SACI-IO HR+: a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
A C Garrido-Castro, S E Kim, T Li et al.
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In 30 seconds
This randomized phase II trial evaluated the efficacy of sacituzumab govitecan (SG) with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. Among 104 patients, the combination did not significantly improve progression-free survival (PFS) compared to SG alone, with median PFS of 8.4 months versus 6.7 months (hazard ratio 0.76, P = 0.12).
Key findings
- Median PFS was 8.4 months for SG plus pembrolizumab versus 6.7 months for SG alone (HzR 0.76, P = 0.12).
- Median overall survival was 20.0 months for SG plus pembrolizumab compared to 18.0 months for SG (P = 0.18).
- In the PD-L1-positive population, median PFS was 11.1 months for the combination versus 5.6 months for SG alone (HzR 0.51, P = 0.09).
- The most common grade ≥2 adverse events included neutropenia, alopecia, and fatigue.
Why it matters
Understanding the efficacy of combination therapies in metastatic breast cancer is crucial for optimizing treatment strategies. This study highlights the need for further investigation into the role of pembrolizumab in specific patient populations, particularly those with PD-L1 expression.