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Randomized Controlled Trial
. 2021 Aug;32(8):983-993.
doi: 10.1016/j.annonc.2021.05.355. Epub 2021 Jul 1.

First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis

L A Emens  1 , S Adams  2 , C H Barrios  3 , V Diéras  4 , H Iwata  5 , S Loi  6 , H S Rugo  7 , A Schneeweiss  8 , E P Winer  9 , S Patel  10 , V Henschel  11 , A Swat  12 , M Kaul  13 , L Molinero  14 , S Patel  15 , S Y Chui  10 , P Schmid  16
Affiliations
Free article
Randomized Controlled Trial

First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis

L A Emens et al. Ann Oncol. 2021 Aug.
Free article

Erratum in

Abstract

Background: Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report the final overall survival (OS) and safety of that study as per the prespecified analysis plan.

Patients and methods: Patients were randomized to nP 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) with atezolizumab 840 mg (A + nP) or placebo (P + nP; days 1 and 15), until progression or unacceptable toxicity. Coprimary endpoints were progression-free survival [intention-to-treat (ITT) and PD-L1 IC-positive populations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-positive population).

Results: Each arm comprised 451 patients; 666 (73.8%) had died by the final OS analysis cut-off (median follow-up, 18.8 months; interquartile range, 8.9-34.7 months). Median OS in the ITT population was 21.0 months [95% confidence interval (CI), 19.0-23.4 months] with A + nP, and 18.7 months (95% CI, 16.9-20.8 months) with P + nP [stratified hazard ratio (HR), 0.87; 95% CI, 0.75-1.02; P = 0.077]. Exploratory analysis in the PD-L1 IC-positive population showed a median OS of 25.4 months (95% CI, 19.6-30.7 months) with A + nP (n = 185) and 17.9 months (95% CI, 13.6-20.3 months) with P + nP (n = 184; stratified HR, 0.67; 95% CI, 0.53-0.86). Safety outcomes were consistent with previous analyses and the known toxicity profiles of each agent. Immune-mediated adverse events of special interest were reported in 58.7% and 41.6% of patients treated with A + nP and P + nP, respectively.

Conclusion: Although the OS benefit in the ITT population was not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained safe and tolerable with longer follow-up.

Keywords: atezolizumab; first-line treatment; immune checkpoint inhibitor; metastatic; nab-paclitaxel; triple-negative breast cancer.

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Conflict of interest statement

Disclosure F. Hoffmann-La Roche, Ltd. provided financial support and non-financial support to all authors during the conduct of the study and also funded editorial support provided by independent medical writers under the guidance of the authors. LAE is co-chair of the steering committee for the IMpassion130 study and the KATE3 study, and was chair of the KATE2 study steering committee; reports honoraria from AbbVie, Amgen, Celgene, Chugai, GCPR, Gilead, Gritstone, MedImmune, Peregrine, Shionogi, and Syndax; honoraria and travel support from AstraZeneca, Bayer, MacroGenics, Replimune, and Vaccinex; travel support from Bristol Myers Squibb, Genentech/Roche, and Novartis; potential future stock from Molecuvax; institutional support from AbbVie, Aduro Biotech, AstraZeneca, the Breast Cancer Research Foundation, Bristol Myers Squibb, Bolt Therapeutics, Compugen, Corvus, CyTomX, the US Department of Defense, EMD Serono, Genentech, Maxcyte, Merck, the National Cancer Institute, the NSABP Foundation, SU2C, Silverback, Roche, the Translational Breast Cancer Research Consortium, Takeda, Tempest, and HeritX; and royalties from Aduro Biotech. SA reports uncompensated consulting or advisory roles with Bristol Meyers Squibb, Genentech, and Merck and reports research funding to her institution from Amgen, Bristol Meyers Squibb, Celgene, Genentech, Merck, and Novartis. CHB reports research grants from Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Eli Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas, BioMarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana BioSciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, and Millennium and consulting fees from Roche/Genentech, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Pfizer, Eisai, Bayer, Merck Sharp and Dohme, and AstraZeneca. VD reports honoraria from AbbVie, AstraZeneca, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, Roche/Genentech, and Seattle Genetics; a consulting or advisory role with AbbVie, AstraZeneca, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, Roche/Genentech, and Seattle Genetics; payment for participation in a speakers' bureau or symposium from AstraZeneca, Daiichi Sankyo, Lilly, Novartis, Pfizer, and Roche; and travel fees from AstraZeneca, Daiichi Sankyo, Lilly, Novartis, Pfizer, and Roche. HI serves as an uncompensated member of the steering committee for the IMpassion130 trial; and reports honoraria from AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Kyowa Hakko Kirin, Lilly, Pfizer, and Taiho; consulting fees from AstraZeneca, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, and Pfizer; and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, MSD, Nihon kayaku, Novartis, Pfizer, and Sanofi. SL reports research funding to her institution from Novartis, Bristol Myers Squibb, Merck, Roche, Genentech, Puma, Pfizer, and Eli Lilly; has acted as an unpaid consultant to Seattle Genetics, Pfizer, Novartis, Bristol Myers Squibb, Merck, AstraZeneca, and Roche/Genentech; and acted as a consultant to Aduro Biotech (fees paid to her institution). HSR reports research support for clinical trials through the University of California from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Genentech, Immunomedics, Lilly, Macrogenics, Merck, Novartis, Odonate, Pfizer, Polyphor, Seattle Genetics, and Sermonix; travel support from AstraZeneca, Daiichi Sankyo, Merck, Mylan, Novartis, Pfizer, and Puma; and honoraria from Mylan, Puma, and Samsung. AS reports research grants from Celgene, F. Hoffmann-La Roche, AbbVie and Molecular Partners; consulting fees and travel expenses from F. Hoffmann-La Roche and AstraZeneca; honoraria from F. Hoffmann-La Roche, Celgene, AstraZeneca, Novartis, Merck Sharp and Dohme, Tesaro, and Eli Lilly; and honoraria and travel expenses from Pfizer. EPW reports honoraria from Eli Lilly, Leap, Genentech, Infinite MD, Carrick Therapeutics, GlaxoSmithKline, Jounce, Genomic Health, Merck, and Seattle Genetics and is a scientific advisory board member for Leap. SP, MK, and SP report employment at and stock from Genentech/Roche during the conduct of the study. VH and AS report employment at and stock from Roche during the conduct of the study. LM and SYC report employment at and stock from Genentech/Roche during the conduct of the study and have a use patent to disclose with Roche/Genentech. PS reports research support (grants) to his institution from Genentech, F. Hoffmann-La Roche, OncoGenex, and Novartis; reports honoraria from AstraZeneca, F. Hoffmann-La Roche, Medscape, and G1 Therapeutics; reports a consulting or advisory role with AstraZeneca, Novartis, F. Hoffmann-La Roche, Merck, Boehringer Ingelheim, Bayer, Eisai, Celgene, Pfizer, and Puma; is an uncompensated steering committee member for the IMpassion130 trial; and reports that his spouse has a consulting role for Genentech and F. Hoffmann-La Roche. Data sharing Qualified researchers may request access to individual patient-level data through the clinical study data request platform (https://vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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