Breast (Edinburgh, Scotland) · 2026
Primary results from EL1SSAR, a prospective phase IIIb study of first-line atezolizumab plus nab-paclitaxel therapy for patients with PD-L1-positive advanced triple-negative breast cancer.
СтатьяКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Gianni L, Delaloge S, Ciruelos E, Trédan O, Castañeda C, Abreu M H, Paris I, Colleoni M, Scandurra G, Kwiatkowski M, Antone N, Gregorc V, Tagliaferri P, Borštnar S, Blancas I, Raimondo M, Alfie M, Arce-Salinas C, Madeira P S, Lin Y G, Ye C, Koli K, Mouta J, Martin M
Аннотация
BACKGROUND: IMpassion130 trial results led to approval of first-line atezolizumab plus nab-paclitaxel for PD-L1-positive advanced triple-negative breast cancer (aTNBC). The global single-arm EL1SSAR study (NCT04148911) enrolled a broader patient population to elucidate outcomes in routine practice.
METHODS: Patients with measurable PD-L1-positive aTNBC and no prior systemic therapy for advanced disease received atezolizumab (840 mg, days 1&15) plus nab-paclitaxel (100 mg/m2, days 1,8,15) every 28 days until disease progression or unacceptable toxicity. PD-L1 status was assessed locally (mandatory) and centrally (optional) using the VENTANA PD-L1 (SP142) Assay. Patients with stable asymptomatic CNS metastases, ECOG PS 2 or selected autoimmune diseases were allowed. Primary endpoints were the incidence of grade ≥2 immune-mediated and grade ≥3 adverse events (AEs). Secondary endpoints included overall survival and investigator-assessed progression-free survival (PFS). PD-L1 testing concordance was an exploratory endpoint.
RESULTS: Among 182 treated patients, five had CNS metastases and three had ECOG PS ≥ 2. Patients received a median of six treatment cycles (range 1-63); 7% were treated for >3 years. Grade ≥2 immune-mediated AEs occurred in 12% of patients (95% CI 8%-18%) and grade ≥3 AEs in 47% (95% CI 39%-54%). There were no treatment-related deaths. Median PFS was 7.4 (95% CI 5.6-10.6) months (>2 years in 27 patients [15%]) and median overall survival was 27.0 (95% CI 22.0-33.8) months. Concordance between local and central PD-L1 testing was 67% (65/97). Median PFS was >11 months in patients with centrally confirmed PD-L1-positive status.
CONCLUSIONS: Safety and efficacy were consistent with results from IMpassion130, which enrolled a more selected population.
METHODS: Patients with measurable PD-L1-positive aTNBC and no prior systemic therapy for advanced disease received atezolizumab (840 mg, days 1&15) plus nab-paclitaxel (100 mg/m2, days 1,8,15) every 28 days until disease progression or unacceptable toxicity. PD-L1 status was assessed locally (mandatory) and centrally (optional) using the VENTANA PD-L1 (SP142) Assay. Patients with stable asymptomatic CNS metastases, ECOG PS 2 or selected autoimmune diseases were allowed. Primary endpoints were the incidence of grade ≥2 immune-mediated and grade ≥3 adverse events (AEs). Secondary endpoints included overall survival and investigator-assessed progression-free survival (PFS). PD-L1 testing concordance was an exploratory endpoint.
RESULTS: Among 182 treated patients, five had CNS metastases and three had ECOG PS ≥ 2. Patients received a median of six treatment cycles (range 1-63); 7% were treated for >3 years. Grade ≥2 immune-mediated AEs occurred in 12% of patients (95% CI 8%-18%) and grade ≥3 AEs in 47% (95% CI 39%-54%). There were no treatment-related deaths. Median PFS was 7.4 (95% CI 5.6-10.6) months (>2 years in 27 patients [15%]) and median overall survival was 27.0 (95% CI 22.0-33.8) months. Concordance between local and central PD-L1 testing was 67% (65/97). Median PFS was >11 months in patients with centrally confirmed PD-L1-positive status.
CONCLUSIONS: Safety and efficacy were consistent with results from IMpassion130, which enrolled a more selected population.