Abemaciclib, NSAI Extend Overall Survival for Patients With Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

Pharmacy Practice in Focus: OncologyJanuary 2024
Volume 6
Issue 1

The combination resulted in numerically longer OS compared with an NSAI alone.

Final overall survival (OS) data from the MONARCH 3 study (NCT02246621) showed that the combination of abemaciclib (Verzenio; Lilly) and a nonsteroidal aromatase inhibitor (NSAI) as first-line therapy for hormone receptor–positive, HER2-negative (HER2–) advanced breast cancer resulted in numerically longer OS compared with an NSAI alone, although the results did not meet statistical significance. The data were presented at the 2023 San Antonio Breast Cancer Symposium in Texas.

Health care professinal shows model of breast with tumor -- Image credit: Peakstock | stock.adobe.com

Image credit: Peakstock | stock.adobe.com

MONARCH 3 is a randomized, double-blind, phase 3 study of abemaciclib plus an NSAI (anastrozole or letrozole) vs placebo plus an NSAI in postmenopausal women with hormone receptor–positive, HER2– advanced breast cancer without prior systemic therapy in the advanced setting. OS was a gated secondary end point, and chemotherapy-free survival was an exploratory end point.

Presenter Matthew Goetz, MD, an oncologist at Mayo Clinic in Rochester, Minnesota, noted that there have been 2 previous interim analyses of OS and these are the final data. “The previously demonstrated [progression-free survival (PFS)] benefit that we had published persists,” Goetz said.

A total of 493 women were randomly assigned 2:1 to receive abemaciclib plus an NSAI (n = 328) or placebo plus an NSAI (n = 165). After a median follow-up of 8.1 years, 7% of patients were still receiving treatment in the abemaciclib arm vs 3% in the placebo arm. In the intent-to-treat (ITT) population, 314 OS events were observed, including 198 deaths among 328 patients (60%) in the abemaciclib arm and 116 deaths among 165 patients (70%) in the placebo arm (HR, 0.804).

The median OS was 66.8 months in the abemaciclib arm vs 53.7 months in the placebo arm, a numerical difference of 13.1 months in the ITT population. In the subgroup with visceral disease, 178 events were observed, including 113 deaths among 173 patients (65%) in the abemaciclib arm and 65 deaths among 90 patients (72%) in the placebo arm (HR, 0.758).

“With a median follow-up of a little over 8 years, abemaciclib in combination with an [aromatase inhibitor] resulted in numerically longer survival compared with an [aromatase inhibitor] alone,” Goetz said. “However, statistical significance was not reached.”

In the subgroup with visceral disease, median OS was 63.7 months in the abemaciclib arm and 48.8 months in the placebo arm, with a numerical difference of 14.9 months. Consistent OS differences were observed across prespecified subgroups, and PFS benefit was sustained (median PFS of 29.0 vs 14.8 months; HR, 0.535), with substantial difference in 6-year PFS rates (23.3% vs 4.3% for abemaciclib vs placebo, respectively).

Investigators also noted that chemotherapy-free survival improved with abemaciclib vs placebo (median chemotherapy-free survival of 46.7 vs 30.6 months; HR, 0.693). No new safety signals were observed with longer-term use. “These data are consistent with the totality of the data demonstrated with abemaciclib in the adjuvant as well as the neoadjuvant setting,” Goetz said during the presentation.

Goetz pointed out that this was the smallest of all the CDK4/6 trials, with just 493 patients, and the ability to examine survival was also limited by 2:1 randomized assignment. “As we look at these data, we have to acknowledge that they are not statistically significant,” Goetz said. “But we need to interpret them in light of those caveats.”


Goetz M. MONARCH 3: final overall survival results of abemaciclib plus a nonsteroidal aromatase inhibitor as first-line therapy for HR+, HER2- advanced breast cancer. Presented at: San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX.

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