Sacituzumab Govitecan in Pretreated HR+/HER2- Metastatic Breast Cancer

On September 14, 2020, Kevin Kalinsky and colleagues published the final results of the IMMU-132 Phase 1/2 clinical trial in Annals of Oncology. The study evaluated the efficacy and safety of Sacituzumab govitecan (Trodelvy), an anti-TROP2 antibody-drug conjugate (ADC), in patients with heavily pretreated HR+/HER2- metastatic breast cancer.

Study Design: IMMU-132 Trial

This single-arm basket trial included 54 patients with hormone receptor-positive (HR+) and HER2-negative metastatic breast cancer who had received at least two prior lines of therapy. Patients received Sacituzumab govitecan at a dose of 10 mg/kg.

The primary endpoint was safety, while secondary endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

Key Efficacy Results (Median Follow-up 11.5 Months)

• Objective Response Rate (ORR): 31.5%
• Median Duration of Response (DOR): 8.7 months
• Median Progression-Free Survival (PFS): 5.5 months
• Median Overall Survival (OS): 12.0 months

Safety Profile

The most common Grade 3 or higher adverse events were:

• Neutropenia: 50.0%
• Anemia: 11.1%
• Diarrhea: 7.4%

Only two patients discontinued treatment due to adverse events, and no treatment-related deaths occurred.

Conclusion

The authors concluded that Sacituzumab govitecan monotherapy demonstrates significant antitumor activity with manageable toxicity in patients with heavily pretreated HR+/HER2- metastatic breast cancer. This efficacy is being further confirmed in the ongoing Phase 3 TROPiCS-02 trial.

Source: Annals of Oncology - Sacituzumab Govitecan Phase 1/2 Results

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