Drug Trial Snapshot: TRODELVY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the  TRODELVY Package Insert for complete information.

TRODELVY (sacituzumab govitecan-hziy)
(troh-DELL-vee)
Immunomedics, Inc.
Approval date: April 22, 2020

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DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

TRODELVY is a drug for the treatment of adults with triple-negative breast cancer that has spread to other parts of the body (metastatic). It should be used in patients who have received at least two prior therapies for their metastatic disease.

Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2 (HER2) protein.

How is this drug used?

TRODELVY is an injection. It is given directly into the vein (intravenous infusion) by a healthcare provider once weekly on Days 1 and 8 of 21-day treatment cycles.

What are the benefits of this drug?

The trial measured the percent of patients whose tumors completely or partially shrank after treatment (objective response rate). In the trial, approximately 30 percent of 108 patients taking TRODELVY experienced complete or partial shrinkage of their tumors that lasted about 8 months.

TRODELVY was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

What are the benefits of this drug (results of trials used to assess efficacy)?

Table 1 shows efficacy results based on investigator assessed overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. and duration of response.

Table 1. Efficacy Results

	TRODELVY  (N=108)
Overall Response Rate i
ORR (95% CI)	33.3% (24.6, 43.1)
Complete response	2.8%
Partial response	30.6%
Response duration i
Number of responders	36
Median, Months (95% CI)	7.7 (4.9, 10.8)
Range, Months	1.9+, 30.4+
% with duration ≥ 6 months	55.6%
% with duration ≥ 12 months	16.7%

ⁱ investigator assessment
CI: confidence interval+: denotes ongoing

TRODELVY Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: Almost all included patients were women, therefore sex differences could not be determined.
• Race: The majority of patients were White, therefore race differences could not be determined.
• Age: TRODELVY worked similarly in patients above and below 65 years of age.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

Table 2 shows the efficacy results by race and age. Sex subgroup was not analyzed because all but one patient were females.

Table 2. Exploratory Efficacy Subgroup Analyses

Demographic Group	N	# Responders	Confirmed ORR (95% CI)
Race
White	82	27	32.9% (22.9, 44.2)
Black or African American	8	3	37.5% (8.5, 75.5)
Other	18	6	33.3% (13.3, 59.0)
Age Group
<65 years	89	29	32.6% (23.0, 43.3)
≥65 years	19	7	36.8% (16.3, 61.6)

Adapted from FDA Review

What are the possible side effects?

TRODELVY may cause serious side effects including low white cell blood count (neutropenia), severe diarrhea, life-threatening allergic reactions, nausea and vomiting.

The most common side effects of TRODELVY are nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, hair loss, constipation, rash, decreased appetite, and abdominal pain.

What are the possible side effects (results of trials used to assess safety)?

Table 3 below summarizes common adverse reactions.

Table 3. Adverse Reactions in ≥10% in Patients with mTNBC

Adverse Reaction	TRODELVY (n=108)
	Grade 1-4 (%)	Grade 3-4 (%)
Any adverse reaction	100	71
Gastrointestinal disorders	95	21
Nausea	69	6
Diarrhea	63	9
Vomiting	49	6
Constipation	34	1
Abdominal paini	26	1
Mucositisii	14	1
General disorders and administration site conditions	77	9
Fatigueiii	57	8
Edemaiv	19	0
Pyrexia	14	0
Blood and lymphatic system disorders	74	37
Neutropenia	64	43
Anemia	52	12
Thrombocytopenia	14	3
Metabolism and nutrition disorders	68	22
Decreased appetite	30	1
Hyperglycemia	24	4
Hypomagnesemia	21	1
Hypokalemia	19	2
Hypophosphatemia	16	9
Dehydration	13	5
Skin and subcutaneous tissue disorders	63	4
Alopecia	38	0
Rashv	31	3
Pruritus	17	0
Dry Skin	15	0
Nervous system disorders	56	4
Headache	23	1
Dizziness	22	0
Neuropathyvi	24	0
Dysgeusia	11	0
Infections and infestations	55	12
Urinary Tract Infection	21	3
Respiratory Infectionvii	26	3
Musculoskeletal and connective tissue disorders	54	1
Back pain	23	0
Arthralgia	17	0
Pain in extremity	11	0
Respiratory, thoracic and mediastinal disorders	54	5
Coughviii	22	0
Dyspneaix	21	3
Psychiatric disorders	26	1
Insomnia	13	0

Graded per NCI CTCAE v. 4.0
ⁱ Including abdominal pain, distention, pain (upper), discomfort, tenderness
ⁱⁱ Including stomatitis, esophagitis, and mucosal inflammation
ⁱⁱⁱ Including fatigue and asthenia
^iv Including edema; and peripheral, localized, and periorbital edema
^v Including rash; maculopapular, erythematous, generalized rash; dermatitis acneiform; skin disorder, irritation, and exfoliation
^vi Including gait disturbance, hypoesthesia, muscular weakness, paresthesia, peripheral and sensory neuropathy
^vii Including lower and upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis and respiratory syncytial virus infection
^viii Includes cough and productive cough
^ix Includes dyspnea and exertional dyspnea

TRODELVY Prescribing Information

Were there any differences in side effects among sex, race and age?

• Sex: Almost all included patients were women; therefore, sex differences could not be determined.
• Race: The majority of patients were White; therefore, race differences could not be determined.
• Age: The occurrence of overall side effects was similar in patients above and below 65 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

Analysis of side effects by race and age subgroups is presented below. Sex analysis was not conducted because all but one patient were females.

Table 4. Summary of Treatment-Emergent Adverse Events (TEAEs) by Race

Adverse Event	TRODELVY N = 108
	White N=82	Black N=8	Asian N=3	Other N=15
Any TEAEs, n (%)	82 (100)	8 (100)	3 (100)	15 (100)
Grade 3-4, n (%)	61 (74)	6 (75)	2 (67)	11 (73)
SAEs, n (%)	28 (34)	3 (38)	0	6 (40)

Table 5. Summary of Treatment-Emergent Adverse Events (TEAEs) by Age

Adverse Event	TRODELVY N = 108
	≤65y N=94	>65y N=14
Any TEAEs, n (%)	94 (100)	14 (100)
Grade 3-4, n (%)	68 (72)	12 (86)
SAEs, n (%)	34 (36)	3 (21)

SAEs=serious adverse events

Clinical Trial Report

 

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved TRODELVY based on evidence from one clinical trial (NCT01631552) of 108 patients with triple-negative metastatic breast cancer. The trial was conducted at 10 sites in the United States.

Figure 1 summarizes by sex how many patients were in the clinical trial.

Figure 1. Baseline Demographics by Sex

Adapted from FDA Review

Figure 2 summarizes patients by race in the clinical trial.

Figure 2. Baseline Demographics by Race

*includes American Indian or Alaska Native and Other

Adapted from FDA Review

Figure 3 summarizes patients by age in the clinical trial.

Figure 3. Baseline Demographics by Age

Adapted from FDA Review

Figure 4 summarizes patients by ethnicity in the clinical trial

Figure 4. Baseline Demographics by Ethnicity

Adapted from FDA Review

Who participated in the trials?

The demographic characteristics of the trial population are summarized in Table 6.

Table 6. Demographic Characteristics

Demographic Parameter	TRODELVY N=108 n (%)
Sex
Men	1 (0.9)
Women	107 (99.1)
Race
White	82 (75.9)
Black or African American	8 (7.4)
Asian	3 (2.8)
American Indian or Alaska Native	1 (0.9)
Other	14 (13)
Age
Mean years (SD)	54.2 (10.3)
Median (years)	55
Min, max (years)	31, 80
Age Group
< 65 years	89 (82.4)
≥ 65 years	19 (17.6)
Ethnicity
Hispanic or Latino	7 (6.5)
Not Hispanic or Latino	100 (92.6)
Unknown	1 (0.9)
Region
United States	108 (100)

SD=standard deviation
Adapted from FDA Review

How were the trials designed?

There was one trial that provided data for TRODELVY approval. The trial enrolled adult patients with metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments for their metastatic disease.

Patients received TRODELVY intravenously on Days 1 and 8 of a 21-day treatment cycle. The treatment continued until the disease progressed or the side effects became too toxic.

The trial measured the percent of patients whose tumors completely or partially shrank during the treatment and how long that shrinkage lasted (duration of response).

How were the trials designed?

There was one multicenter, single-arm, trial that enrolled patients with metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments for metastatic disease.

Patients received TRODELVY 10 mg/kg intravenously on Days 1 and 8 of a 21-day treatment cycle. Tumor imaging was obtained every 8 weeks, and treatment continued until disease progression or intolerance to the therapy.

Major efficacy outcome measures were investigator assessed ORR using RECIST 1.1 and duration of response.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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