Results from a Phase IIIb clinical trial evaluating atezolizumab (Tecentriq Hybreza) in combination with nab-paclitaxel for unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) were posted on ClinicalTrials.gov on 2025-12-26. The study reported a median overall survival of 27.0 months in the safety-evaluable population.
Background
Triple-Negative Breast Cancer (TNBC) is a challenging form of breast cancer, particularly when it is unresectable locally advanced or metastatic. The study specifically focused on patients with PD-L1-positive disease who had not received prior chemotherapy for their advanced or metastatic condition.
Trial design
The completed Phase IIIb, open-label, single-arm study, identified as NCT04148911, investigated the combination of atezolizumab and nab-paclitaxel. The trial enrolled 184 participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer who had not previously received chemotherapy for their advanced disease.
Key results
The trial reported the following key measurements for the atezolizumab plus nab-paclitaxel treatment group:
- Median Overall Survival (OS) in the safety-evaluable population was 27.0 months.
- Median Progression Free Survival (PFS) in the safety-evaluable population was 7.4 months.
- Median PFS in the PD-L1-positive population was 11.1 months.
- The percentage of participants with all treatment-emergent adverse events (AEs) was 95.60%.
- The percentage of participants with treatment-emergent Grade ≥3 AEs was 46.70%.
- The percentage of participants with all treatment-emergent serious adverse events (SAEs) was 16.48%.
- The percentage of participants with treatment-emergent Grade ≥2 immune-mediated AEs (imAEs) was 12.09%.
What this means
The results from this Phase IIIb single-arm study provide data on the efficacy and safety profile of atezolizumab in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer. The reported median overall survival of 27.0 months and median progression-free survival of 11.1 months in the PD-L1-positive population indicate the activity of this regimen in this specific patient group. The safety data, including the percentage of participants experiencing various grades of adverse events, offers insights into the tolerability of the combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04148911, titled "A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer," were posted on 2025-12-26 on clinicaltrials.gov.