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Breast Cancer · Medical · Advanced / Metastatic

IMpassion130

In first-line advanced TNBC, does atezolizumab plus nab-paclitaxel improve outcomes versus nab-paclitaxel alone?

Trial design and population

Population / eligibility
902 patients with previously untreated unresectable locally advanced or metastatic TNBC; PD-L1-positive subgroup defined as immune-cell expression ≥1% by SP142.
Intervention vs comparator
Atezolizumab 840 mg IV days 1 and 15 plus nab-paclitaxel 100 mg/m² days 1, 8 and 15 every 28 days vs placebo plus nab-paclitaxel.
Sample size
902
Primary endpoint
PFS and OS in ITT and PD-L1-positive populations

Key results

Median PFS in ITT was 7.2 vs 5.5 months (HR 0.80); in PD-L1-positive disease it was 7.5 vs 5.0 months (HR 0.62). Updated median OS was 21.0 vs 18.7 months in ITT (HR 0.86, 95% CI 0.72–1.02; P=.078); in PD-L1-positive disease, 25.0 vs 18.0 months (HR 0.71), but formal OS testing was precluded by the statistical hierarchy.

Source-reported outcome visualization

Median PFS (PD-L1-positive) · Median

Atezolizumab + nab-paclitaxel
7.5 months
Placebo + nab-paclitaxel
5 months

Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.

Absolute Effect

Median PFS difference in PD-L1-positive subgroup was 2.5 months; not an NNT. PD-L1-positive OS signal was not formally confirmatory under the prespecified testing hierarchy.

NNT: Not calculated; median endpoints and hierarchical OS limitation. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.

NNH: Not quantifiable. Grade 3–4 neutropenia about 8%, peripheral neuropathy about 6% vs 3%; rare treatment-related deaths occurred in both groups. Nab-paclitaxel toxicity and immune-mediated events require monitoring.

Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.

Safety and treatment burden

Grade 3–4 neutropenia about 8%, peripheral neuropathy about 6% vs 3%; rare treatment-related deaths occurred in both groups. Nab-paclitaxel toxicity and immune-mediated events require monitoring.

Follow-up, maturity and limitations

Follow-up: Updated OS analysis median follow-up approximately 18 months.

ITT OS did not cross the prespecified significance boundary, so the PD-L1-positive OS finding was not formally tested. Regulatory status varies by jurisdiction.

Clinical interpretation

IMpassion130 improved PFS, with a strong PD-L1-positive subgroup signal, but overall OS was not statistically significant and must not be conflated with IMpassion131.

Current-practice context · reviewed 20 October 2026

This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.

Primary and authoritative sources

Schmid P, et al. Updated efficacy results from IMpassion130. Lancet Oncol. 2020. Source ↗
ClinicalTrials.gov NCT02425891 Source ↗