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

Trial Design

TRODELVY RESPONDS TO THE UNMET NEED FOR PHASE 3 SURVIVAL DATA IN PRETREATED mTNBC

ASCENT was a landmark, phase 3, randomized, open-label, active-controlled trial (N=529) that studied the use of TRODELVY vs single-agent chemotherapy1

Patients with brain metastases were allowed to enroll up to a predefined maximum of 15% of patients in the ASCENT trial; magnetic resonance imaging (MRI) to determine brain metastases was required prior to enrollment for patients with known or suspected brain metastases. Patients with known Gilbert’s disease or bone-only disease were excluded.1
*All patients received previous taxane treatment in either the adjuvant, neoadjuvant, or advanced stage unless there was a contraindication or intolerance to taxanes during or at the end of the first taxane cycle.1

Single-agent chemotherapy comparator arm (n=262)1

PATIENT DEMOGRAPHICS AND BASELINE CHARACTERISTICS

Demographics and baseline characteristics in the full population1

  • Median age of 54 years (range: 27–82 years); 81% <65 years
  • 99.6% female
  • 79% White; 12% Black/African American
  • 29% of patients had received prior PD-1/PD-L1 therapy
  • Patients included 42% with hepatic metastases (visceral disease), 12% with brain metastases, and 9% with BRCA1/BRCA2 mutational status positive
  • ECOG performance status of 0 (43%) or 1 (57%)

~1 out of 8 patients (13%) of the full population in the TRODELVY group received only 1 prior line of systemic therapy in the metastatic setting.* Efficacy results in this subgroup were consistent with those who received at least 2 prior lines in the metastatic setting.1

*In addition to having disease recurrence or progression within 12 months of neoadjuvant/adjuvant systemic therapy.

88% of patients in the full population were BM-negative1

  • 12% had baseline brain metastases previously treated and stable (n=61; 32 on TRODELVY arm and 29 on single-agent chemotherapy arm)

The primary analysis was in the BM-neg population (TRODELVY, n=235, and single-agent chemotherapy, n=233)2

Primary endpoint1

  • Median PFS in BM-neg population by BICR based on RECIST 1.1 criteria

Select secondary endpoints1,2

  • Median PFS in the full population
  • Median OS in both the BM-neg and full populations
  • Objective Response Rate (ORR)
BICR=blinded, independent, central review; mTNBC=metastatic triple-negative breast cancer; PD-1=programmed death receptor; PD-L1=programmed death-ligand 1; RECIST=Response Evaluation Criteria in Solid Tumors.
References: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; April 2021. 2. Data on file. Gilead Sciences, Inc. 2021.