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Importance: Triple-negative breast cancer is an aggressive subtype with a high incidence in young patients, a high incidence in non-Hispanic Black women, and a high risk of progression to metastatic cancer, a devastating sequela with a 12- to 18-month life expectancy. Until recently, one strategy for treating early-stage triple-negative breast cancer was chemotherapy after surgery. However, it was not known whether the addition of immune therapy to postsurgery chemotherapy would be beneficial., Objective: To evaluate the addition of immune therapy in the form of atezolizumab to postoperative chemotherapy in patients with the high-risk triple-negative breast cancer subtype., Design, Setting, and Participants: In this open-label international randomized phase 3 trial conducted in more than 330 centers in 31 countries, patients undergoing surgery as initial treatment for stage II or III triple-negative breast cancer were enrolled between August 2, 2018, and November 11, 2022. The last patient follow-up was on August 18, 2023., Interventions: Patients were randomized (1:1) to receive standard chemotherapy for 20 weeks with (n = 1101) or without (n = 1098) the immune therapy drug atezolizumab for up to 1 year., Main Outcomes and Measures: The primary end point was invasive disease-free survival (time between randomization and invasive breast cancer in the same or opposite breast, recurrence elsewhere in the body, or death from any cause)., Results: The median age of enrolled patients was 53 years and most self-reported as being of Asian or White race and neither Latino nor Hispanic ethnicity. The study independent data monitoring committee halted enrollment at 2199 of 2300 planned patients. All patients stopped atezolizumab following a planned early interim and futility analysis. The trial continued to a premature final analysis. With invasive disease-free survival events in 141 patients (12.8%) treated with atezolizumab-chemotherapy and 125 (11.4%) with chemotherapy alone (median follow-up, 32 months), the final stratified invasive disease-free survival hazard ratio was 1.11 (95% CI, 0.87-1.42; P = .38). Compared with chemotherapy alone, the regimen of atezolizumab plus chemotherapy was associated with more treatment-related grade 3 or 4 adverse events (54% vs 44%) but similar incidences of fatal adverse events (0.8% vs 0.6%) and adverse events leading to chemotherapy discontinuation. Chemotherapy exposure was similar in the 2 treatment groups., Conclusions and Relevance: The addition of the immune therapy drug atezolizumab to chemotherapy after surgery did not provide benefit among patients with triple-negative breast cancer who are at high risk of recurrent disease., Trial Registration: ClinicalTrials.gov Identifier: NCT03498716.

Introduction: Subcutaneous atezolizumab is approved for the treatment of various solid tumors. Previous results from the IMscin001 study (NCT03735121) revealed that the pharmacokinetics, efficacy, immunogenicity, and safety of subcutaneous and intravenous atezolizumab were consistent (data cutoff: April 26, 2022). We present updated data from this trial (data cutoff: January 16, 2023)., Methods: Eligible patients aged above or equal to 18 years with locally advanced or metastatic NSCLC were randomized (2:1) to receive atezolizumab subcutaneously (1875 mg, n = 247) or intravenously (1200 mg, n = 124) every 3 weeks. Here, we present updated efficacy (overall survival [OS]; progression-free survival; objective response rate; duration of response), safety, and immunogenicity end points, alongside patient-reported outcomes and health care practitioner (HCP) perspectives., Results: In this updated analysis, the median survival follow-up was 9.5 months. Median subcutaneous injection time was 7.1 minutes, with an average subcutaneous injection time of 4 to 8 minutes in most patients (75.7%). OS data were mature: median OS was similar between treatment arms, at 10.7 and 10.1 months in the subcutaneous and intravenous arms, respectively (hazard ratio: 0.88; 95% confidence interval: 0.67-1.16). Other efficacy end points, as well as immunogenicity, patient-reported outcomes, and safety, were similar between arms. Most HCPs found subcutaneous administration convenient (79.5%), easy to administer (89.7%), and were satisfied with the treatment (84.6%); 75.0% of HCPs agreed that administering atezolizumab subcutaneously compared with intravenously could save time., Conclusions: In this analysis, mature OS data were similar between treatments. The updated efficacy and safety profile of subcutaneous atezolizumab is consistent with previous findings and equivalent to intravenous atezolizumab., Competing Interests: Disclosure Dr. Burotto received honoraria or consulting fees from and has served on advisory boards for AstraZeneca, Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd., and Merck Sharp & Dohme. Dr. Zvirbule received honoraria from AstraZeneca and travel support for attending meetings from F. Hoffmann-La Roche Ltd., Merck Sharp & Dohme, and AstraZeneca. Dr. Chewaskulyong received honoraria or consulting fees from F. Hoffmann-La Roche Ltd. and has had a leadership or fiduciary role in other board, society, committee, or advocacy group for F. Hoffmann-La Roche Ltd. Dr. Herraez-Baranda is employed full time at F. Hoffmann-La Roche Ltd. and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Shearer-Kang is employed full time at Genentech and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Liu is employed full time at Genentech and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Tosti is employed full time at F. Hoffmann-La Roche Ltd. and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Williams is employed full time at Genentech and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Castro Sanchez is employed full time at F. Hoffmann-La Roche Ltd. and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Zanghi is employed full time at Genentech and has stocks or shares in F. Hoffmann-La Roche Ltd. Dr. Felip received honoraria or consulting fees from and has served on advisory boards for AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche Ltd., GlaxoSmithKline, Ipsen, Janssen, Medical Trends, Medscape, Merck KGaA, Merck Sharp & Dohme, Novartis, PeerVoice, Peptomyc, Pfizer, Sanofi, Takeda, Touch Oncology, and Turning Point; received travel support for attending meetings from AstraZeneca, Janssen, and F. Hoffmann-La Roche Ltd.; and is an independent member of the board for Grifols. Dr. Alvarez declares no conflict of interest., (Copyright © 2024 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)