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Cited by 4,350Breast Cancer Treatment StudiesCancer Immunotherapy and BiomarkersCancer Treatment and Pharmacology

Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer

Open access
Schmid, Peter, Adams, Sylvia, Rugo, Hope S., Schneeweiss, Andreas, Barrios, Carlos H., Iwata, Hiroji, Diéras, Véronique, Hegg, Roberto +10 more·2018·New England Journal of Medicine
DOI 10.1056/nejmoa1809615
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Abstract

BACKGROUND: Unresectable locally advanced or metastatic triple-negative (hormone-receptor-negative and human epidermal growth factor receptor 2 [HER2]-negative) breast cancer is an aggressive disease with poor outcomes. Nanoparticle albumin-bound (nab)-paclitaxel may enhance the anticancer activity of atezolizumab. METHODS: In this phase 3 trial, we randomly assigned (in a 1:1 ratio) patients with untreated metastatic triple-negative breast cancer to receive atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel; patients continued the intervention until disease progression or an unacceptable level of toxic effects occurred. Stratification factors were the receipt or nonreceipt of neoadjuvant or adjuvant taxane therapy, the presence or absence of liver metastases at baseline, and programmed death ligand 1 (PD-L1) expression at baseline (positive vs. negative). The two primary end points were progression-free survival (in the intention-to-treat population and PD-L1-positive subgroup) and overall survival (tested in the intention-to-treat population; if the finding was significant, then it would be tested in the PD-L1-positive subgroup). RESULTS: Each group included 451 patients (median follow-up, 12.9 months). In the intention-to-treat analysis, the median progression-free survival was 7.2 months with atezolizumab plus nab-paclitaxel, as compared with 5.5 months with placebo plus nab-paclitaxel (hazard ratio for progression or death, 0.80; 95% confidence interval [CI], 0.69 to 0.92; P=0.002); among patients with PD-L1-positive tumors, the median progression-free survival was 7.5 months and 5.0 months, respectively (hazard ratio, 0.62; 95% CI, 0.49 to 0.78; P<0.001). In the intention-to-treat analysis, the median overall survival was 21.3 months with atezolizumab plus nab-paclitaxel and 17.6 months with placebo plus nab-paclitaxel (hazard ratio for death, 0.84; 95% CI, 0.69 to 1.02; P=0.08); among patients with PD-L1-positive tumors, the median overall survival was 25.0 months and 15.5 months, respectively (hazard ratio, 0.62; 95% CI, 0.45 to 0.86). No new adverse effects were identified. Adverse events that led to the discontinuation of any agent occurred in 15.9% of the patients who received atezolizumab plus nab-paclitaxel and in 8.2% of those who received placebo plus nab-paclitaxel. CONCLUSIONS: Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patients with metastatic triple-negative breast cancer in both the intention-to-treat population and the PD-L1-positive subgroup. Adverse events were consistent with the known safety profiles of each agent. (Funded by F. Hoffmann-La Roche/Genentech; IMpassion130 ClinicalTrials.gov number, NCT02425891 .).

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Crossref · 10.1056/nejmoa1809615

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  • PD-L1 status by SP142 is the companion test for atezolizumab plus a taxane in first-line triple-negative advanced breast cancer, with a cut-off of 1% positive staining on immune cells.

    “Thus, PD-L1 status by SP142 is the companion test for the use of atezolizumab in combination with a taxane for first-line therapy in triple-negative ABC, with a cut-off of 1% positive staining on immune cells.”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]

    Trial Design and Procedures (page not provided) defines PD-L1 positivity as expression on tumor-infiltrating immune cells covering at least 1% of tumor area, and the Discussion reports first-line benefit with atezolizumab plus nab-paclitaxel. The paper does not establish SP142 as a companion test in its trial description; SP142 appears in a reference to a *complementary* diagnostic assay. The claim also broadens nab-paclitaxel to taxanes generally and describes the cutoff as 1% of immune cells staining positive rather than 1% of tumor area. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In the PD-L1-positive population of IMpassion-130, an overall survival analysis showed 25 vs 15.1 months favouring atezolizumab.

    “an analysis was conducted and presented, and showed an OS of 25 months versus 15.1 months favouring the atezolizumab arm.”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]

    The Interim Overall Survival Analysis reports median overall survival of 25.0 months with atezolizumab plus nab-paclitaxel versus 15.5 months with placebo plus nab-paclitaxel in the PD-L1-positive subgroup—not 15.1 months. It also says formal testing of overall survival in that subgroup was not conducted at this interim analysis. (LLM, conf=0.91)

    Experimental — accuracy not yet measured

  • In PD-L1-positive patients in IMpassion-130, atezolizumab plus nab-paclitaxel improved progression-free survival (7.5 vs 5 months; HR 0.62, 95% CI 0.49-0.78, P<0.001).

    “In the PD-L1 positive group, atezolizumab provided a PFS benefit of 7.5 versus 5 months with a HR of 0.62 (95% CI 0.49-0.78, P < 0.001).”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]

  • In the intention-to-treat population of IMpassion-130, adding atezolizumab to nab-paclitaxel improved progression-free survival compared with nab-paclitaxel alone (7.2 vs 5.5 months; HR 0.8, 95% CI 0.69-0.92, P=0.002).

    “In the ITT population, atezolizumab provided a benefit in PFS of 7.2 versus 5.5 months with a HR of 0.8 (95% CI 0.69-0.92, P = 0.002).”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]

  • In the intention-to-treat population of IMpassion-130, there was no significant overall survival benefit with atezolizumab; median overall survival was 21.3 vs 17.6 months (HR 0.84; 95% CI 0.69-1.02, P=0.08).

    “In the ITT population, there was no significant benefit in OS with the addition of atezolizumab; median OS was 21.3 months versus 17.6 months (HR 0.84; 95% CI 0.69-1.02, P = 0.08).”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]

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Cites

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Research works printed but not linked: 2

  1. [16]16. Emens LA, Middleton G. The inter- play of immunotherapy and chemother- apy: harnessing potential synergies. Can- cer Immunol Res 2015; 3: 436-43.
  2. [20]20. Adams S, Diamond JR, Hamilton E, et al. Atezolizumab plus nab-paclitaxel in the treatment of metastatic triple-negative breast cancer with 2-year survival follow- up: a phase 1b clinical trial. JAMA Oncol (in press).

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Authors
Schmid, P., Adams, S., Rugo, H. S., Schneeweiss, A., Barrios, C. H., Iwata, H., Diéras, V., Hegg, R., Im, S.-A., Shaw Wright, G., Henschel, V., Molinero, L., Chui, S. Y., Funke, R., Husain, A., Winer, E. P., Loi, S., & Emens, L. A.
Affiliations
  • Queen Mary University of London (GB)
  • From the Barts Cancer Institute, Queen Mary University of London, London (P.S.); Perlmutter Cancer Center, New York University School of Medicine, New York (S.A.); the Department of Medicine, University of California, San Francisco, San Francisco (H.S.R.), and Genentech, South San Francisco (L.M., S.Y.C., R.F.) — both in California; University Hospital Heidelberg, Heidelberg, Germany (A.S.); Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul,...
  • Seoul National University (KR)
  • F. Hoffmann-La Roche AG (CH)
  • The University of Melbourne (AU)
  • Johns Hopkins University (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2018-11-29
Volume
379
Issue
22
Pages
2108-2121
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1809615
OpenAlex
W2897422388
Cited by
4,350
References
32
Citations by year
2026: 310 · 2025: 409 · 2024: 453 · 2023: 562 · 2022: 648 · 2021: 825 · 2020: 723 · 2019: 397 · 2018: 17 · 2017: 1 · 2016: 1 · 2013: 1
FWCI
148.10
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Seoul National University Open Repository (Seoul National University) (submittedVersion)
Funders
F. Hoffmann-La Roche/Genentech
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Keywords
atezolizumab, nab-paclitaxel, triple-negative breast cancer, metastatic breast cancer, PD-L1 expression, immune checkpoint inhibitors, combination chemotherapy, progression-free survival, overall survival, liver metastasis, immune-related adverse events, PD-1/PD-L1 inhibitors
MeSH terms
Progression-Free Survival, Adult, Aged, Albumins, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Middle Aged, Survival Analysis, Paclitaxel, Intention to Treat Analysis, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms

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