Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

MONARCH 2: Abemaciclib Plus Fulvestrant Improves Overall Survival

Key clinical point: Adding the CDK4/6 inhibitor abemaciclib to fulvestrant significantly improves overall survival in HR+, HER2– advanced breast cancer patients who progressed on prior endocrine therapy.

Major finding: Overall survival at 47.7 months was 46.7 vs. 37.3 months in the treatment group vs. placebo group respectively (hazard ratio, 0.757).

Study details: The phase 3 MONARCH 2 trial of 669 patients.

Disclosures: Dr. Sledge has received trial support, research grants, and travel accommodations from Eli Lilly and Company; is a board member for Tessa Therapeutics; and is a consultant for Syndax, Symphogen, and Verseau Therapeutics. Dr. Harbeck disclosed financial relationships with Agendia, Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Genomic Health, Lilly, MSD, NanoString, Novartis, Odonate, Pfizer, Roche, Sandoz/Hexal, and Seattle Genetics. She is also director of the West German Study Group and a member of the German AGO Breast Committee.


Sledge G et al. ESMO 2019, Abstract LBA6-PR.