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Monday, September 5, 2022

New Data in HR+/HER2- Metastatic Breast Cancer Shows Progression-Free Survival Benefit of Trodelvy

 Progression-Free Survival Efficacy of Trodelvy Consistent with That Observed in the TROPiCS-02 Intention-to-Treat Population --

-- Results Presented at ESMO 2022 Highlight Trodelvy as a Potential Treatment Option in HR+/HER2-Low and IHC0 Status Metastatic Breast Cancer --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from a post hoc subgroup analysis from the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy) versus comparator chemotherapies (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies. The analysis examined progression-free survival (PFS) in the intention-to-treat population by HER2-immunohistochemistry (IHC) status, and the results demonstrated that Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups.

Summary of results:

HER2-low

IHC0

ITT

Trodelvy arm
(n=149)

TPC arm
(n=134)

Trodelvy arm
(n=101)

TPC arm
(n=116)

Trodelvy arm
(n=272)

TPC arm
(n=271)

Median PFS
(months)

6.4

4.2

5.0

3.4

5.5

4.0

Hazard ratio
(95% confidence
interval)
p-value

0.58
(0.42-0.79)

0.72
(0.51-1.00)

0.66
(0.53 – 0.83)
p=0.0003

Detailed findings will be presented at a mini-oral session (Abstract #1362) during the European Society for Medical Oncology (ESMO) Congress 2022 in the Évry Auditorium, Paris Expo Porte de Versailles, on September 10.

https://finance.yahoo.com/news/tropics-02-data-hr-her2-220500157.html

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