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TRODELVY®

sacituzumab govitecan-hziy

180 mg for injection

Continue watching for Important Safety Information at the end of this video.

Please see link provided for full Prescribing Information, including BOXED WARNING.

TRODELVY® in pretreated HR+/HER2- mBC

HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; mBC=metastatic breast cancer.

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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 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

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 patient 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.

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Continue watching for Important Safety Information at the end of this video.

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DR. BRUFSKY: While a range of therapies are available—endocrine-based therapy, CDK4/6 inhibitors, and single-agent chemotherapy—we also know that hormone receptor–positive, HER2-negative metastatic breast cancer is a heterogeneous disease that could become more difficult to treat as patients move through lines of therapy.

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Dr. Adam Brufsky

Medical Oncologist

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DR. BRUFSKY: Significant unmet needs remain when choosing what’s next after multiple lines of therapy.

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Unmet needs remain^1-3

when choosing what’s next

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DR. BRUFSKY: With TRODELVY, also known as sacituzumab govitecan-hziy, physicians can now offer another treatment to pretreated patients who are left with limited options.

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TROPiCS-02 was a Phase 3, randomized, active-controlled, open-label trial^4-6

Treatment was continued until progression or unacceptable toxicity†

Unresectable locally advanced or metastatic HR+/HER2- breast cancer* (N=543) that progressed after:

≥1 endocrine therapy, CDK4/6i, and taxane in any setting ([neo]adjuvant or metastatic)

2−4 lines of chemotherapy for metastatic disease

(Neo)adjuvant therapy for early-stage disease qualified as a prior line of chemotherapy if disease recurred within 12 months

Measurable disease by RECIST 1.1^†

1:1 randomization

TRODELVY 10 mg/kg IV Days 1 and 8, every 21 days (n=272)

Single-agent chemotherapy (n=271)

Single-agent chemotherapy was determined by the investigator before randomization from one of the following choices: eribulin (n=130), vinorelbine (n=63), gemcitabine (n=56), or capecitabine (n=22).

Stratification:

Visceral metastasis (yes/no)

Endocrine therapy in metastatic setting ≥6 months (yes/no)

Prior lines of chemotherapy for metastatic disease (2 vs 3/4)

ENDPOINTS

Primary

PFS by BICR based on RECIST 1.1 criteria

Secondary

OS

ORR and DOR, both by BICR

PRO

Safety

*Disease histology based on the ASCO/CAP criteria.⁵

^†Administration of TRODELVY was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit.⁴

ASCO=American Society of Clinical Oncology; BICR=blinded independent central review; CAP=College of American Pathologists; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; DOR=duration of response; IV=intravenous; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PRO=patient-reported outcomes; RECIST=Response Evaluation Criteria in Solid Tumors.

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DR. BRUFSKY: The efficacy and safety of TRODELVY was studied in TROPiCS-02, a randomized, active-controlled, open-label, Phase 3 trial, which enrolled patients with hormone receptor-positive/HER2- metastatic breast cancer, who have progressed on or after at least 1 endocrine therapy, taxane, and CDK4/6 inhibitor in any setting, and at least 2, but not more than 4, lines of chemotherapy in the metastatic setting.

As a reminder, patients who are HER2- are considered to have an IHC stain of zero, 1+, or 2+ with a negative in situ hybridization.

The primary endpoint of TROPiCS-02 was progression-free survival per RECIST 1.1, as assessed by blinded independent central review for TRODELVY compared with investigator’s choice of chemotherapy, eribulin, vinorelbine, gemcitabine, or capecitabine. Secondary endpoints included overall survival, objective response rate, duration of response.

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Kaplan-Meier estimates of PFS by BICR based on RECIST 1.1 criteria (ITT population)^4,6*

3x more patients on TRODELVY remained progression free and alive at 12 months

TRODELVY

5.5 months

(95% CI: 4.2–7.0)

Single-agent chemotherapy

4.0 months

(95% CI: 3.1–4.4)

HR: 0.66

(95% CI: 0.53–0.83)

P=0.0003

In a prespecified, descriptive analysis, the 12-month PFS rate was 21% with TRODELVY (95% Cl: 15-28) vs 7% with single-agent chemotherapy (95% Cl: 3-14). Not powered for statistical analysis.⁶

*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 occurred first.⁴

CI=confidence interval; HR=hazard ratio; ITT=intent-to-treat.

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DR. BRUFSKY: In TROPiCS-02, TRODELVY provided a statistically significant and clinically meaningful progression-free survival benefit with a median progression-free survival of 5.5 months with TRODELVY versus 4.0 months with single-agent chemotherapy. About 1 in 5 TRODELVY patients remained progression free at 12 months. Not powered for statistical analysis.

DR. BRUFSKY: In terms of overall survival, patients who were taking TRODELVY had 3.2 more months of survival versus single-agent chemotherapy. Patients taking TRODELVY had a median overall survival of 14.4 months, versus 11.2 months, with single-agent chemotherapy.

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Kaplan-Meier estimates of OS (ITT population)^4,6,7

61% of patients on TRODELVY were alive at 12 months

TRODELVY

14.4 months

(95% CI: 13.0–15.7)

Single-agent chemotherapy

11.2 months

(95% CI: 10.1–12.7)

HR: 0.79

(95% CI: 0.65–0.96)

P=0.02

In a prespecified, descriptive analysis, 12-month OS rate was 61% with TRODELVY (95% Cl: 55-66) vs 47% with single-agent chemotherapy (95% Cl: 41-53). Not powered for statistical analysis.⁷

EORTC QLQ-C30 TTD in global health status/QoL, fatigue, and pain⁸

Global health status/QoL

TRODELVY median TTD,

4.3 months

(95% CI: 3.1–5.7)

n=234

Global health status/QoL

Single-agent chemotherapy median TTD,

3.0 months

(95% CI: 2.2–3.9)

n=207

HR: 0.75 (95% CI: 0.61–0.92)

Favors TRODELVY

P value

0.006

Fatigue

TRODELVY median TTD,

2.2 months

(95% CI: 1.6–2.8)

n=234

Fatigue

Single-agent chemotherapy median TTD,

1.4 months

(95% CI: 1.1–1.9)

n=205

HR: 0.73 (95% CI: 0.60–0.89)

Favors TRODELVY

P value

0.002

Pain

TRODELVY median TTD,

3.8 months

(95% CI: 2.8–5.0)

n=229

Pain

Single-agent chemotherapy median TTD,

3.5 months

(95% CI: 2.8–5.0)

n=202

HR: 0.92 (95% CI: 0.75–1.13)

P value

0.415, not significant

TTD of global health status/QoL, fatigue, and pain were prespecified secondary endpoints in the statistical hierarchy^5*†

HRQoL-evaluable patients included those in the ITT population who completed the EORTC QLQ-C30 at baseline and at least 1 postbaseline visit, with HRQoL assessed at baseline, Day 1 of each treatment cycle from Cycle 2, EOT visit, and at the long-term follow-up visit. Baseline mean QoL scores were comparable between both study arms.^5,8

Limitation: EORTC QLQ-C30 is not all inclusive and does not include adequate assessment of additional expected treatment-related symptoms or overall side effect bother from the patient perspective. Results should be interpreted with caution due to the open-label design of the study and because time to deterioration (TTD) may be confounded by events not related to disease/treatment.

*TTD was defined as the time from randomization to the first date a patient achieved ≥10-point deterioration from baseline or died due to any cause, whichever occurred first.⁵

†Patients who had not experienced 10-point deterioration at the time of analysis were censored on the last nonmissing assessment date. Patients without baseline or postbaseline patient-reported outcome assessments were censored at the randomization date.⁵

EORTC QLQ=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EOT=end of treatment; HRQoL=health-related quality of life; QoL=quality of life.

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DR. BRUFSKY: TROPiCS-02 assessed aspects of patients’ health-related quality of life through the EORTC QLQ-C30 questionnaire.

With regard to fatigue, the time to deterioration was 2.2 months with TRODELVY compared with 1.4 months with single-agent chemotherapy.

With regard to pain, the time to deterioration was 3.8 months with TRODELVY compared with 3.5 months with single-agent chemotherapy. This data was not statistically significant.

The results should be interpreted with caution due to the open-label design of the study and because time to deterioration can be confounded by non–disease-, non–treatment-related events. Although the EORTC QLQ-C30 is a reasonable instrument to assess multiple domains of health-related quality of life, this instrument is not all inclusive and does not include adequate assessment of additional expected treatment-related symptoms.

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[table]

Adverse reactions in 10% of patients with HR+/HER2- mBC in TROPiCS-02⁴

Serious adverse reactions in >1% of patients receiving TRODELVY included diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%).⁴

Other clinically significant adverse reactions (≤10%) in TROPiCS-02 included hypotension (5%), pain (5%), rhinorrhea (5%), hypocalcemia (3%), nasal congestion (3%), skin hyperpigmentation (3%), colitis or neutropenic colitis (2%), hyponatremia (2%), pneumonia (2%), proteinuria (1%), and enteritis (0.4%).⁴

Graded per NCI CTCAE v.5.0.⁴

^aSingle-agent chemotherapy included one of the following single agents: eribulin (n=130), vinorelbine (n=63), gemcitabine (n=56), or capecitabine (n=22).^{4 b}Including dyspepsia and gastroesophageal reflux disease⁴. ^cIncluding fatigue and asthenia.^{4 d}Including dyspnea; dyspnea exertional.¹

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

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DR. BRUFSKY: The safety profile is consistent with the findings of previous trials comparing TRODELVY with single-agent chemotherapy.

Serious adverse reactions occurred in 28% of patients taking TRODELVY.

Serious adverse reactions in greater than 1% of patients receiving TRODELVY included diarrhea in 5%, febrile neutropenia in 4%, neutropenia in 3%, abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting, all at roughly 2%.

DR. BRUFSKY: Consider these data as you think about your treatment for patients with pretreated hormone receptor–positive/HER2-negative metastatic breast cancer. TRODELVY could be your next opportunity to delay disease progression and extend survival for your patients

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TRODELVY could be your next opportunity to delay disease progression and extend survival for your appropriate patients.^4,7

Please stay tuned for Important Safety Information for TRODELVY.

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You have the potential to extend survival

Choose TRODELVY in pretreated HR+/HER2- mBC^4,6

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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 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

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 49% 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 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: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. 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: TRODELVY is emetogenic and can cause severe 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 TROPiCS-02 study, the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

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 link provided for full Prescribing Information, including BOXED WARNING.

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References: 1. Schrijver WAME, Schuurman K, van Rossum A, et al. Loss of steroid hormone receptors is common in malignant pleural and peritoneal effusions of breast cancer patients treated with endocrine therapy. Oncotarget. 2017;8(33):55550-55561. 2. Swallow E, Zhang J, Thomason D, Tan R-D, Kageleiry A, Signorovitch J. Real-world patterns of endocrine therapy for metastatic hormone-receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) breast cancer patients in the United States: 2002–2012. Curr Med Res Opin. 2014;30(8):1537-1545. 3. Rugo HS, Dieras V, Cortes J, et al. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1. Breast Cancer Res Treat. 2020;184(1):161-172. 4. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 5. Immunomedics, Inc. Phase 3 study of sacituzumab govitecan (IMMU-132) versus treatment of physician’s choice (TPC) in subjects with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer (MBC) who have failed at least two prior chemotherapy regimens. Published December 21, 2018. Accessed July 22, 2024. https://ascopubs.org/doi/suppl/10.1200/ JCO.22.01002/suppl_file/protocol_JCO.22.01002.pdf 6. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376. 7. Rugo HS, Bardia A, Marmé F, et al. Overall survival results from the phase 3 TROPiCS-02 study of sacituzumab govitecan vs treatment of physician’s choice in patients with HR+/HER2- metastatic breast cancer. Presented at: European Society for Medical Oncology Congress; September 9-13, 2022; Paris, France. Presentation LBA76. 8. Rugo HS, Schmid P, Tolaney SM, et al. Health-related quality of life (HRQoL) in the phase 3 TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (mBC). Presented at: European Society for Medical Oncology Congress; September 9-13, 2022; Paris, France. Presentation 1553O.

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TRODELVY®

sacituzumab govitecan-hziy

180 mg for injection

GILEAD Oncology

TRODELVY, the TRODELVY logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

© 2025 Gilead Sciences, Inc. All rights reserved. US-TROP-2028 07/25

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