TY - JOUR
T1 - Abemaciclib as initial therapy for advanced breast cancer
T2 - MONARCH 3 updated results in prognostic subgroups
AU - Johnston, Stephen
AU - O’Shaughnessy, Joyce
AU - Martin, Miguel
AU - Huober, Jens
AU - Toi, Masakazu
AU - Sohn, Joohyuk
AU - André, Valérie A.M.
AU - Martin, Holly R.
AU - Hardebeck, Molly C.
AU - Goetz, Matthew P.
N1 - Funding Information:
S.J. reports consulting/advisory fees and research funding from AstraZeneca, Eli Lilly and Company, Novartis, Pfizer, and Puma Biotechnology; research funding from Roche/Genentech; and is on the Speaker’s bureau of AstraZeneca, Novartis, Pfizer, Eisai, and Roche/Genentech. J.O.’S. reports consulting fees and is on the advisory boards of AbbVie Inc., Agendia, Amgen Biotechnology, AstraZeneca, Bristol-Myers Squibb, Celgene, Eisai, Genentech, Genomic Health, GRAIL, Immunomedics, Heron Therapeutics, Ipsen Biopharmaceuticals, Jounce Therapeutics, Eli Lilly and Company, Merck, Myriad, Novartis, Ondonate Therapeutics, Pfizer, Puma Biotechnology, prIME Oncology, Roche, Seattle Genetics, Syndax, Pharmaceuticals, and Takeda. M.M. reports grants and personal fees from Roche, Novartis, and, Puma Biotechnology; personal fees from Pierre Fabre, AstraZeneca, Taiho Oncology, Daiichi Sankyo, Pfizer, and Eli Lilly and Company. J.H. reports personal fees from Eli Lilly and Company, Novartis, Pfizer, AstraZeneca, Roche, MSD, Celgene, Eisai, AbbVie Inc., and Hexal; grants from Novartis, and Hexal; travel funding from Pfizer, Roche, Celgene, and Daiichi Sankyo. M.T. reports research grants from Chugai, Takeda, Pfizer, Kyowa-Hakko-Kirin, Taiho Oncology, JBCRG Association, Eisai, AstraZeneca, Daiichi Sankyo, Astellas, Shimadzu, AFI Technologies, and Nippon Kayaku; honoraria from Chugai, Takeda, Pfizer, Kyowa-Hakko-Kirin, Taiho Oncology, Eisai, Daiichi Sankyo, AstraZeneca, Eli Lilly and Company, MSD, Genomic Health, Novartis, Konica Minolta, BMS, Shimadzu, Yakult, and Nippon Kayaku; advisory role in Kyowa-Hakko-Kirin, Daiichi Sankyo, Athenex Oncology, and Bertis; and is on the board of directors of Japan Breast Cancer Research Group Association, Organization for Oncology and Translational Research, and Kyoto Breast Cancer Research Network. J.S. reports research grant and funding from MSD, Roche, Novartis, AstraZeneca, Eli Lilly and Company, Pfizer, Bayer, GSK, CONTESSA, and Daiichi Sankyo. V.A.M.A., H.R.M. and M.C. H. are employees of Eli Lilly and Company and hold company stocks. M.P.G. reports consulting fees to his organization from Eagle Pharmaceuticals, Eli Lilly and Company, Biovica, Novartis, Sermonix Pharmaceuticals, Context Therapeutics, Pfizer, and Biotheranostics; grants from Pfizer, Eli Lilly and Company, and Sermonix Pharmaceuticals.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - In MONARCH 3, continuous dosing of abemaciclib with an aromatase inhibitor (AI) conferred significant clinical benefit to postmenopausal women with HR+, HER2− advanced breast cancer. We report data for clinically prognostic subgroups: liver metastases, progesterone receptor status, tumor grade, bone-only disease, ECOG performance status, and treatment-free interval (TFI) from an additional 12-month follow-up (after final progression-free survival [PFS] readout). In the intent-to-treat population, after median follow-up of approximately 39 months, the updated PFS was 28.2 versus 14.8 months (hazard ratio [HR], 0.525; 95% confidence interval, 0.415–0.665) in abemaciclib versus placebo arms, respectively. Time to chemotherapy (HR, 0.513), time to second disease progression (HR, 0.637), and duration of response (HR, 0.466) were also statistically significantly prolonged with the addition of abemaciclib to AI. Treatment benefit was observed across all subgroups, as evidenced by objective response rate change from the addition of abemaciclib to AI, with the largest effects observed in patients with liver metastases, progesterone receptor-negative tumors, high-grade tumors, or TFI < 36 months. Extended follow-up in the MONARCH 3 trial further confirmed that the addition of abemaciclib to AI conferred significant treatment benefit to all subgroups, including those with poorer prognosis.
AB - In MONARCH 3, continuous dosing of abemaciclib with an aromatase inhibitor (AI) conferred significant clinical benefit to postmenopausal women with HR+, HER2− advanced breast cancer. We report data for clinically prognostic subgroups: liver metastases, progesterone receptor status, tumor grade, bone-only disease, ECOG performance status, and treatment-free interval (TFI) from an additional 12-month follow-up (after final progression-free survival [PFS] readout). In the intent-to-treat population, after median follow-up of approximately 39 months, the updated PFS was 28.2 versus 14.8 months (hazard ratio [HR], 0.525; 95% confidence interval, 0.415–0.665) in abemaciclib versus placebo arms, respectively. Time to chemotherapy (HR, 0.513), time to second disease progression (HR, 0.637), and duration of response (HR, 0.466) were also statistically significantly prolonged with the addition of abemaciclib to AI. Treatment benefit was observed across all subgroups, as evidenced by objective response rate change from the addition of abemaciclib to AI, with the largest effects observed in patients with liver metastases, progesterone receptor-negative tumors, high-grade tumors, or TFI < 36 months. Extended follow-up in the MONARCH 3 trial further confirmed that the addition of abemaciclib to AI conferred significant treatment benefit to all subgroups, including those with poorer prognosis.
UR - http://www.scopus.com/inward/record.url?scp=85108336793&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85108336793&partnerID=8YFLogxK
U2 - 10.1038/s41523-021-00289-7
DO - 10.1038/s41523-021-00289-7
M3 - Article
AN - SCOPUS:85108336793
SN - 2374-4677
VL - 7
JO - npj Breast Cancer
JF - npj Breast Cancer
IS - 1
M1 - 80
ER -