Trodelvy® (sacituzumab govitecan-hziy)

Laboratory Evaluation of Trop-2 Expression Prior to Use

This document is in response to your request for information regarding Trodelvy® (sacituzumab govitecan-hziy [SG]) and laboratory evaluation of trophoblast cell surface antigen 2 (Trop-2) expression prior to usage.

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:

www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Summary

Relevant Product Labeling1

There is no requirement described or recommendation regarding the evaluation of Trop-2 expression contained in the SG US FDA-approved prescribing information.

Clinical Data

Trop-2 expression confirmation, via immunohistology or other means, was not required prior to treatment in the SG clinical studies (ASCENT in patients with metastatic triple‑negative breast cancer [mTNBC],2 TROPiCS-02 in patients with hormone receptor positive/human epidermal growth factor receptor 2-negative metastatic breast cancer [HR+/HER2- mBC],3  and IMMU-132-01 in patients with metastatic epithelial cancers4). However, biopsy, surgical, or tumor specimens were collected during the ASCENT and TROPiCS-02 studies.5,6

Additional Information

Gilead Sciences does not provide information regarding evaluation of Trop-2 expression offered by any commercial laboratory and is unable to provide recommendations or suggestions pertaining to the use of any commercial laboratory for testing.

Clinical Data

In ASCENT and TROPiCS-02, Trop-2 expression level was classified by a histological score (H-score), which was determined by the percentage of cells with specific staining intensity (staining intensity multiplied by proportion of cells with Trop-2 staining; scale, 0-300). Tumor samples were collected at study entry to determine membrane Trop-2 expression using an immunohistochemistry (IHC) assay.5,7

ASCENT Study in mTNBC

ASCENT, a global, open‑label, randomized, phase 3 study (N=529) investigated the efficacy and safety of SG 10 mg/kg on Days 1 and 8 of a 21 day cycle (n=267) vs treatment of physician’s choice (TPC [n=262; eribulin, vinorelbine, gemcitabine, or capecitabine]) in patients with refractory or relapsed mTNBC who had received ≥2 prior chemotherapies for unresectable, locally advanced, or metastatic disease.2

Primary or metastatic archival biopsy or surgical specimens were requested at study entry to determine tumor Trop-2 expression; however, confirmation of Trop-2 expression was not required for study participation. Trop-2 expression was evaluated in patients who were negative for brain metastasis (BMNeg, n=468) using a validated IHC assay and was categorized by H-score; in this population, 290 patients had Trop-2 expression data available (SG; n=151, TPC; n=139. Table 1). No data were collected on Trop-2 expression in primary vs metastatic tumors.5

Table 1. ASCENT: Trop-2 Expression in BMNeg Population5

aSeven and four patients in the SG and TPC groups, respectively, had no Trop-2 expression.

TROPiCS-02 Study in HR+/HER2- mBC

TROPiCS-02, a phase 3 open-label, randomized, multicenter study investigated the safety and efficacy of SG 10 mg/kg IV on Days 1 and 8 of a 21 day cycle (n=272) with TPC (eribulin, gemcitabine, capecitabine, or vinorelbine; n=271) in 543 patients with HR+/HER2- mBC who received ≥2 and ≤4 prior chemotherapy regimens for metastatic disease, including ≥1 endocrine therapy, taxane and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy in any setting.3

Primary or metastatic archival tumor tissue was requested at study entry to determine tumor Trop-2 expression; however, confirmation of Trop-2 expression was not required for study participation. Membrane Trop-2 expression was assessed by a validated research IHC assay and data were categorized by H-score (H-score <100 and ≥100). The H-score <100 group was further divided into H-score ≤10 and >10 to <100 subgroups. In this exploratory analysis, 238 patients (88%) in the SG group, and 224 patients (83%) in the TPC group had samples evaluable for Trop-2 expression (Table 2). Trop-2 expression was observed in ~95% of patients with evaluable samples; 25 patients (5%) had a H-score of 0 (SG; n=10).7

Table 2. TROPiCS-02: Trop-2 Expression in Tumor Tissue Samples7

IMMU-132-01 Study in Metastatic Epithelial Cancer4

A phase 1/2, single-arm, open-label basket study investigated the efficacy and safety of SG as an IV infusion on Days 1 and 8 of a 21-day treatment cycle in patients with metastatic epithelial cancers (including patients with mTNBC and HR+/HER2- mBC) who had relapsed after or were refractory to ≥1 prior therapy for metastatic disease. During the dose escalation phase of this study, SG was administered at doses of 8 (n=81), 10 (n=402), 12 (n=9), or 18 (n=3) mg/kg.

Trop-2 expression confirmation was not required, and patients were permitted to enroll regardless of the levels of Trop-2 expression.

References

1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.

2. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541.

3. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376.

4. Bardia A, Messersmith WA, Kio EA, et al. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. Ann Oncol. 2021;32(6):746-756.

5. Bardia A, Tolaney SM, Punie K, et al. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. Ann Oncol. 2021;32(9):1148-1156.

6. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer [Protocol]. J Clin Oncol. 2022;40(29):3365-3376.

7. Rugo H, Bardia A, Marme F. Sacituzumab Govitecan vs Treatment of Physician's Choice: Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients With HR+/HER2- Metastatic Breast Cancer. Presented at: 2022 SABCS; December 6-10; San Antonio, TX. 2022.

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Follow-Up

For any additional questions, please contact Trodelvy Medical Information at:

☎1‐888-983-4668 or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

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