NCCN Elevates Sacituzumab Govitecan-Hziy to Preferred Recommendations in Metastatic Breast Cancer


Sacituzumab govitecan-hziy is now a category 1 preferred recommendation in triple-negative breast cancer and a category 2A preferred recommendation in HR-positive/HER2-negative disease.

The National Comprehensive Cancer Network (NCCN) has updated its guidelines regarding use of sacituzumab govitecan-hziy (Trodelvy) in triple-negative breast cancer (TNBC) and hormone receptor (HR)–positive/HER2-negative metastatic breast cancer. The Trop-2 directed antibody-drug conjugate (ADC) is now a category 1 preferred recommendation in TNBC and a category 2A preferred recommendation in HR-positive/HER2-negative disease.1

Category 1 is the NCCN’s highest recommendation, indicating that there is uniform NCCN consensus that the intervention is appropriate. A category 2A recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate, but the guideline is based on lower-level evidence.

“Sacituzumab govitecan continues to offer significant benefit for appropriate patients with metastatic TNBC in need of second-line options, and the NCCN’s category 1 recommendation, the highest designation from the organization, further supports sacituzumab govitecan as a preferred therapeutic option for this patient population,” Bill Grossman, MD, PhD, senior vice president, therapeutic area head, Gilead Oncology, said in a news release. “Additionally, the category 2A recommendation for patients with HR-positive/HER2-negative advanced breast cancer exhibits sacituzumab govitecan’s broad potential across tumor types.”

The NCCN based its TNBC decision on data from a final analysis of the phase 3 ASCENT trial (NCT02574455) presented at the 2022 ASCO Annual Meeting. Sacituzumab govitecan induced a median overall survival (OS) of 11.8 months vs 6.9 months with standard chemotherapy (HR, 0.51; P <.0001) among patients with relapsed or refractory metastatic TNBC who received 2 or more prior systemic therapies, at least 1 for metastatic disease.2

The ADC also demonstrated a 59% reduction in the risk of disease progression or death, extending median progression-free survival (PFS) to 4.8 months compared with 1.7 months with chemotherapy (HR, 0.41; P <.0001).

Sequential single-agent chemotherapy is the standard of care for endocrine therapy–resistant disease. For some patients, however, these treatments are associated with increased toxicity and declining response rates, disease control, and quality of life. There are few chemotherapy options in later lines and there remains a high unmet clinical need for heavily pretreated patients with HR-positive/HER2-negative metastatic breast cancer.

The NCCN looked to the phase 3 TROPiCS-02 trial (NCT03901339) presented at the 2022 ASCO Annual Meeting for its recommendation in HR-positive/HER2-negative disease. At a median follow-up of 10.2 months, the median PFS was 5.5 months (95% CI, 4.2-7.0) with sacituzumab govitecan vs 4.0 months (95% CI, 3.1-4.4) with investigator’s choice chemotherapy (HR, 0.66; 95% CI, 0.53-0.83; P = .0003).3

The OS data were not mature at the time of the primary analysis; however, investigators noted a numeric trend toward improvement with the ADC vs standard care. At 6 months, 46% of patients who received sacituzumab govitecan (n = 272) were alive without worsening disease compared with 30% who received chemotherapy (n = 271). At 1-year, 21% of patients in the experimental group were progression-free compared with 7% assigned to chemotherapy.

Furthermore, improvements in PFS associated with sacituzumab govitecan were consistent across predefined subgroups including patients with more than 3 prior chemotherapy regimens in the metastatic setting, those with visceral metastases, and patients aged 65 years or older. Investigators also observed an improvement in fatigue and global health status/quality of life by EORTC QLQ-C30.


  1. Sacituzumab govitecan-hziy (Trodelvy) elevated to category 1 preferred recommendation in second-line metastatic triple-negative breast cancer and added as a category 2a preferred recommendation for HR+/HER2- metastatic breast cancer in NCCN clinical practice guidelines in oncology (NCCN Guidelines). Gilead Sciences. August 3, 2022. Accessed August 9, 2022.
  2. Khalid F, Kashyap R, Singh V, et al. Efficacy of sacituzumab govitecan based regimen in triple-negative breast cancer: a systematic review. J Clin Oncol. 2022;40(suppl 16):e13068. doi:10.1200/JCO.2022.40.16_suppl.e13068
  3. Rugo HS, Bardia A, Marmé F, et al. Primary results from TROPiCS-02: a randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. J Clin Oncol. 2022;40(suppl 17):LBA1001. doi:10.1200/JCO.2022.40.17_suppl.LBA1001
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