Dr Stearns on the Efficacy of Avelumab in TNBC

The only approved agent we have right now is pembrolizumab, but I do continue it in all my patients [with resected TNBC] unless there’s a reason to discontinue it otherwise, until we have studies that give us better predictors [of response].”

Vered Stearns, MD, director, Translational Breast Cancer Research, Weill Cornell Medical School, discusses findings from the phase 3 A-BRAVE trial (NCT02926196) evaluating the efficacy of avelumab (Bavencio), an anti–PD-L1 immune checkpoint inhibitor, as adjuvant therapy in patients with early triple-negative breast cancer (TNBC) at high risk for relapse.

In a presentation at the 42nd Annual Chemotherapy Foundation Symposium (CFS) Symposium, Stearns noted that despite significant advances in TNBC management, high-risk patients with residual disease after neoadjuvant chemotherapy remain at elevated risk for relapse. The A-BRAVE trial addressed this unmet need by assessing whether 1 year of adjuvant avelumab could improve outcomes in this population, as well as in patients at high risk for recurrence after primary surgery and adjuvant chemotherapy. The primary end point was disease-free survival (DFS), with overall survival (OS) serving as a secondary end point.

Oncologists have long questioned whether the presence of the primary tumor is required for patients to achieve benefit with immune checkpoint inhibitor therapy, Stearns says. Results from the A-BRAVE trial demonstrated that treatment with adjuvant avelumab in the absence of the primary tumor did not significantly improve DFS vs observation in patients with high-risk TNBC. However, adjuvant avelumab did significantly improve DFS compared with control. Adjuvant avelumab also significantly improved distant DFS vs observation.

Regarding safety, immune-related adverse effects, including thyroid dysfunction, were observed but were generally manageable and tolerable. Importantly, no new safety signals were identified.

Based on these findings, Stearns continues to use pembrolizumab (Keytruda), the only checkpoint inhibitor that is currently FDA approved for patients with TNBC, in the adjuvant setting barring reasons to discontinue it beyond the absence of the primary tumor.

Stearns emphasizes that although these findings represent progress, further studies are required to determine the optimal integration of avelumab into TNBC treatment paradigms, including potential combination strategies with other immunotherapies or targeted agents. The A-BRAVE trial contributes to the growing body of evidence supporting the use of immune checkpoint inhibitors in TNBC, Stearns concludes.