Dr Stearns on the Efficacy of Avelumab in TNBC 

“The PEARLY study helps us as we move forward with this regimen, knowing that carboplatin added to anthracycline/taxane [regimens enhances] disease-free and overall survival benefit [for] patients with triple-negative breast cancer.”

Vered Stearns, MD, director, Translational Breast Cancer Research, Weill Cornell Medical School, discusses the role of carboplatin in early-stage triple-negative breast cancer (TNBC) according to results from the phase 3 PEARLY trial (NCT02441933).

In reference to her presentation at the 

, Stearns explained that, despite being viewed as a standard of care and improving response rates when added to neoadjuvant therapy, the survival benefit with platinum-based chemotherapy agents in the early-stage setting remains inconclusive. She also noted that the precise role of carboplatin remains unclear.

The PEARLY study aimed to address this by evaluating whether carboplatin provides additional benefit when combined with anthracycline/taxane-based therapy vs anthracycline/taxanes alone as either neoadjuvant or adjuvant treatment in early-stage TNBC. After a median follow-up of 51.1 months, patients who received carboplatin in combination with the chemotherapy regimen had significantly improved event-free survival (EFS) compared with those who received standard chemotherapy alone (HR, 0.68; 95% CI, 0.50-0.93; 

 = 0.017). The 5-year EFS rate for the carboplatin arm was 81.9%, a 7.5% improvement over the control group’s rate of 74.4%.

A subgroup analysis revealed consistent benefits across various patient categories, further strengthening the evidence that carboplatin offers a survival advantage. Secondary end points, including invasive disease-free survival and distant recurrence-free survival, also favored the carboplatin-containing regimen.

The PEARLY study provides robust evidence that adding carboplatin to anthracycline and taxane-based therapy enhances survival benefits, positioning it as an effective treatment option for this patient population, Stearns summarizes. These findings reinforce the role of carboplatin in improving survival outcomes for patients with early-stage TNBC, she concludes.

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Vered Stearns, MD, discusses the role of carboplatin in early-stage triple-negative breast cancer according to results from the phase 3 PEARLY trial.

Dr Stearns on the Role of Carboplatin in Early-Stage 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.

, 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.

Vered Stearns, MD, discusses the efficacy of avelumab as adjuvant therapy in patients with early triple-negative breast cancer.

Vered Stearns, MD

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Dr Stearns on the Role of Carboplatin in Early-Stage TNBC

Dr Stearns on the Efficacy of Avelumab in TNBC