Sacituzumab Govitecan in Pretreated HR+/HER2- Metastatic Breast Cancer
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
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
#BreastCancer #HRPositive #SacituzumabGovitecan #Trodelvy #CancerResearch #ADC
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