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

Results

For adult patients with unresectable locally advanced or mTNBC who have received 2 or more prior systemic therapies, at least one of them for metastatic disease, TRODELVY demonstrated

3X LONGER MEDIAN PFS VS SINGLE-AGENT CHEMOTHERAPY

  • Single-agent chemotherapy included eribulin (n=139), capecitabine (n=33), gemcitabine (n=38), and vinorelbine (n=52)

88% of patients in the full population were BM-neg,1 and PFS and OS results were statistically significant across both the BM-neg and full populations2

Primary endpoint:
Kaplan-Meier estimates
of median PFS by BICR
based on RECIST 1.1 criteria
(BM-neg population)2*

*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 comes first.

In the full population, TRODELVY demonstrated statistically significant median PFS results vs single-agent chemotherapy1

  • Median PFS was 4.8 months for TRODELVY (range: 4.1–5.8) (n=267) vs 1.7 months with single-agent chemotherapy (range: 1.5–2.5) (n=262); 95% CI, HR: 0.43 (0.35–0.54) P<.0001

Exploratory findings in previously treated, stable BM-positive patients1

  • Median PFS was 2.8 months for TRODELVY (range: 1.5–3.9) vs 1.6 months with single-agent chemotherapy (range: 1.3–2.9); 95% CI, HR: 0.65 (0.35–1.22)

MEDIAN OS OF 1 YEAR WITH TRODELVY

Statistically significant results were demonstrated vs patients treated with single-agent chemotherapy across both the BM-neg and full populations

Secondary endpoint:
Kaplan-Meier plot of
median OS
(BM-neg population)2

In the full population, TRODELVY demonstrated statistically significant improvement in median OS vs single-agent chemotherapy1

  • Median OS was 11.8 months for TRODELVY (range: 10.5–13.8) (n=267) vs 6.9 months with single-agent chemotherapy (range: 5.9–7.6) (n=262); 95% CI, HR: 0.51 (0.41–0.62) P<.0001

Exploratory findings in previously treated, stable BM-positive patients1

  • Median OS was 6.8 months for TRODELVY (range: 4.7–14.1) vs 7.4 months with single-agent chemotherapy (range: 4.7–11.1); 95% CI, HR: 0.87 (0.47–1.63)

ORR OF TRODELVY VS SINGLE-AGENT CHEMOTHERAPY

Secondary endpoint:
Objective Response Rate (ORR)
for TRODELVY vs single-agent chemotherapy (BM-neg population)2

Limitation: This secondary endpoint was not powered for statistical analysis and should be considered descriptive only. Therefore, the results require cautious interpretation and could represent chance findings.

Results for ORR in the full population2

  • 31.1% with TRODELVY (n=267) vs 4.2% with single-agent chemotherapy (n=262), OR: 10.99 (5.66–21.36) P<.0001
    • CR: 3.7% TRODELVY vs 0.8% single-agent chemotherapy
    • PR: 27.3% TRODELVY vs 3.4% single-agent chemotherapy

BICR=blinded, independent, central review; BM-neg=brain metastases negative; CI=confidence interval; CR=Complete Response; HR=hazard ratio; ITT=intention to treat; mTNBC=metastatic triple-negative breast cancer; OR=odds ratio; OS=Overall Survival; PD-L1=programmed death-ligand 1; PFS=Progression-Free Survival; PR=Partial Response; 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.