Prescription Drug Information: TRODELVY (Page 5 of 6)
14.2 Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
TROPiCS-02 Study
The efficacy of TRODELVY was evaluated in a multicenter, open label, randomized study (TROPiCS-02; NCT03901339) conducted in 543 patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer whose disease has progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane; patients received at least two prior chemotherapies in the metastatic setting (one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months).
Patients were randomized (1:1) to receive TRODELVY 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21 day cycle (n=272) or 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). Randomization was stratified by the following factors: prior chemotherapy regimens for metastatic disease (2 vs. 3–4), visceral metastasis (Yes or No), and endocrine therapy in the metastatic setting for at least 6 months (Yes or No).
Patients were treated until disease progression or unacceptable toxicity. 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. The primary efficacy outcome measure was PFS as determined by BICR per RECIST v1.1. Additional efficacy measures included OS, ORR by BICR, and DOR by BICR.
The median age of patients in the study population was 56 years (range: 27–86 years), 26% of patients were 65 years or over. The majority of patients were female (99%); 67% were White, 4% were Black and 3% were Asian, and 26% were of unknown race. Patients received a median of 7 (range: 3 to 17) prior systemic regimens in any setting and 3 (range: 0 to 8) prior systemic chemotherapy regimens in the metastatic setting. Approximately 42% of patients had 2 prior chemotherapy regimens for treatment of metastatic disease compared to 58% of patients who had 3 to 4 prior chemotherapy regimens and all patients had an ECOG performance status of 0 (45%) or 1 (55%). Ninety-five percent of patients had visceral metastases. Most patients received endocrine therapy in the metastatic setting for ≥ 6 months (86%).
TRODELVY demonstrated a statistically significant improvement in PFS and OS versus single agent chemotherapy.
The efficacy results are summarized in Table 13 and Figure 3 and Figure 4.
All Randomized Patients | ||
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TRODELVYn=272 | Single Agent Chemotherapyn=271 | |
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Progression-Free Survival by BICR * | ||
Median PFS in months (95% CI) | 5.5(4.2, 7.0) | 4.0(3.1, 4.4) |
Hazard ratio (95% CI) | 0.661 (0.529, 0.826) | |
p-value † | 0.0003 | |
Overall Survival ‡ | ||
Median OS in months (95% CI) | 14.4(13.0, 15.7) | 11.2(10.1, 12.7) |
Hazard ratio (95% CI) | 0.789 (0.646, 0.964) | |
p-value † | 0.0200 | |
Objective Response Rate by BICR | ||
Response Rate, % (95% CI) | 21.0 (16.3, 26.3) | 14.0 (10.1, 18.7) |
Odds ratio (95% CI) | 1.625 (1.034, 2.555) | |
p-value | 0.0348 | |
Duration of Response (DOR) by BICR | ||
Median DOR in months(95% CI) | 8.1 (6.7, 9.1) | 5.6 (3.8, 7.9) |
Figure 3: Kaplan-Meier Plot of PFS by BICR in TROPiCS-02
Figure 4: Kaplan-Meier Plot of OS in TROPiCS-02
14.3 Locally Advanced or Metastatic Urothelial Cancer
TROPHY Study
The efficacy of TRODELVY was evaluated in TROPHY (NCT03547973), an single-arm, multicenter study that enrolled 112 patients with locally advanced or mUC who have received prior treatment with a platinum-containing chemotherapy and either PD-1 or PD-L1 inhibitor. Patients were administered TRODELVY 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day treatment cycle. Prior to the administration of TRODELVY, all patients were treated for prevention of chemotherapy induced nausea, vomiting and infusion reactions. Patients were treated until disease progression or unacceptable toxicity.
The median age was 66 years (range: 33 to 90 years), 78% were male, 74% were White, 3% Asian, 3% Black and 20% unknown. All patients had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (28%) or 1 (72%). Ninety-six percent of patients had metastatic disease; 67% of patients had visceral metastases, including 34% with liver metastases.
The median number of prior systemic therapies was 3 (range: 1 to 8). Sixty-five percent of patients received prior cisplatin, 21% received prior carboplatin, 13% received both prior cisplatin and carboplatin, and 100% received prior PD-1 or PD-L1 inhibitor. For 34% of patients, the platinum-containing chemotherapy was received in the neoadjuvant/adjuvant setting only. Nine percent of patients received prior enfortumab vedotin.
The major efficacy outcome measures were the ORR and DOR, evaluated by Independent Review Assessment, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Table 14 summarizes the efficacy results.
TRODELVY(N=112) | |
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CI confidence interval | |
+ denotes ongoing | |
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Overall Response Rate * | |
ORR (95% CI) | 27.7% (19.6, 36.9) |
Complete response | 5.4% |
Partial response | 22.3% |
Response duration * | |
Number of responders | 31 |
Median, Months (95% CI) | 7.2 (4.7, 8.6) |
Range, Months | 1.4+, 13.7 |
15 REFERENCES
1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
TRODELVY (sacituzumab govitecan-hziy) for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial. Each TRODELVY vial is individually boxed in a carton:
- NDC 55135-132-01 contains one 180 mg vial
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.
TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures1.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information)
Neutropenia
Advise patients of the risk of neutropenia. Instruct patients to immediately contact their healthcare provider if they experience fever, chills, or other signs of infection [see Warnings and Precautions (5.1)].
Diarrhea
Advise patients of the risk of diarrhea. Instruct patients to immediately contact their healthcare provider if they experience diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours [see Warnings and Precautions (5.2)].
Hypersensitivity and Infusion-Related Reactions
Inform patients of the risk of serious infusion reactions and anaphylaxis. Instruct patients to immediately contact their healthcare provider if they experience facial, lip, tongue, or throat swelling, urticaria, difficulty breathing, lightheadedness, dizziness, chills, rigors, wheezing, pruritus, flushing, rash, hypotension, or fever that occur during or within 24 hours following the infusion [see Warnings and Precautions (5.3)].
Nausea/Vomiting
Advise patients of the risk of nausea and vomiting. Premedication according to established guidelines with a two or three drug regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) is also recommended. Additional antiemetics, sedatives, and other supportive measures may also be employed as clinically indicated. All patients should receive take-home medications for preventing and treating delayed nausea and vomiting, with clear instructions. Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting [see Warnings and Precautions (5.4)].
Embryo-Fetal Toxicity
Advise female patients to contact their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].
Contraception
Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of TRODELVY [see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of TRODELVY [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential that TRODELVY may impair fertility [see Use in Specific Populations (8.3)].
Manufactured by:
Gilead Sciences, Inc.
333 Lakeside Dr.
Foster City, CA 94404, USA
The Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 02/2023 | |
Patient Information TRODELVY® (troh-DELL-vee)(sacituzumab govitecan-hziy)for injection, for intravenous use | ||
What is the most important information I should know about TRODELVY?TRODELVY can cause serious side effects, including:
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What is TRODELVY? TRODELVY is a prescription medicine used to treat adults with:
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Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure. | ||
Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you:
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How will I receive TRODELVY?
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What are the possible side effects of TRODELVY? TRODELVY can cause serious side effects, including:
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TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.These are not all of the possible side effects of TRODELVY.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
General information about the safe and effective use of TRODELVY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRODELVY that is written for health professionals. | ||
What are the ingredients in TRODELVY?Active ingredient: sacituzumab govitecan-hziyInactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrateManufactured by: Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404, USAU.S. License No. 2258761115-GS-007For more information about TRODELVY, go to www.TRODELVY.com or call 1-888-983-4668. |
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