Nivolumab Added to Chemo Improves Response in ER+, HER2− Breast Cancer
By Elana Gotkine HealthDay Reporter
THURSDAY, Feb. 6, 2025 -- For patients with high-risk, early-stage estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer (BC), adding nivolumab to neoadjuvant chemotherapy increases pathological complete response (pCR) rates, according to a study published online Jan. 21 in Nature Medicine.
Sherene Loi, M.B.B.S., Ph.D., from the Peter MacCallum Cancer Centre in Melbourne, Australia, and colleagues examined the benefit of adding nivolumab to neoadjuvant chemotherapy in patients with newly diagnosed, high-risk, grade 3 or 2 (ER 1 to ≤10 percent) ER-positive/HER2-negative primary BC in a randomized, multicenter, phase 3 trial involving 510 patients. Participants were randomly allocated to receive anthracycline and taxane-based chemotherapy with either intravenous nivolumab or placebo.
The researchers found that compared with placebo, the nivolumab arm had a significantly higher primary end point of pCR (24.5 versus 13.8 percent), with greater benefit seen for those with programmed death ligand 1-positive tumors (44.3 versus 20.2 percent). No new safety signals were identified. Five deaths occurred in the nivolumab arm, two of which were related to study drug toxicity, while there were no deaths reported in the placebo arm.
"We hope that these results inform treatment decisions and, in turn, improve outcomes for patients with breast cancer, ultimately improving cure rates," coauthor Heather McArthur, M.D., M.P.H., from the University of Texas Southwestern Medical Center in Dallas, said in a statement.
Several authors disclosed ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures nivolumab and funded the study.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
Odds of Advanced Cancer, Breast Cancer Death Lower in Screen-Detected Disease
THURSDAY, June 5, 2025 -- For patients aged 40 years or older, screen-detected breast cancer is associated with lower odds of advanced cancer, mastectomy, and breast...
Nodal Irradiation Does Not Reduce Recurrence, Death for ypN0 Breast Cancer
THURSDAY, June 5, 2025 -- For patients with node-positive breast cancer who become pathologically tumor-free with negative axillary nodes (ypN0) after neoadjuvant chemotherapy...
ASCO: Vepdegestrant Ups Survival in ER+, HER2− Advanced Breast Cancer With ESR1 Mutations
MONDAY, June 2, 2025 -- For patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, the oral...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.