine + gemcitabine
(n=101)
Treatment-related adverse eventsa All grades
(%)		 Grade 3/4
(%)		 All grades
(%)		 Grade 3/4
(%)		 All grades
(%)		 Grade 3/4
(%)
Hematologic
Neutropeniab 63 51 39 31 48 36
Anemiab 34 8 23 2 26 8
Leukopeniab 16 10 11 5 11 6
Febrile neutropenia 6 6 2 2 2 2
Gastrointestinal
Diarrhea 59 10 8 0 17 1
Nausea 57 3 29 1 23 0
Vomiting 29 1 11 1 9 0
Other
Alopecia 46 0 25 0 4 0
Fatigue 45 3 31 5 30 6
  • Discontinuation rates due to treatment-emergent adverse events for TRODELVY, eribulin, vinorelbine, capecitabine, and gemcitabine were 5%, 2%, 10%, 7%, and 9%, respectively
  • One treatment-related death was reported for the single-agent chemotherapy arm (eribulin; neutropenic sepsis) and none with TRODELVY

aPatients may report more than 1 event per preferred term. Adverse events (AEs) were coded using MedDRA v22.1, and AE severity was graded per NCI CTCAE v4.03.

bNeutropenia contains combined preferred terms of neutropenia and decreased neutrophil count, anemia contains combined preferred terms of anemia and decreased hemoglobin, and leukopenia combines preferred terms of leukopenia and decreased white blood cell count; all are counted once for each preferred term.

MedDRA=Medical Dictionary for Regulatory Activities; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

References: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; February 2023. 2. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. 3. O’Shaughnessy J, Punie K, Oliveira M, et al. Assessment of sacituzumab govitecan vs treatment of physician’s choice cohort by agent in the phase 3 ASCENT study of patients with metastatic triple-negative breast cancer. Poster presented at: Virtual American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021.

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INDICATION

TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: NEUTROPENIA AND DIARRHEA
  • Severe or life-threatening neutropenia may occur. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
  • Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS
  • Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Administer G-CSF as clinically indicated or indicated in Table 1 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with TRODELVY. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study, the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.