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William J. Gradishar, MD, FACP, FASCO


ASCO 2024: Adjuvant Use of Avelumab in High Risk, Early-Stage Triple-Negative Breast Cancer

By: Victoria Kuhr, MS
Posted: Wednesday, June 19, 2024

The A-BRAVE phase III, multicentric, randomized adjuvant study found that 1 year of adjuvant use of the PD-L1 inhibitor avelumab vs observation did not significantly improve disease-free survival in patients at with high-risk triple-negative breast cancer. Nevertheless, Pier Franco Conte, MD, of the University of Padua, Italy, and colleagues reported that overall survival (a secondary study endpoint) was significantly improved with avelumab. These findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA500).

The study enrolled patients at a high risk of relapse from triple-negative breast cancer after they completed standard treatment with curative intent, including surgery and neoadjuvant/adjuvant chemotherapy. High-risk patients were defined as having: (1) invasive residual disease (breast and/or nodes) after neoadjuvant chemotherapy (stratum A); and (2) > pN2/any pT, pN1/pT2, or pN0/pT3 after primary surgery (stratum B). Patients were randomly assigned to intravenous avelumab at 10 mg/kg once every 2 weeks for 1 year or observation.

From June 2016 to October 2020, a total of 477 patients were included in the study from 64 Italian and 6 U.K. centers. A total of 378 patients (83%) entered stratum A, of whom 99 (57 avelumab, 42 control) received chemotherapy after surgery prior to study enrollment. Of the total population, 68.3% treated with avelumab and 63.4% treated with the control achieved 3-year disease-free survival (P > .50). In stratum A, the disease-free survival rate after 3 years was similar in patients treated with avelumab and the control group (P > .05; 66.9% and 61.0%, respectively). Of the total population, 85.2% treated with avelumab and 78.2% treated with the control achieved 3-year overall survival (P < .05). In stratum A, the overall survival after 3 years was similar in patients treated with avelumab and the control (P > .05; 83.1% and 76.6%, respectively).

Disclosure: For full disclosures of the study authors, visit

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