Adjuvant avelumab significantly improves survival in early TNBC

Results of the A-BRAVE trial showed that 1 year of treatment with avelumab improved distant disease-free survival (DDFS) and overall survival (OS) in patients with early triple-negative breast cancer (TNBC) who are at high risk of recurrence after adjuvant or neoadjuvant chemotherapy.

The prognosis of patients with early TNBC remains poor, and new effective treatments are needed. TNBC is the most immunogenic breast cancer subtype, which may account for sensitivity to immune checkpoint inhibitors. The randomised, 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 who completed locoregional and systemic treatment with curative intent and were at high risk of recurrence. Of note: A-BRAVE was designed in 2015; until 2022, immune therapy was not approved for first-line (neo)adjuvant treatment of patients with (high-risk) early TNBC.

High risk of recurrence was defined as follows:

• pN2–3/any pT, pN1/pT2, or pN0/pT3–4 after primary surgery and adjuvant chemotherapy (Stratum A).
• Invasive residual disease (breast and/or nodes) after neoadjuvant chemotherapy (Stratum B).

The study randomised 477 participants 1:1 to adjuvant avelumab (10 mg/kg every 2 weeks, for 52 weeks) or observation, balanced for both strata. Prof. Pierfranco Conte (University of Padova, Italy) presented the results [1].

Adjuvant treatment with avelumab induced a numerical but not statistically significant improvement in 3-year disease-free survival rate in the intention-to-treat (ITT) population: 68.3% versus 63.2 % (HR 0.81; 95% CI 0.61–1.09; P=0.172). The 3-year disease-free survival rate in stratum B participants was comparable with that in the ITT population: 66.9% versus 60.7% (HR 0.80; 95% CI 0.58–1.10; P=0.170).

The 3-year overall survival rate in the ITT population was statistically significantly improved by adjuvant avelumab therapy: 84.8% versus 76.3% (HR 0.66; 95% CI 0.45–0.97); P=0.035). In addition, the 3-year distant disease-free survival rate was improved by avelumab therapy: 75.4% versus 67.9% (HR 0.70; 95% CI 0.50–0.96; P=0.0277).

Avelumab was well tolerated and most of the participants were able to complete the treatment.

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

1. Conte PF, et al. A-BRAVE trial: A phase III randomized trial with avelumab in early triple-negative breast cancer with residual disease after neoadjuvant chemotherapy or at high risk after primary surgery and adjuvant chemotherapy. Abstract LBA500, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202418 July 2024