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In patients with early triple-negative breast cancer (TBC) who are at high risk after adjuvant or neoadjuvant chemotherapy, 1 year of treatment with avelumab improves distant disease-free survival (DDFS) and overall survival (OS), results from the A-BRAVE trial showed.

The prognosis of patients with early TNBC is still poor and new effective treatments are needed. TNBC is the most immunogenic breast cancer subtype, and this may account for sensitivity to immune checkpoint inhibitors. The randomized, phase 3 A-BRAVE trial (NCT02926196) was designed to evaluate the efficacy of avelumab, an anti-PD-L1 antibody, as adjuvant or post-neoadjuvant treatment for patients with early TNBC at high risk who completed locoregional and systemic treatment with curative intent and are at high risk for recurrence.

High risk for recurrence was defined as: pN2/any pT, pN1/pT2, or pN0/pT3 after primary surgery and adjuvant chemotherapy (Stratum A) or invasive residual disease (breast and/or nodes) after neoadjuvant chemotherapy (Stratum B).

A total of 477 patients were enrolled and 1:1 randomly assigned to adjuvant avelumab (10 mg/kg Q2W for 52 weeks) for observation. Patients in stratum A (n=83) were equally distributed over both arms. Dr. Pier Franco Conte, PhD, from the Università di Padova, in Italy, presented the results¹.

Adjuvant treatment with avelumab induced a numerical, but not statistically significant improvement in 3 year DDFS rate in the intention to treat (ITT) population: 68.3% (95% CI 61.9-73.8) versus 63.2% (95% CI 56.5-69.2); HR 0.81 (95% CI 0.61-01.09; P=0.172). The efficacy of avelumab on 3 year DDFS rate in patients in stratum B was comparable to the efficacy in the ITT population: 66.9% versus 60.7% (HR 0.80; P=0.170).

3 year overall survival rate in the ITT population was statistically significantly improved by adjuvant avelumab: 84.8% (95% CI 79.5-88.8) versus 76.3% (95% CI 70.1-81.3; HR 0.66 95% CI 0.45-0.97; P=0.035). in addition, 3 year DDFS survival rate was improved by avelumab: 75.4% (95% CI 69.3-80.4) versus 67.9% (95% CI 61.4-73.5; HR 0.70 95% CI 0.50-0.96; P=0.0277). Avelumab was well tolerated and most of the patients were able to complete the treatment.

Dr. Conte concluded that “the 30% reduction of the risk for distant metastases and 34% reduction of the risk for death suggests that avelumab may have a role in patients with early TBC at high risk after primary surgery or with invasive residual disease after neoadjuvant chemotherapy.”

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