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 as a single agent is indicated for the 1L treatment of adult patients with unresectable locally advanced or mTNBC who are not candidates for programmed death-(ligand) 1 inhibitor-based therapy.
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 (N≥150), focusing on patient characteristics, 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 1.2-18
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 mTNBC2-18
Region and Data Source | Pt Characteristics | SG Setting/ | Effectiveness Outcomes | Safety Outcomes |
France; SNDS (health insurance reimbursement and hospitalization data) | N=3653; mTNBC, n=2527; HR+/HER2- mBC, n=1126; female, 99.7%
| Previous anticancer regimens from 6 categories of anticancer regimens,a median (IQR): 1 (1–2)
| Follow-up, median (IQR): 9.4 (5.2–15.5) mo mOS (95% CI):
mTTDb (95% CI):
| SG was DC in 1630 pts (64.5%), and 54 (2.1%) restarted SG after 81 d
No other safety data were reported |
Retrospective review of clinical database4,5 US; breast tumor specimens that underwent profiling and insurance claim database review | Breast tumors, N=4030 SG-only (n=1807)
| SG LOT not reported | Time on treatment
OS
| Safety data were not reported |
Retrospective cohort database study6 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): 2L, 2.53 (2.3–2.76) mo 3L, 2.43 (2.2–2.76) mo mOS (95% CI): 2L, 6.7 (6.14–7.62) mo 3L, 5.54 (4.9–6.14) mo Results are available for 3L subcohorts | Safety data were not reported |
Retrospective, observational, multicenter study7,8 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): 4.2 (3.7–4.9) mo Effectiveness data not reported | Treatment modifications:
DCs (including DCs due to AEs), n (%): Pt decision, 12 (3.7); |
Retrospective study9 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): 10 (0.6–51.3) mo mPFS (95% CI):
mOS (95% CI):
mTTNTD (95% CI): 6 (5.3–6.6) mo | 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 study10 US; Flatiron Health database | N=381; female, 99%
| SG LOT, n (%): 2L, 118 (31) 3L+, 263 (69) | Follow-up, median (IQR): mOS (95% CI):
mTTNTD (95% CI):
| Treatment modifications, n/N (%):
Neutropenia, n (%):
|
Retrospective, single-center study11
US; MD Anderson Cancer Center | N=472; mTNBC and HR+/HER2- mBC
mTNBC cohort, n=354:
| SG LOT, %: 3L+, 21 | Overall follow-up, median: 9.1 mo mTNBC cohort:
| Safety data were not reported |
Retrospective cohort study12 Poland/Czech Republic/Slovakia (18 centers) | N=303; female, 100%
| Prior palliative systemic LOTs, median (IQR): 1 (1–2); | Follow-up, median (IQR): mPFS: 4.37 mo;
mOS: 11.3 mo
ORR: 30.7%; outcomes, n (%):
Multivariable analyses on factors that influenced OS and PFS are available | Most frequent AEs (any-grade/Grade 3/
Treatment modifications, n (%): Delays, 191 (63) Dose reductions, 114 (37.6) |
Retrospective, observational, multicenter study: TROPSPAIN13 Spain (20 sites) | N=288; female, 98.6%
| SG LOT, n (%): 2L, 86 (29.9) 3L, 77 (26.7) 4L+, 125 (43.4) | Follow-up, median (IQR):
Outcome (95% CI):
mOS by LOT (95% CI):
mTTNTD by LOT (95% CI):
| Any AEs: n=241 (83.7%) AESIs, n (%):
Grade, n (%):
AEs led to, n (%):
G-CSF use, n (%):
|
Retrospective multicenter study14 Turkey (52 centers) | N=285; female, 100%
| Previous LOT, median (range): 2 (1–6) SG LOT ,n (%): 2L, 27 (9.4) 3L, 139 (48.7) 4L, 53 (18.6) 5L, 39 (13.7) 6L+, 27 (9.4) | mPFS (95% CI):
mOS (95% CI):
ORR/DCR, %:
BMPos (n=64), 31.3/56.3 | Select TRAEs, any grade (Grade 3 or 4), %:
G-CSF use:
Dose modifications due to AEs, n (%): |
Multicenter observational analysis15 Italy (18 centers) | N=271; n=76 LTRs (defined as PFS ≥9 mo; included n=60 [78.9%] 9–18 mo and n=16 [21.1%] ≥18 mo)
| SG LOT, n (%): 1L, 3 (3.9) 2L, 26 (34.2) ≥3L, 47 (61.8)
| Follow-up, median: 19.4 mo Outcome (95% CI): mPFS, 14 (13.3–16.7) mo mOS, 25.6 (21–NR) mo ORR, 67.1%
mPFS by LOT (95% CI): 2L vs 3L+: 6.7 (5–8.4) vs 6.2 (4.7–7.3) mo (P=0.28) | Safety data were not reported |
Retrospective, observational cohort study16 US; ConcertAI Patient 360™ and physician notes | N=230; female, 100%
Metastatic sites, n (%): | SG LOT, %: 2L, 33 3L+, 67 | Follow-up, median: 7.2 mo mOS (95% CI):
mPFS (95% CI):
mTTNTD (95% CI):
| Toxicities, %: Fatigue, 45; neutropenia, 33; and diarrhea, 30 Toxicity led to, n (%):
G-CSF use, n (%):
|
Retrospective, observational, SACISUR study17,18 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): mPFS, 4.6 (3.7–6.3) mo ORR (CR or PR): 31.2% DCR: 68.9% Results are available for BMPos cohort | Most common AEs (Grade 3 or 4), %:
AEs led to, %:
G-CSF use, %: Primary/secondary prophylaxis, 29.6/17.6 |
aCategories included the following: capecitabine, anti-PD-(L)1, hormone therapy (aromatase inhibitors or anti-estrogens), poly adenosine phosphate ribose polymerase inhibitors; cyclin-dependent 4/6 inhibitors; and trastuzumab deruxtecan. The median values were calculated in pts with ≥1 prior treatment.
bDefined as first occurrence of SG discontinuation (no redosing of SG within 21 d + 60 d washout period, even if SG was restarted later), death, or study end.
cECOG 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.
dOf the 3 pts who died, 2 events were due to neutropenia. One of these events was considered treatment related, and the patient was not treated with G‑CSF. The third death was due to pulmonary embolism.
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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
Abbreviations
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1L/2L/3L/4L=first-/second-/
third-/fourth-line
2L+/3L+/4L+/5L+/6L+=
second-/third-/fourth-/fifth-/
sixth-line or later
AE=adverse event
AESI=adverse event of special interest
BC=breast cancer
BMPos=positive for brain metastases
CNS=central nervous system
CR=complete response
DC=discontinuation
DCR=disease control rate
ECOG PS=Eastern Cooperative Oncology Group Performance Status
G-CSF=granulocyte colony‑stimulating factor
HER2=human epidermal growth factor receptor 2
HR=hazard ratio
HR-/+=hormone receptor-negative/positive
LOT=line of therapy
LTR=long-term responder
mBC=metastatic breast cancer
mOS=median overall survival
mPFS=median progression‑free survival
mTNBC=metastatic triple‑negative breast cancer
mTTD=median time to treatment discontinuation
mTTNT=median time to next treatment
mTTNTD=median time to next treatment or death
NE=not estimable
NR=not reached
ORR=objective response rate
OS=overall survival
PD=progressive disease
PFS=progression-free survival
PR=partial response
pt(s)=patient(s)
SD=stable disease
SG=sacituzumab govitecan‑hziy
SNDS=Systéme National des Données de Santé (French National Health Data System)
TNBC=triple‑negative breast cancer
TRAE=treatment-related adverse event
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
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:
☎1‐888-983-4668 or www.askgileadmedical.com
Adverse Event Reporting
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
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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