Clinical Report: FDA Approves New First-Line TNBC Regimen

Overview

The FDA has approved pembrolizumab and its combination with sacituzumab govitecan-hziy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in patients with PD-L1 expression. This approval is based on the KEYNOTE-D19/ASCENT-04 trial.

Background

Triple-negative breast cancer (TNBC) is characterized by the absence of estrogen, progesterone, and HER2 receptors, leading to limited treatment options. The combination of immunotherapy and antibody-drug conjugates is a new approach in the management of mTNBC.

Data Highlights

Key Findings

• The FDA approved pembrolizumab and its combination with sacituzumab govitecan-hziy for first-line treatment of PD-L1-positive mTNBC.
• The KEYNOTE-D19/ASCENT-04 trial enrolled 443 patients and demonstrated a 35% reduction in the risk of disease progression or death with the new regimen.
• Median progression-free survival was significantly longer with pembrolizumab plus sacituzumab govitecan-hziy (11.2 months) compared to chemotherapy (7.8 months).
• The objective response rate was 61% for the combination therapy versus 55% for chemotherapy.
• Common adverse reactions included decreased neutrophil count, diarrhea, and fatigue, with serious adverse reactions occurring in 38% of patients.

Clinical Implications

The approval of pembrolizumab in combination with sacituzumab govitecan-hziy provides a new first-line treatment option for patients with PD-L1-positive mTNBC.

Conclusion

This combination therapy has been approved for the treatment of patients with advanced triple-negative breast cancer.

Related Resources & Content

1. Merck, FDA, 2026 -- FDA Approves New First-Line TNBC Regimen
2. The ASCO Post — FDA Approves Sacituzumab Govitecan-hziy as Monotherapy and in Combination With Pembrolizumab for First-Line Treatment of TNBC
3. The ASCO Post — NCCN Clinical Practice Guidelines in Oncology: 2024 Updates
4. The ASCO Post — FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
5. dana-farber — Dana-Farber Research Supports FDA Approval of T-DXd Plus Pertuzumab for First-Line Treatment of HER2+ Metastatic Breast Cancer
6. FDA Approves Sacituzumab Govitecan-hziy as Monotherapy and in Combination With Pembrolizumab for First-Line Treatment of TNBC
7. NCCN Clinical Practice Guidelines in Oncology: 2024 Updates
8. FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer | FDA
9. Trodelvy® Added as Preferred Regimen Within First-Line Metastatic Triple-Negative Breast Cancer in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
10. Sacituzumab Govitecan With Pembrolizumab Extends Progression-Free Survival 2 for Some People With Metastatic Triple-Negative Breast Cancer - ASCO