53 Overall Survival (OS) Results From the Phase 3 TROPiCS-02 Study of Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC) in Patients (pts) With HR+/ HER2− Metastatic Breast Cancer (mBC)

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement40th Annual Miami Breast Cancer Conference® - Abstracts
Volume 37
Issue suppl 4
Pages: 35-36

TABLE. Responses

TABLE. Responses

TABLE. EORTC QLQ-C30 Time to Deterioration Endpoint

TABLE. EORTC QLQ-C30 Time to Deterioration Endpoint

Background

Pts with HR+/HER2– mBC are treated with endocrine-based therapy (ET), followed by single-agent chemotherapy (CT), with increasingly shorter durations of benefit. SG is an anti– Trop2 antibody-drug conjugate approved for triple-negative mBC with ≥2 prior therapies (≥1 in metastatic setting). In TROPiCS-02 (NCT03901339), SG showed significant progression-free survival (PFS) benefit vs TPC in ET-resistant HR+/HER2− mBC (HR, 0.66; P <0.001; median 5.5 vs 4.0 mo). Here, we report the planned TROPiCS-02 OS 2nd interim analysis.

Materials and Methods

Eligible pts with HR+/HER2– mBC who received prior taxane, ET, CDK4/6 inhibitor, and 2-4 prior CTs were randomized 1:1 to receive SG (10 mg/kg IV on d1 and d8, every 21d) or TPC until progression or unacceptable toxicity. The primary end point was PFS by BICR with key secondary end point of OS. Per protocol, OS was analyzed after ~350 events. In the statistical testing hierarchy, objective response rate (ORR) and pt-reported outcomes are tested sequentially if OS is significant.

Results

543 pts were randomized to receive SG (n = 272) vs TPC (n = 271). Pts had a median of 3 prior CTs for mBC, and 95% had visceral metastases. At data cutoff on July 1, 2022 (median follow-up, 12.5 mo), 390 OS events had occurred. SG significantly improved OS (median 14.4 vs 11.2 mo; HR, 0.79; P = .020), ORR, global health status/QoL, and fatigue vs TPC (Table). The safety of SG was consistent with prior reports, with no new safety signals identified.

Conclusions

This was consistent with prior reports, with no new safety signals identified. SG demonstrated a statistically significant and clinically meaningful improvement in OS, and significant improvement in ORR and QoL, vs TPC with manageable safety in pts with ET-resistant HR+/HER2– mBC, a population with limited treatment options. These data reinforce the use of SG as a novel therapy for pts with pretreated HR+/ HER2– mBC.

AFFILIATIONS:

Hope S. Rugo,1 Aditya Bardia,2 Frederik Marmé,3 Javier Cortes,4 Peter Schmid,5 Delphine Loirat,6 Olivier Trédan,7 Eva Ciruelos,8 Florence Dalenc,9 Patricia Gómez Pardo,10 Komal L. Jhaveri,11 Rosemary Delaney,12 Theresa Valdez,12 Hao Wang,12 Wendy Verret,12 Sara M. Tolaney13

1Department of Medicine, University of California-San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.

2Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.

3Medical Faculty Mannheim, Heidelberg University, Department of Obstetrics and Gynaecology, Mannheim, Germany.

4Medical Oncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quirosalud Group, Madrid and Barcelona, Spain, Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain.

5Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.

6Institut Curie, Medical Oncology Department and D3i, Paris, France.

7Medical Oncology Department, Centre Léon Bérard, Lyon, France.

8Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.

9Institut Claudius Régaud, Toulouse, France.

10Hospital Universitari Vall D’Hebron, Barcelona, Spain.

11Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY.

12Gilead Sciences Inc, Foster City, CA.

13Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.

Articles in this issue

1 Elacestrant Versus Fulvestrant or Aromatase Inhibitor in a Phase 3 Trial Evaluating Elacestrant, an Oral Selective Estrogen Receptor Degrader Versus Standard-of- Care Endocrine Monotherapy for ER+/HER2– Advanced/Metastatic Breast Cancer
1 Elacestrant Versus Fulvestrant or Aromatase Inhibitor in a Phase 3 Trial Evaluating Elacestrant, an Oral Selective Estrogen Receptor Degrader Versus Standard-of- Care Endocrine Monotherapy for ER+/HER2– Advanced/Metastatic Breast Cancer
2 Molecular Characterization of HER2-Low Patients Identifies Basal-Enriched Subset With Poor Clinical Outcomes in Real-world Data
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3 Real-world Outcomes of Sacituzumab Govitecan in Metastatic Breast Cancer Patients: A Single Institution Experience
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7 EMERALD Phase 3 Trial of Elacestrant Versus Standard-of- Care Endocrine Therapy in Patients With ER+/HER2– Metastatic Breast Cancer: Updated Results by Duration of Prior CDK4/6i in Metastatic Setting
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12 TIP HARMONIA SOLTI-2101/ AFT-58: A Head-to-Head Phase III Study Comparing Ribociclib (RIB) and Palbociclib (PAL) in Patients (pts) With Hormone Receptor– Positive/HER2-Negative/HER2- Enriched (HR+/HER2−/HER2-E) Advanced Breast Cancer (ABC)
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15 Updated Expert Consensus Recommendations for Managing Hyperglycemia and Rash in Patients With PIK3CA-Mutated, Hormone Receptor–Positive (HR+), Human Epidermal Growth Factor Receptor 2–Negative (HER2–) Advanced Breast Cancer Treated With Alpelisib
16 Primary Results From the Randomized Phase II RIGHT Choice Trial of Premenopausal Patients With Aggressive HR+/HER2− Advanced Breast Cancer Treated With Ribociclib + Endocrine Therapy vs Physician’s Choice Combination Chemotherapy
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17 A Clinical Systematic Literature Review of Treatments Among Patients With Advanced/ Metastatic HER2+ Breast Cancer
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20 TIP ELONA: An Open-Label, Phase 1b-2 Study of Elacestrant, in Combination With Onapristone in Patients With Estrogen Receptor– Positive, Progesterone Receptor– Positive, HER2-Negative Advanced or Metastatic Breast Cancer
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