Trojan horses encapsulated by a TRODELVYᵀᴹ cell membrane in a green, cellular environment.

Trial Design

Efficacy and safety were evaluated in patients who were heavily pretreated

TRODELVY was studied in an open-label, uncontrolled, single-arm phase 1/2 trial (N=108)1


≥2 prior
therapies for

Blue arrow

IV dose of
10 mg/kg
Days 1 and 8,
every 21 days

Blue arrow

Until disease
progression or
intolerance to

Median treatment duration was 5.1 months (range: 0-51 months)

Major efficacy outcome measures were investigator-assessed overall response rate (ORR) using RECIST 1.1 and duration of response

  • Additional outcome measures included: time to response, progression-free survival, and overall survival (OS)1

Demographics and patient characteristics (N=108)

male, n
 Median age,
years (range)
 ECOG status Race1
107/1 55 (31-80) 0     29% White 76%
  Age <65    87% 1     71% Black 7%
      Asian 3%
      Other 14%
male, n
Median age,
years (range)
55 (31-80)
Age <65    87%
ECOG status
0     29%
1     71%
White 76%
Black 7%
Asian 3%
Other 14%
  • 76% of patients had visceral disease, 42% had hepatic metastases, 56% had lung/pleura metastases, and 2% had brain metastases
  • 12 patients (11%) had Stage IV disease at the time of initial diagnosis

Key eligibility criteria for the trial included: age ≥18 years, Eastern Cooperative Oncology Group (ECOG) status of 0-1, ≥2 prior therapies in metastatic setting and refractory to or relapsed after ≥1 prior standard therapeutic regimen, prior taxane therapy, and measurable disease by CT or MRI.2 Patients with bulky disease, defined as a mass >7 cm, were not eligible. Patients with treated brain metastases not receiving high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks were eligible. Patients with Gilbert’s disease were excluded.

Patients received a median of 3 prior therapies (range: 2, 10)

  • 40% of patients received 2 prior therapies3
  • 60% of patients received ≥3 prior therapies3

Prior chemotherapies included:

Percentage of prior chemotherapies used by patients in order from most common to least; Taxanes (98%)—Ixabepilone (8%)

Prior chemotherapies included:

Percentage of prior chemotherapies used by patients in order from most common to least; Taxanes (98%)—Ixabepilone (8%)
  • 17% of patients received a checkpoint inhibitor (including pembrolizumab) in a prior investigational setting1
References: 1. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380(8):741-751. 2. Bardia A, Mayer IA, Diamond JR, et al. Efficacy and safety of anti-Trop-2 antibody drug conjugate sacituzumab govitecan (IMMU-132) in heavily pretreated patients with metastatic triple-negative breast cancer. J Clin Oncol. 2017;35(19):2141-2148. 3. Data on file.