Trodelvy® (sacituzumab govitecan-hziy)
Real-World Data in mTNBC
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Trodelvy® (sacituzumab govitecan-hziy)
Real-World Data in mTNBC
Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.
The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Relevant Product Labeling1
SG is indicated for the treatment of adult patients with unresectable locally advanced or mTNBC who have received ≥2 prior systemic therapies, ≥1 of them for metastatic disease.
Real-World Data on SG Use in mTNBC
This document summarizes real‑world evidence on SG in mTNBC from multiple studies, focusing on patient characteristics, line of therapy (LOT), efficacy, and safety. It is not intended to be comprehensive; additional real-world evidence summaries are available for specific topics, including antibody-drug conjugate sequencing, use in Asian patients, and neutropenia incidence and management.
Summaries of real-world studies that evaluated SG use in patients with mTNBC are shown in Table 1.2-21
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Table 1. Real-World Studies of Patients With mTNBC2-21
Region and Data Source | Pt Characteristics | SG Setting/ | Effectiveness Outcomes | Safety Outcomes |
Retrospective cohort database study2 England; Cancer Analysis System database (data sources: Systemic Anti‑Cancer Therapy database, Cancer Outcomes and Services Dataset, and Office of National Statistics) | N=980; female, 100% 2L cohort (n=606)
3L cohort (n=374)
| SG LOT: 3L, n=374 3L was composed of two subcohorts: 3La (Stage I or II, or resectable Stage III TNBC) and 3Lm (unresectable Stage III or de novo Stage IV TNBC) | mPFS (95% CI), mo: 2L, 2.53 (2.3–2.76) 3L, 2.43 (2.2–2.76) mOS (95% CI), mo: 2L, 6.7 (6.14–7.62) 3L, 5.54 (4.9–6.14) Results are available for 3L subcohorts | Safety data not reported |
Retrospective, observational, multicenter study3,4 Canada; pt support program | N=453
| SG LOT: 2L, 29.4% 3L, 42.8% 4L, 16.6% 5L+, 11.3% | Treatment duration, median (95% CI), mo: 4.2 (3.7–4.9) Effectiveness data not reported | Treatment modifications:
SG DCs (including DCs due to AEs), n (%): Pt decision, 12 (3.7); |
Retrospective study5 US; Integra Connect Precision‑Q database | N=409; female, 99.3%
| SG LOT, n (%): 2L, 192 (46.9) 3L, 128 (31.3) 4+, 89 (21.8) SG used in multiple LOTs, 21 (5.1) | Follow-up, median (range), mo: 10 (0.6–51.3) mPFS (95% CI), mo:
mOS (95% CI), mo:
mTTNTD (95% CI), mo: 6 (5.3–6.6) | Most common AEs: fatigue, 47.4%; diarrhea, 38.1%; neutropenia, 34.7%; nausea, 32% Treatment modifications:
Neutropenia, n (%): 281 (68.7); G-CSF use, n (%): 247 (60.4)
|
Retrospective, observational cohort study6 US; Flatiron Health database | N=381; female, 99%
| SG LOT, n (%): 2L, 118 (31) 3L+, 263 (69) | Follow-up, median (IQR), mo: mOS (95% CI), mo:
mTTNTD (95% CI), mo: 5.6 (5–6.4) | Treatment modifications: Dose reductions, n/N (%): 137/308 (44) Neutropenia, n (%):
G-CSF use, n (%):
|
Retrospective cohort study7 Poland/Czech Republic/Slovakia (14 centers) | N=249; female, 100%
| Prior LOTs, median (IQR): 2 (1–2) | Follow-up, median (IQR), mo: Outcome (95% CI), mo: mPFS, 4.1 (2.9–5.3) ORR: 31.4% | Treatment modifications Delays, 60.2% Dose reductions, 41.5% |
Retrospective, observational cohort study8 US; ConcertAI Patient 360™ and physician notes | N=230; female, 100%
| SG LOT: 2L, 33% 3L+, 67% | Follow-up, median: 7.2 mo mOS (95% CI), mo:
mPFS (95% CI) mo:
mTTNTD (95% CI), mo:
| Toxicities: Fatigue, 45%; neutropenia, 33%; and diarrhea, 30% Toxicity led to, n (%): SG DC, 17 (7); G-CSF use, n (%):
Time from SG initiation to G-CSF use (among pts receiving G-CSF during SG use), median (IQR): 8.5 (8–29) d |
Retrospective, observational, SACISUR study9,21 Spain (18 hospitals) | N=159; female, 100%
| Previous LOT, median (range): 3 (2–8) SG LOT: 1L, 3.8% 2L, 41.5% 3L+, 54.1% | Follow-up, median: 11.6 mo Outcome (95% CI), mo: mPFS, 4.6 (3.7–6.3) ORR (CR or PR): 31.2% DCR: 68.9% Results are available for BMPos cohort | Most common AEs (Grade 3/4):
AEs led to:
G-CSF use:
|
Italy (11 centers) | N=149; female, 100%
| Prior anticancer regimens in metastatic setting median (range): 2 (0–7) | Follow-up, median: 18.2 mo Outcome (95% CI) mo: mPFS, 5.75 (4.37–7.13) mOS, 12.8 (10.8–15.9) ORR: 40% (all were PR) | Select TRAEs, any grade (Grade 3/4):
SG dose decreased, 34.9% SG DC, 4% |
Retrospective study12 UK (16 centers) | N=132; female, 99.2%
| Prior LOT in metastatic setting, median: 2 SG LOT: 2L, 28% 3L 31% 3L+, 41% | Survival analysis population, n=126 mPFS (95% CI) mo:
mOS (95% CI), mo:
| Most common AEs, all grade (Grade 3/4):
Treatment modifications due to AEs led to SG DC, 5% |
Retrospective and prospective, observational SARELIFE study13 Italy (30 centers) | N=128; female, 100%
| Prior LOT, median (range): 2 (0–9) 1 or 2 prior LOTs: 67.2% >2 prior LOTs: 32.8% | Follow-up, median: 12.7 mo Outcome (95%CI), mo: mPFS, 5.9 (4.5–6.8) ORR: 31.9% Best response (evaluable, n=116): CR, 0.9%; PR, 31%; | Most common AEs (safety analysis, n=122):
Grade 3 pneumonitis, n=1 Dose reductions, n=46 AEs led to SG DC, n=4 Time to first dose reduction, median (range): 32 (7–205) d |
France (8 centers) | N=127
| Prior LOT in metastatic setting, median (range): 2 (0–11) | Follow-up, median (95% CI), mo: 10.4 (8.3–11.2) Outcome (95% CI), mo: mPFS, 4.1 (3.7–4.7) mOS, 9.7 (7.1–12.2) Best response (n=116): CR, 2.6%; PR, 33.6%; SD ≥6 mo, 39.7%; PD, 24.1% | Safety data not reported |
Retrospective, single-center study16 US; Memorial Sloan Kettering Cancer Center | N=126; female, 99%
| Prior LOT in metastatic setting, median (range): 2 (0–8) | Outcomes (range), mo: mPFS, 3 (0–13) | Most common AEs:
AEs led to SG dose reduction, 31% |
Retrospective study17 US (4 centers) | N=115; female, 100%
| Prior LOT in metastatic setting, n (%): ≤3L, 81 (70.4) >3L, 34 (29.6) | Follow-up, median: 16.1 mo mOS (95% CI), mo:
mPFS (95% CI), mo: 4.8 (3.6–5.9) ORR: 27.8% CR, 1%; PR, 26.8%; SD for ≥6 mo, 35%; PD, 37.1% | Most common (≥20%) any grade AEs, (Grade 3/4):
AEs led to, n (%): SG dose reduction, 58 (51.3) SG DC, 15 (13.2) G-CSF use, n (%): After starting SG, 54 (47) Primary support, 26 (22.6) Secondary prophylaxis, 28 (24.3) |
Multicenter TRACIE study18 Australia EAP and reimbursed pts; interim analysis (17 sites) | N=112
| Prior LOT in metastatic setting: ≥2L, 62.5% | Follow-up, median: 25.3 mo Outcome (95% CI), mo: mPFS, 9.5 (8.4–11.5) | Most common AEs:
Toxicities led to:
AEs that led to SG DC: nausea (4.5%); neutropenia (3.6%); and anemia, fatigue, and diarrhea (each, 2.7%). G-CSF use: primary prophylaxis, 7.1%; secondary prophylaxis, 32.1% |
Ambispective, bicentric cohort study19 France EAP | N=103; female, 100%
| Prior LOT in advanced setting, n (%): 1–2L, 66 (64.1) | Follow-up, median: 9.6 mo Outcome (range), mo: mPFS, 4 (3.5–5.3) ORR, n (%): 31 (30.1)
Results available for BMPos pts | Toxicity led to, n/N (%):
Most common toxicities that led to SG dose reduction, n/N (%):
|
Retrospective, observational study: TROPSPAIN20 Spain Cohort 1 (SG in | N=87; female, 100%
| SG LOT: 2L, 26.4% 3L in 24.1% ≥4L in 49.4% Number of prior LOT median (IQR): 2 (1–4). | Interim analysis Follow-up, median (IQR), mo: 9.2 (5.2–15.3) Outcome (95% CI), mo: mOS, 9.3 (7.7–12.3) | AEs of interest, any grade (Grade 3/4): Diarrhea,b 46.7% (5.4%) Neutropenia, 44% (54.9%) Any-grade AE led to, n (%):
G-CSF use for prophylaxis, n/N (%): primary, 14/33 (42.4); secondary, 19/33 (57.6) |
Abbreviations: 1L/2L/3L/4L=first-/second-/third-/fourth-line; 2L+/3L+/4L+/5L+=second-/third-/fourth-/fifth-line or later; AE=adverse event; BC=breast cancer; BMNeg=negative for brain metastases; BMPos=positive for brain metastases; CNS=central nervous system; CR=complete response; DC=discontinuation; DCR=disease control rate; EAP=Early Access Program; ECOG PS=Eastern Cooperative Oncology Group Performance Status; G-CSF=granulocyte colony‑stimulating factor; HR=hazard ratio; LA=locally advanced; LOT=line of therapy; mOS=median overall survival; mPFS=median progression‑free survival; mTNBC=metastatic triple‑negative breast cancer; mTTNTD=median time to next treatment or death; NA=not available; NE=not estimable; NR=not reached; ORR=objective response rate; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PR=partial response; SD=stable disease; pt=patient; SG=sacituzumab govitecan-hziy; TNBC=triple-negative breast cancer; TPC=treatment of physician’s choice; TRAE=treatment-related adverse event.
aECOG PS was missing/unknown at BC diagnosis in 377, 254, 211, and 43 pts in the 2L, 3L combined, 3La, and 3Lm cohorts, respectively; at initiation in 78 and 45 pts in the 2L and 3L combined cohorts; and at initiation of 3L in 394 pts in the 2L cohort.
bGrade was unknown in 2 pts (3.6%) who reported diarrhea.
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Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
References
21. Falcón-González A, Llabrés-Valenti E, Henao-Carrasco F, et al. Real-world effectiveness and safety of Sacituzumab Govitecan in metastatic triple-negative breast cancer: results from the multicenter retrospective observational SACISUR cohort in Southern Spain. Front Oncol. 2026;16:1717135. https://www.ncbi.nlm.nih.gov/pubmed/41815552
Product Label
For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Follow-Up
For any additional questions, please contact Trodelvy Medical Information at:
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https://www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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