1L mTNBC Efficacy and Safety Data
TRODELVY is the backbone therapy for your patients with 1L mTNBC
Two new indications in 1L mTNBC
TRODELVY as a single agent is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple- negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.
TRODELVY, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test.
GUIDELINES
National Comprehensive Cancer Network® (NCCN® ) recommendations
The only ADC with an NCCN Category 1 preferred designation in 1L mTNBC across PD-L1 status1
MonotherapyIn combination with pembrolizumab
Monotherapy
In combination with pembrolizumab
The NCCN recommendations differ from the sacituzumab govitecan-hziy (TRODELVY) Prescribing Information.
Category 1 indicates that based upon high-level evidence (≥1 randomized Phase 3 trials or high-quality, robust meta-analysis), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
aProgrammed death ligand 1 (PD-L1) expression is assessed using 22C3 antibody. Threshold for positivity combined positive score (CPS) ≥10.
bAssess for germline BRCA1/2 PVs in all patients with recurrent or metastatic breast cancer to identify candidates for PARPi therapy.
cSee NCCN Guidelines for Hematopoietic Growth Factors.
dSacituzumab govitecan-hziy may be considered for second or later line if not used in a previous line of therapy.
EFFICACY DATA
TRODELVY has been evaluated vs traditional chemotherapy in 2 landmark studies for 1L mTNBC2-4
TRODELVY as monotherapy for patients with PD-1 or PD-L1 inhibitor-ineligible tumors
ASCENT-03 Study Design: A Phase 3, randomized, active-controlled, multicenter, open-label study (N=558) evaluating the efficacy and safety of TRODELVY vs 1L chemotherapiesa in patients with unresectable locally advanced or metastatic TNBC who had not received previous systemic therapy for advanced disease and who were not candidates for PD-1 or PD-L1 inhibitor therapy. The primary endpoint of PFS was assessed by BICR per RECIST v1.1 criteria.2,3
aChemotherapy was determined by the investigator before randomization from one of the following regimens: gemcitabine and carboplatin, paclitaxel, or nab-paclitaxel.2
ASCENT-03: A randomized, open-label, active-controlled Phase 3 study2,3
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aPatients were excluded if they had received anticancer treatment or surgery within the previous 6 months, had active central nervous system (CNS) metastases, and ECOG performance status (PS) >1.1
bAll study medications were administered by IV infusion.1
cAssessment of tumor status was performed every 6 weeks for the first year followed by every 12 weeks thereafter. Crossover to TRODELVY monotherapy was allowed at the time of disease progression and study treatment discontinuation.1
dAs assessed by BICR per RECIST version 1.1.2
The population of ASCENT-03 has characteristics that may resemble those of your patients2
ITT Population
DEMOGRAPHICS |
TRODELVY (n=279)
|
|
|---|---|---|
Sex |
99.5% female | |
Median Age (Range), yr |
55 (23–86) | |
≥65 yr |
26% | |
Race |
||
White |
64% | |
Asian |
23% | |
American Indian or Alaskan Native |
4.5% | |
Black |
3% | |
Not specified |
5.2% | |
ETHNICITY |
||
Non-Hispanic/non-Latino |
72% | |
Hispanic/Latino |
27% | |
Not reported |
0.9% | |
DISEASE CHARACTERISTICS |
TRODELVY (n=279)
|
|
|---|---|---|
ECOG Performance Status Score |
||
0 |
66% | |
1 |
34% | |
Disease Status |
||
De novo disease |
31% | |
Recurrent disease with a disease-free interval (DFI) of 6 to 12 months |
21% | |
Recurrent disease with a DFI >12 months |
48% | |
Metastatic Sites |
||
Visceral metastasis at baseline |
76% | |
Brain |
5% | |
TUMOR CPS STATUS |
||
Tumor CPS <10 |
99.5% | |
Tumor CPS ≥10 |
0.4% | |
TRODELVY in combination with pembrolizumab for patients with PD-1 or PD-L1 inhibitor-eligible tumors
ASCENT-04: A Phase 3, randomized, active-controlled, multicenter, open-label study (N=443) evaluating the efficacy and safety of TRODELVY + pembrolizumab vs 1L chemotherapya + pembrolizumab in patients with unresectable locally advanced or metastatic TNBC who had not received previous systemic therapy for advanced disease and whose tumors expressed PD-L1.b The primary endpoint of PFS was assessed by BICR per RECIST v1.1 criteria.2,4
aChemotherapy was determined by the investigator before randomization from one of the following regimens: gemcitabine and carboplatin, paclitaxel, or nab-paclitaxel.2
bDefined as CPS ≥10 according to the PD-L1 IHC 22C3 pharmDx assay.2
ASCENT-04: A randomized, open-label, active-controlled Phase 3 study2,4
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aPatients with active autoimmune disease that required systemic therapy within 2 years or treatment for a medical condition that required immunosuppression were ineligible.1
bAll study medications were administered by IV infusion.1
cAssessment of tumor status was performed every 8 weeks for the first 18 months followed by every 12 weeks thereafter. Treatment beyond BICR-verified PD per RECIST was permitted if the patient was clinically stable and there was evidence of clinical benefit per the investigator. Crossover to TRODELVY monotherapy was allowed following disease progression and study treatment discontinuation.1
dBy BICR per RECIST v1.1.2
The population of ASCENT-04 has characteristics that may resemble those of your patients2
ITT Population
DEMOGRAPHICS |
TRODELVY + pembrolizumab
|
|
|---|---|---|
Sex |
100% female | |
Median Age (Range), yr |
55 (23–88) | |
≥65 yr |
26% | |
Race |
||
White |
58% | |
Asian |
24% | American Indian or Alaska Native |
6% |
Black |
5% | |
Not specified |
6.5% | |
Ethnicity |
||
Hispanic/Latino |
29% | |
Non-Hispanic/non-Latino |
69% | |
Not reported |
2% | |
DISEASE CHARACTERISTICS |
TRODELVY + pembrolizumab |
|
|---|---|---|
ECOG Performance Status Score |
||
0 |
70% | |
1 |
30% | |
2 |
0.2% | |
Disease Status |
||
De novo metastatic disease |
34% | |
Recurrent disease with |
18% | |
Recurrent DFI of >12 months |
48% | |
Metastatic Sites |
||
Visceral metastasis at baseline |
65% | |
Brain |
3% | |
TRODELVY is the only ADC proven superior to traditional 1L chemotherapies across PD-L1 status2
In patients who are PD-(L)1 inhibitor
ineligible
TRODELVY demonstrated a statistically significant mPFS benefit vs chemotherapy2
Primary endpoint: PFS by BICR per RECIST 1.1 criteria (ITT population) in ASCENT-032,a
- In an exploratory analysis at prespecified time points, the 12-month PFS rate was 41% with TRODELVY (95% CI: 34-47) vs 24% with chemotherapy (95% CI: 19-30)3
The results do not evaluate the entire time-to-event distribution and are considered descriptive. Thus, they require cautious interpretation and could represent chance findings.
- OS data were immature at the time of interim analysis2,a
- Of the 179 patients from the TPC arm who received subsequent therapy, 82% (n=147) crossed over to TRODELVY3
aAs of April 2, 2025, the data cutoff for ASCENT-03.3
bHazard ratio based on the stratified Cox proportional hazards model.2
cTaxanes included nab-paclitaxel and paclitaxel.2
In patients who are PD-(L)1 inhibitor
eligible
TRODELVY + pembrolizumab demonstrated statistically significant mPFS benefit vs chemotherapya + pembrolizumab2
Primary endpoint: PFS by BICR per RECIST
1.1 criteria (ITT population) in
ASCENT-042,a
- In an exploratory analysis at prespecified time points, the 12-month PFS rate was 48% with TRODELVY + pembrolizumab (95% CI: 41–56) vs 33% with chemotherapy + pembrolizumab (95% CI: 26–40)4
The results do not evaluate the entire time-to-event distribution and are considered descriptive. Thus, they require cautious interpretation and could represent chance findings.
- OS data were immature at the time of interim analysis2,a
- Of the 119 patients from the TPC + pembrolizumab arm who received subsequent therapy, 81% (n=96) received TRODELVY monotherapy4
aAs of March 3, 2025, the data cutoff date for primary PFS for ASCENT-04.4
bHazard ratio based on the stratified Cox proportional hazards model.2
cTaxanes included nab-paclitaxel and paclitaxel.2
A longer duration of response was observed vs traditional 1L chemotherapies across PD-L1 status
In patients who are PD-(L)1 inhibitor
ineligible
A response was observed in half of patients receiving
TRODELVY2,a
50% ORR with TRODELVY (95% CI: 44-56; n/N=133/266) vs 47% ORR with chemotherapy (95% CI: 41-53; n/N=124/264)2,a
- CR: 7% with TRODELVY (n/N=19/266) vs 5% with chemotherapy (n/N=13/264)2
- PR: 43% with TRODELVY (n/N=114/266) vs 42% with chemotherapy (n/N=111/264)2
Duration of response by BICR in
ASCENT-033
Limitation: ORR was evaluated as part of the prespecified hierarchical testing procedure for ASCENT-03. Since an endpoint higher in the testing procedure was not mature, this data has not gone through formal statistical testing. Other endpoints shown were not included in the prespecified hierarchical testing procedure. Additionally, substantial censoring occurred in both treatment arms before median duration of response was reached. Thus, the results should be considered descriptive, require cautious interpretation, and could represent chance findings.
~2x as long median duration of response2
Data cut-off date: April 2, 2025.3
aAssessed in patients with measurable disease at baseline.2
bTaxanes included nab-paclitaxel and paclitaxel.2
In patients who are PD-(L)1 inhibitor
eligible
A response was observed in over half of patients receiving
TRODELVY2,a
61% ORR with TRODELVY + pembrolizumab (95% CI: 55–68; n/N=128/210) vs 55% ORR with chemotherapy + pembrolizumab
(95% CI: 48–62; n/N=117/213)2,a
- CR: 12% with TRODELVY + pembrolizumab (n/N=25/210) vs 8% with chemotherapy + pembrolizumab (n/N=17/213)2
- PR: 50% with TRODELVY + pembrolizumab (n/N=105/210) vs 47% with chemotherapy + pembrolizumab (n/N=100/213)2
Duration of response by BICR in
ASCENT-044,6
Limitation: ORR was evaluated as part of the prespecified hierarchical testing procedure for ASCENT-04. Since an endpoint higher in the testing procedure was not mature, this data has not gone through formal statistical testing. Other endpoints shown were not included in the prespecified hierarchical testing procedure. Additionally, substantial censoring occurred in both treatment arms before median duration of response was reached. Thus, the results should be considered descriptive, require cautious interpretation, and could represent chance findings.
Data cutoff date: March 3, 2025.4
aAssessed in patients with measurable disease at baseline.2
bTaxanes included nab-paclitaxel and paclitaxel.2
~2x as long median duration of response2
SAFETY DATA
TRODELVY has a consistent and well-characterized safety profile
Serious and fatal adverse reactions in ASCENT-03
- Serious ARs occurred in 26% of patients receiving TRODELVY2
- Serious ARs in >2% of patients receiving TRODELVY included febrile neutropenia, neutropenia, diarrhea (3.6% each), and pneumonia (2.9%)2
- Fatal adverse reactions occurred in 2.5% (n=7/275) of patients who received TRODELVY, including sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each)2
- Of the 5 patients with adverse events related to TRODELVY that led to death secondary to neutropenia, all had risk factors for febrile neutropenia (eg, advanced age, multiple coexisting conditions, or previous radiotherapy)3
- None of these patients had received primary or secondary prophylaxis with G-CSF3
Primary prophylaxis with G-CSF is recommended in the TRODELVY USPI.2
Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment for all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities.2
Prophylactic G-CSF is supported by the NCCN Guidelines® in patients at increased risk of febrile neutropenia.5
Rates of adverse reactions leading to treatment discontinuation, reduction, or interruption with TRODELVY2
- ARs that led to permanent discontinuation occurred in 3.6% of patients2,a
- ARs that led to dose interruptions occurred in 66% of patients2
- The most frequent (≥5%) ARs leading to dose interruption were decreased neutrophil count (43%), diarrhea (6%), decreased leukocyte count and COVID-19 (5% each)2
- ARs that led to dose reductions occurred in 37% of patients2
- The most frequent (>2%) ARs leading to dose reductions were decreased neutrophil count (18%), diarrhea (6%), fatigue (4.7%), febrile neutropenia (2.5%), and weight decreased (2.2%)2
AEs leading to treatment discontinuation were lower with TRODELVY vs chemotherapy (4% vs 12%)3
Most common adverse reactions and lab abnormalities in ASCENT-03
- The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count (84%), decreased leukocyte count (80%), decreased hemoglobin (78%), nausea (61%), diarrhea and alopecia (55% each), increased glucose (52%), decreased lymphocyte count and fatigue (47% each), increased alanine aminotransferase (39%), increased alkaline phosphatase and constipation (38% each), increased lactate dehydrogenase (35%), increased aspartate aminotransferase (31%), decreased potassium (28%) and vomiting (25%)2
ILD is not listed as a warning and there are no specific recommendations for monitoring for ILD in the TRODELVY USPI.2,a
aPermanent discontinuation of TRODELVY due to adverse reactions in 3.6% of patients, of which ILD accounted for 1.1%.2
Serious and fatal adverse reactions in ASCENT-04
- Serious ARs occurred in 38% of patients receiving TRODELVY + pembrolizumab2
- Serious ARs in ≥2% of patients receiving TRODELVY + pembrolizumab included febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each)2
Fatal adverse reactions occurred in 3.2% (n=7/221) of patients who received TRODELVY and pembrolizumab, including death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each).2
Primary prophylaxis with G-CSF is recommended in the TRODELVY USPI.2
Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment for all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities.2
Prophylactic G-CSF is supported by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in patients at increased risk of febrile neutropenia.5
Rates of adverse reactions leading to treatment discontinuation, reduction, or interruption with TRODELVY2
- ARs that led to permanent discontinuation occurred in 7% of patients2
- There were no common adverse reactions (≥1%) leading to permanent discontinuation of TRODELVY (0.9% infusion-related reactions)1
- ARs that led to dose interruptions occurred in 75% of patients2
- The most frequent (≥5%) ARs leading to dose interruption of TRODELVY were neutropenia (44%), upper respiratory tract infection (10%), diarrhea (8%), COVID-19 (6%), and anemia and fatigue (5% each)2
- ARs that led to dose reduction occurred in 35% of patients2
- The most frequent (≥5%) ARs leading to dose reductions of TRODELVY included neutropenia (15%), diarrhea (8%), and fatigue (6%)2
AEs leading to treatment discontinuation were lower with TRODELVY and pembrolizumab vs chemotherapy and pembrolizumab (12% vs 31%)4
Most common (≥20%) adverse reactions and lab abnormalities in ASCENT-04
- The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache and increased eosinophils (26% each), and decreased albumin (25%)2
ILD is not listed as a warning and there are no specific recommendations for monitoring for ILD in the TRODELVY USPI.2
Adverse reactions in ≥10% of patients with mTNBC in ASCENT-032
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| ADVERSE REACTIONa | TRODELVY (n=275) | Treatment of Physician’s Choice* (n=276) |
|---|---|---|
| Gastrointestinal Disorders | All Grades (%)Grade 3–4 (%) | All Grades (%)Grade 3–4 (%) |
| Nausea | 611.8 | 340.4 |
| Diarrheab | 5510 | 200.7 |
| Constipation | 380 | 250 |
| Vomiting | 251.8 | 131.4 |
| Abdominal painb | 240.7 | 120 |
| Stomatitisb | 191.1 | 90.4 |
| Skin and Subcutaneous Tissue Disorders | ||
| Alopecia | 550 | 270 |
| Rashb | 200.4 | 180.4 |
| Pruritus | 100 | 60 |
| General Disorders and Administration Site Conditions | ||
| Fatigueb | 473.3 | 474.0 |
| Edemab | 110.4 | 110 |
| Pyrexiab | 111.1 | 100.7 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Coughb | 180 | 130.4 |
| Metabolism and Nutrition Disorders | ||
| Decreased appetite | 170.7 | 100.4 |
| Nervous System Disorders | ||
| Headacheb | 170.4 | 120 |
| Peripheral neuropathyb | 120 | 310.4 |
| Infections and Infestations | ||
| Upper respiratory tract infectionb | 160.4 | 90 |
| Urinary tract infectionb | 100.7 | 150.7 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgiab | 150 | 170.4 |
| Back pain | 110.4 | 80.4 |
*Treatment of Physician’s Choice included gemcitabine/carboplatin (n=122), nab-paclitaxel (n=110), and paclitaxel (n=44).
aGraded per NCI CTCAE v5.0.
bIncludes other related terms.
Adverse reactions in ≥10% of patients with mTNBC in ASCENT-042
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| ADVERSE REACTIONSa | TRODELVY + pembrolizumab (n=221) | Treatment of Physician's Choice* + pembrolizumab (n=220) |
|---|---|---|
| Gastrointestinal Disorders | All Grades (%)Grade 3–4, (%) | All Grades (%)Grade 3–4, (%) |
| Diarrheab | 7212 | 302.7 |
| Nausea | 683.2 | 381.8 |
| Constipation | 410.5 | 350.5 |
| Vomiting | 290.9 | 141.8 |
| Abdominal painb | 260.5 | 150 |
| Stomatitisb | 180.5 | 160 |
| General Disorders and Administration Site Conditions | ||
| Fatigueb | 588 | 563.2 |
| Edemab | 160.5 | 170.5 |
| Pyrexiab | 120.9 | 120.5 |
| Skin and Subcutaneous Tissue Disorders | ||
| Alopecia | 520 | 320 |
| Rashb | 371.4 | 331.8 |
| Pruritus | 140.5 | 120.9 |
| Nervous System Disorders | ||
| Headacheb | 260.5 | 180 |
| Peripheral neuropathyb | 130.9 | 394.5 |
| Dizzinessb | 120 | 100 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgiab | 190.9 | 240.5 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Coughb | 190.5 | 200 |
| Metabolism and Nutrition Disorders | ||
| Decreased appetite | 181.8 | 140 |
| Hypothyroidismb | 110.5 | 180 |
| Infections and Infestations | ||
| Upper respiratory tract infectionb | 180 | 130 |
| Urinary tract infectionb | 161.4 | 160.5 |
| COVID-19 | 100.5 | 70.5 |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | ||
| Breast painb | 100 | 90 |
| Investigations | ||
| Weight decreased | 100 | 50.5 |
*Treatment of Physician’s Choice included gemcitabine/carboplatin (n=107), nab-paclitaxel (n=68), and paclitaxel (n=45).
aGraded per NCI CTCAE v5.0.
bIncludes other related terms.
For recommendations for management of adverse reactions of pembrolizumab, refer to the pembrolizumab Prescribing Information.
Laboratory abnormalities in >10% of patients with mTNBC in ASCENT-032
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| LABORATORY ABNORMALITY | TRODELVY (n=275) All Grades % (Grade 3–4, %) |
Treatment of Physician's Choice (n=276) All Grades % (Grade 3–4, %) |
|---|---|---|
| HEMATOLOGY | ||
| Decreased neutrophil count | 84 (47) | 80 (43) |
| Decreased leukocyte count | 80 (29) | 80 (33) |
| Decreased hemoglobin | 78 (7) | 81 (19) |
| Decreased lymphocyte count | 47 (16) | 53 (19) |
| Decreased platelet count | 18 (6) | 40 (17) |
| CHEMISTRY | ||
| Increased glucose | 52 (0) | 44 (0) |
| Increased alanine aminotransferase |
39 (4.0) | 56 (6) |
| Increased alkaline phosphatase | 38 (1.1) | 35 (0) |
| Increased lactate dehydrogenase |
35 (0) | 35 (0) |
| Increased aspartate aminotransferase |
31 (2.2) | 47 (2.5) |
| Decreased potassium | 28 (5) | 18 (2.5) |
| Decreased albumin | 23 (2.5) | 14 (0.4) |
| Decreased magnesium | 19 (2.9) | 25 (0.7) |
| Decreased sodium | 18 (1.5) | 15 (1.1) |
| Increased phosphate | 16 (0) | 9 (0) |
| Increased potassium | 16 (0.7) | 18 (0.7) |
| Increased magnesium | 14 (5) | 11 (1.8) |
| Hypoglycemia | 14 (1.1) | 9 (0) |
| Decreased phosphate | 12 (0) | 10 (0) |
| Increased urate | 12 (0) | 4 (0) |
Laboratory abnormalities in >10% of patients with mTNBC in ASCENT-042
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| LABORATORY ABNORMALITY | TRODELVY + pembrolizumab (n=221) All Grades % (Grade 3–4, %) |
Treatment of Physician's Choice + pembrolizumab (n=220) All Grades % (Grade 3–4, %) |
|---|---|---|
| HEMATOLOGY | ||
| Decreased neutrophil count | 86 (50) | 86 (47) |
| Decreased hemoglobin | 86 (10) | 88 (18) |
| Decreased leukocytes count | 84 (32) | 83 (31) |
| Decreased lymphocyte count | 61 (21) | 60 (19) |
| Increased eosinophils | 26 (0) | 17 (0) |
| Decreased platelet count | 16 (5) | 43 (17) |
| CHEMISTRY | ||
| Increased alkaline phosphate | 50 (0.9) | 33 (1.8) | Increased glucose | 50 (0) | 47 (0) |
| Increased alanine aminotransferase |
47 (4.1) | 55 (8) |
| Increased aspartate aminotransferase |
40 (3.7) | 51 (4.1) |
| Decreased potassium | 35 (4.6) | 24 (2.3) |
| Increased lactate dehydrogenase |
34 (0) | 37 (0) |
| Decreased albumin | 25 (0.9) | 14 (0.9) |
| Decreased sodium | 20 (1.4) | 20 (3.2) |
| Increased urate | 19 (0) | 7 (0) |
| Increased magnesium | 17 (6) | 13 (3.7) |
| Increased phosphate | 17 (0) | 12 (0) |
| Decreased magnesium | 16 (1.4) | 21 (0) |
| Increased thyroid stimulating hormone |
15 (0) | 24 (0) |
| Decreased phosphate | 14 (0) | 9 (0) |
| Increased blood bilirubin | 12 (3.7) | 8 (3.2) |
| Increased sodium | 12 (0.5) | 2.3 (0.5) |
| Decreased glucose | 11 (0) | 15 (1.4) |
| Increased potassium | 11 (0.9) | 9 (0.9) |
No new safety signals were observed when compared to the previously established TRODELVY safety profile2
Review clinical data, including real-world outcomes, in patients with mTNBC who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease
1L=first line; ADC=antibody-drug conjugate; AE=adverse event; AR=adverse reaction; AUC=area under the curve; BICR=blinded independent central review; BRCA1/2=breast cancer genes 1 and 2; CI=confidence interval; CPS=combined positive score; CR=complete response; DFI=disease-free interval; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FDA=Food and Drug Administration; G-CSF=granulocyte colony-stimulating factor; HR=hazard ratio; IHC=immunohistochemistry; ILD=interstitial lung disease; ITT=intent-to-treat; mDOR=median duration of response; mPFS=median progression-free survival; mTNBC=metastatic triple-negative breast cancer; NCCN=National Comprehensive Cancer Network; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; ORR=objective response rate; OS=overall survival; PARPi=poly (ADP-ribose) polymerase inhibitor; PD-1=programmed cell death protein 1; PD-L1=programmed death ligand 1; PD-(L)1=PD-1 or PD-L1; PD-(L)1i=PD-1 or PD-L1 inhibitor; PFS=progression-free survival; PR=partial response; PV=pathogenic variant; QOL=quality of life; RECIST=Response Evaluation Criteria in Solid Tumors; TEAE=treatment-emergent adverse event; TNBC=triple-negative breast cancer; TPC=treatment of physician's choice; TTR=time to response; USPI=United States Prescribing Information.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 8, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 3. Cortés J, Punie K, Barrios SA, et al. Sacituzumab govitecan in untreated, advanced triple-negative breast cancer. N Engl J Med. 2025;393(19):1912-1925. 4. Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer. N Engl J Med. 2026;394(4):354-366. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed March 6, 2026. To view the most recent and complete version of this guideline, go online to NCCN.org. 6. Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer: supplementary appendix. N Engl J Med. 2026;394:354-366.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
- As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later
- For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information
Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.
Boxed Warning: neutropenia and diarrhea
- TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
- TRODELVY can cause severe diarrhea. 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 as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% 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 (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients 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: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, 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. 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 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% 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 of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
Drug Interactions
UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. 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.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
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