A recent phase 3 trial has shown that adding nivolumab to standard neoadjuvant chemotherapy significantly improves pathological complete response (pCR) rates in high-risk estrogen receptor-positive (ER+), HER2-negative breast cancer. Conducted between November 2019 and April 2022, this study involved 510 patients across 31 countries.
The trial compared the effectiveness of chemotherapy combined with nivolumab versus a placebo in newly diagnosed patients. Results demonstrated a pCR rate of 24.5% in the nivolumab group, compared to 13.8% in the placebo group. Particularly, patients with PD-L1-positive tumors showed a higher benefit, with pCR rates of 44.3% versus 20.2% in the placebo group. The study reported no unexpected safety issues, although two deaths in the nivolumab group were linked to drug toxicity.
Breast cancer remains a significant global health concern, with ER+/HER2-negative subtypes posing unique challenges due to their heterogeneity. Traditional treatments include chemotherapy and endocrine therapies, but the addition of immunotherapy could mark a paradigm shift. Previous studies, like the KEYNOTE-756, have shown similar trends with pembrolizumab, highlighting the potential of immune checkpoint inhibitors in improving treatment outcomes.
Experts suggest that the trial’s findings could redefine treatment protocols by incorporating immunotherapy for better management of ER+/HER2-negative breast cancer. The results underscore the importance of identifying biomarkers like PD-L1 expression and stromal tumor-infiltrating lymphocytes to tailor treatments effectively.
This groundbreaking trial suggests that nivolumab in combination with chemotherapy could set new standards for treating high-risk ER+/HER2-negative breast cancer. Future research will focus on long-term outcomes and further biomarker analysis to refine patient stratification and optimize therapeutic strategies.
Article Source: Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial | Nature Medicine
Image Credit: Photo by National Cancer Institute on Unsplash
