In IMpassion050 (NCT03726879), adding atezolizumab (A) to neoadjuvant chemotherapy (CT) and pertuzumab–trastuzumab (PH) did not increase pathological complete response (pCR) vs placebo (Pl), CT and PH in patients (pts) with high-risk, HER2-positive (+) early breast cancer (EBC) in either the intention-to-treat or PD-L1+ populations. Additional BM data are warranted to better inform future immunotherapeutic strategies in HER2+ BC. We report exploratory analyses of the relationship between BMs with pCR, and their dynamics.
Overall, 454 pts with centrally confirmed HER2+, node+ EBC were randomly assigned to 8 cycles of A and CT with 4 cycles of PH, followed by A plus PH until completion of 1 year of treatment after surgery, or Pl, CT and PH followed by Pl plus PH. Pre-specified HER2, hormone receptor (HR), PD-L1 and
BM characteristics were well balanced between arms: 89% of tumours were HER2 immunohistochemistry (IHC) 3+; 51%, HR+ (capping at 50%); 48%, PD-L1+; 28%,
OR 95% CI p-value N=411 Treatment effect (reference: Pl arm) A arm 1.00 0.65, 1.54 0.9972 HER2 IHC 2+/3+ staining pattern (reference: focal/heterogeneous) Homogeneous (≥80% staining) 2.51 1.46, 4.31 0.0009 ≥4 1.94 1.18, 3.20 0.0091 HR status (reference: oestrogen and/or progesterone receptor+) Oestrogen and progesterone receptor-negative 2.41 1.55, 3.76 0.0001 PD-L1 status (reference: tumour-infiltrating immune cells [IC] 0) IC 1/2/3 1.61 1.04, 2.49 0.0321 No mutation detected 1.72 1.07, 2.77 0.0264
There was no differential treatment effect detected with the addition of A to CT and PH according to BMs analysed. HER2 IHC staining pattern, gene ratio, and HR, PD-L1 and
NCT03726879.
Support for third-party editing assistance for this abstract, furnished by Daniel Clyde, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd., Basel, Switzerland.
F. Hoffmann-La Roche Ltd.
F. Hoffmann-La Roche Ltd.
H.A. Zhang: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Advisory Role: Roche/Genentech; Financial Interests, Personal, Funding, Research funding: Roche. C. Lambertini: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd.; Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd. D. Eiger: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd.; Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd. C.H. Barrios: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Stocks/Shares: MedSIR, Tummi; Financial Interests, Personal, Other, Honoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Eisai, MSD, Lilly, Bayer, AstraZeneca, Zodiac Pharma; Financial Interests, Personal, Other, Travel, accommodations, expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, Lilly; Financial Interests, Institutional, Funding, Research funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Clinica Atlantis, INC Research, Halozyme, Covance, Celgene, inVentiv Health, Shanghai Henlius Biotech, Polyphor, PharmaMar; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United Medical, Lilly. 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Hoffmann-La Roche Ltd.; Financial Interests, Personal, Other, Honoraria: Roche, Novartis, Pfizer; Financial Interests, Personal, Advisory Role: Pfizer, Novartis, Lilly, Roche; Financial Interests, Personal, Speaker’s Bureau: Exact Sciences, Roche, Novartis, Pfizer; Financial Interests, Personal, Funding, Research funding: Roche; Financial Interests, Personal, Other, Travel, accommodations, expenses: Pfizer, Lilly, Roche, Novartis. Y. Chang: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Funding, Research funding: Roche. S.L. Huggins-Puhalla: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Advisory Role: AbbVie, Roche/Genentech; Financial Interests, Institutional, Funding, Research funding: AbbVie, Pfizer, AstraZeneca. M. 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Huober: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.; Financial Interests, Institutional, Research Grant: Novartis, Lilly; Financial Interests, Personal, Other, Consulting fees: Lilly, Novartis, Roche, Pfizer, Hexal, AstraZeneca, MSD, Celgene, AbbVie, Daiichi, Gilead; Financial Interests, Personal, Other, Honoraria: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene; Eisai, AbbVie, Seagen, Gilead, Daiichi; Financial Interests, Personal, Other, Travel: Roche, Pfizer, Novartis, Celgene, Daiichi, Gilead.