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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 ASCENT study, TRODELVY demonstrated

Nearly 3x longer median PFS versus single-agent chemotherapy1

TRODELVY demonstrated significantly longer median PFS versus single-agent chemotherapy in the full population, which consisted of both brain-met–negative (88%) and brain-met–positive (12%) patients

Kaplan-Meier estimates of median PFS by BICR based on RECIST 1.1 criteria (full population)1*

0 0 3 6 9 12 15 18 21 24 20 40 60 80 100 Time (months) Progression-free survival (%) Single-agent chemotherapy (n=262) TRODELVY (n=267) Single-agent chemotherapy 262 41 13 6 2 1 0 0 0 267 TRODELVY Number of patients at risk MONTHS 4.8 (95% CI: 4.1–5.8) MONTHS 1.7 (95% CI: 1.5–2.5) 57% reduction in the risk of disease progression or death HR: 0.43(95% CI: 0.35–0.54 P<0.0001 145 82 38 23 14 8 1 0
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Please see primary endpoint analysis and brain-met–positive data below.

*PFS is defined as the time from the date of randomization to the date of the first radiological disease progression or death due to any cause, whichever comes first.

2L=second line; BICR=blinded, independent, central review; brain-met=brain metastases; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

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

3x longer median PFS versus single-agent chemotherapy2

88% of patients in the full population were brain-met–negative

Primary endpoint: Kaplan-Meier estimates of median PFS by BICR based on RECIST 1.1 criteria (brain-met–negative population)1†

0 20 40 60 80 100 Time (months) Progression-free survival (%) Single-agent chemotherapy (n=233) TRODELVY (n=235) 59% Single-agent chemotherapy 233 39 14 5 1 1 0 0 235 154 91 49 28 15 9 1 TRODELVY Number of patients at risk MONTHS 5.6 (95% CI: 4.3–6.3) MONTHS 1.7 (95% CI: 1.5–2.6) 59% reduction in the risk of disease progression or death HR: 0.41(95% CI: 0.32–0.52) P<0.001 0 3 6 9 12 15 18 21 24
f

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.

†PFS is defined as the time from the date of randomization to the date of the first radiological disease progression or death due to any cause, whichever comes first.

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

Median PFS

2.8 months with TRODELVY (95% CI: 1.5–3.9) versus 1.6 months with single-agent chemotherapy (95% CI: 1.3–2.9); HR: 0.65 (95% CI: 0.35–1.22)

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.

Discover TRODELVY in 2L and later mTNBC with Yuan Yuan, MD, PhD

Director of Breast Oncology, Cedars-Sinai Cancer Center

TRODELVY® (sacituzumab govitecan-hziy) Yuan Yuan video about ASCENT trial
PLEASE CLICK HERE FOR FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING.

In a subgroup analysis of ASCENT

PFS results across subgroups in the primary analysis population1§

88% of patients in the ASCENT study were brain-met–negative (primary analysis population), and PFS results of this sub-analysis were generally consistent with the ASCENT primary findings

§Limitation: These results are from a subgroup analysis of the Phase 3 ASCENT study. This secondary endpoint was not powered for statistical analysis and should be considered descriptive only. Therefore, the results require cautious interpretation and could represent chance findings.

Median PFS by BICR based on RECIST 1.1 criteria and hazard ratio for disease progression or death (brain-met–negative population)2

Hazard ratio for diseaseprogression or death (95% CI) 100% 81% 19% 79% 12% 71% 29% 64% 36% 27% 73% 43% 57% 69% 31% 4% Negative <65 yr ≥65 yr White Black 2 or 3 >3 North America Rest of the world Yes No Yes No Yes No Asian Age Previous use of PD-1 or PD-L1 inhibitors Liver metastasis Initial diagnosis of TNBC Race Geographic region Previous therapies Brain-met population 0.06 0.12 0.25 0.50 1.00 2.00 4.00 8.00 16.00 TRODELVY Single-agentchemotherapy 0.41 (0.32-0.52) 0.46 (0.35-0.59) 0.22 (0.12-0.40) 0.39 (0.30-0.51) 0.45 (0.24-0.86) 0.40 (0.08-2.08) 0.39 (0.29-0.52) 0.48 (0.32-0.72) 0.44 (0.33-0.60) 0.36 (0.24-0.53) 0.37 (0.24-0.57) 0.42 (0.32-0.56) 0.48 (0.34-0.67) 0.36 (0.26-0.50) 0.38 (0.29-0.51) 0.48 (0.32-0.72) Subgroup % of patientsN=468 5.6 (4.3-6.3) 4.6 (3.7-5.7) 7.1 (5.8-8.9) 5.7 (4.3-6.8) 5.4 (2.8-7.4) 5.8 (4.2-7.1) 5.6 (3.0-6.5) 4.9 (4.0-6.3) 5.9 (4.2-6.9) 4.2 (3.2-5.6) 6.2 (4.9-7.1) 4.2 (2.8-5.8) 6.8 (4.6-8.0) 5.7 (4.3-6.9) 4.6 (3.7-6.9) NE (1.3-NE) TRODELVY months (95% CI) Progression-free survival 1.7 (1.5-2.6) 1.7 (1.5-2.5) 2.4 (1.4-2.9) 1.7 (1.5-2.6) 2.2 (1.5-2.9) 1.6 (1.5-2.5) 2.5 (1.5-2.8) 2.0 (1.5-2.6) 1.6 (1.4-2.7) 1.6 (1.4-2.3) 2.1 (1.5-2.7) 1.5 (1.4-2.4) 2.3 (1.6-2.7) 1.6 (1.5-2.6) 2.3 (1.5-2.8) 1.5 (1.2-NE) Single-agentchemotherapy TRODELVY Single-agentchemotherapy
Use buttons to toggle between hazard ratio and Progression-Free Survival
HR PFS
Subgroup % of patients
N=468		 Progression-Free Survivalmonths (95% CI)
Subgroup % of patients
N=468		 Hazard ratio for disease
progression or death (95% CI)
Brain-met population
100% 5.6 (4.3-6.3) 1.7 (1.5-2.6) Negative
100% Negative 0.41 (0.32-0.52)
Age
81% 19% <65 yr ≥65 yr 4.6 (3.7-5.7) 7.1 (5.8-8.9) 1.7 (1.5-2.5) 2.4 (1.4-2.9)
81% 19% <65 yr ≥65 yr 0.46 (0.35-0.59) 0.22 (0.12-0.40)
Race
79% 12% 4% White Black Asian 5.7 (4.3-6.8) 5.4 (2.8-7.4) NE (1.3-NE) 1.7 (1.5-2.6) 2.2 (1.5-2.9) 1.5 (1.2-NE)
79% 12% 4% White Black Asian 0.39 (0.30-0.51) 0.45 (0.24-0.86) 0.40 (0.08-2.08)
Previous therapies
71% 29% 2 or 3 >3 5.8 (4.2-7.1) 5.6 (3.0-6.5) 1.6 (1.5-2.5) 2.5 (1.5-2.8)
71% 29% 2 or 3 >3 0.39 (0.29-0.52) 0.48 (0.32-0.72)
Geographic region
64% 36% North America Rest of the world 4.9 (4.0-6.3) 5.9 (4.2-6.9) 2.0 (1.5-2.6) 1.6 (1.4-2.7)
64% 36% North America Rest of the world 0.44 (0.33-0.60) 0.36 (0.24-0.53)
Previous use of PD-1 or PD-L1 inhibitors
27% 73% Yes No 4.2 (3.2-5.6) 6.2 (4.9-7.1) 1.6 (1.4-2.3) 2.1 (1.5-2.7)
27% 73% Yes No 0.37 (0.24-0.57) 0.42 (0.32-0.56)
Liver metastasis
43% 57% Yes No 4.2 (2.8-5.8) 6.8 (4.6-8.0) 1.5 (1.4-2.4) 2.3 (1.6-2.7)
43% 57% Yes No 0.48 (0.34-0.67) 0.36 (0.26-0.50)
Initial diagnosis of TNBC
69% 31% Yes No 5.7 (4.3-6.9) 4.6 (3.7-6.9) 1.6 (1.5-2.6) 2.3 (1.5-2.8)
69% 31% Yes No 0.38 (0.29-0.51) 0.48 (0.32-0.72)

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

NE=not evaluable; PD-1=programmed death receptor-1; PD-L1=programmed death-ligand 1; yr=year.

In a separate post-hoc subgroup analysis* of patients without brain metastases in the ASCENT study

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

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

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

0 20 40 60 80 100 Time (months) Progression-free survival (%) Number of patients at risk TRODELVY T G C HR: 0.41 (95% CI: 0.32–0.52) TRODELVY (n=235) 5.6 months (95% Cl: 4.3–6.3) 2.1 months (95% Cl: 1.5–2.8) Eribulin (n=126) 1.6 months (95% Cl: 1.4–2.7) Vinorelbine (n=47) 2.7 months (95% Cl: 1.6–4.8) Gemcitabine (n=29) 1.6 months (95% Cl: 1.4–2.4) Capecitabine (n=31) Single-agent chemotherapy (n=233) T C V E G 3 0 6 9 12 15 18 21 24 235 134 81 37 22 13 8 1 126 23 5 2 1 0 0 0 47 3 1 1 0 0 0 0 31 5 3 2 1 1 0 0 29 4 3 1 0 0 0 0 Eribulin Vinorelbine Capecitabine Gemcitabine V E E
f 0 3 6 9 1 2 1 5 1 8 2 1 2 4 0 2 0 4 0 6 0 8 0 1 0 0 V G

*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.

†PFS is defined as the time from the date of randomization to the date of the first radiological disease progression or death due to any cause, whichever comes first.

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.