trialsTrialActive

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

A phase 3 trial of Abemaciclib and Fulvestrant in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer is a phase 3 interventional study registered as NCT02763566 by Eli Lilly and Company, with 463 participants enrolled, started 2016-12-05 and due to reach its primary completion in 2019-03-29. Interventions recorded: Abemaciclib, Anastrozole, Letrozole, Placebo and Fulvestrant. Results have been posted on the registry.

Setting

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

Phase

Phase 3

Sponsor

Eli Lilly and Company

Registry

Started

2016-12-05

Reported

2020

Enrolled

463 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

463 enrolled

Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)primarysurrogate endpoint

Median 14.7 months with Placebo + NSAI.
Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI): Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication.
A median is a midpoint: half the people did better than this and half did worse.
Put another way, the treated group had about 50 percent lower chance of the event at any given time (hazard ratio 0.499, likely range 0.346 to 0.719).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication.

Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]response endpoint

56 vs 30.3 out of 100 had their tumour shrink with Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) compared with Placebo + NSAI; 25.7 more per 100.
Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Abemaciclib + Fulvestrant 38.5 of 100; Placebo + Fulvestrant 7.5 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer. People in a different situation may not see the same effect.
The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

463 enrolled.

Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)primary

HR 0.499 (0.346 to 0.719) · p = 0.0001

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Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication · 95% CI 11.21 to 18.87

Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)56 of 100

n = 207

Placebo + NSAI30.3 of 100

n = 99

Abemaciclib + Fulvestrant38.5 of 100

n = 104

Placebo + Fulvestrant7.5 of 100

n = 53

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95% CI 49.3 to 62.8; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication · 95% CI 21.3 to 39.4 · 95% CI 29.1 to 47.8 · 95% CI 0.4 to 14.7

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)primary	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)	207	Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication	0.499 (0.346 to 0.719)	0.0001	link
	Placebo + NSAI	99	14.73 months	0.499 (0.346 to 0.719)	0.0001	link
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)	207	56%	-	-	link
	Placebo + NSAI	99	30.3%
	Abemaciclib + Fulvestrant	104	38.5%
	Placebo + Fulvestrant	53	7.5%

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cancers

Metastatic cancer (cancer that has spread)

technologies

CDK4/6 inhibitors Endocrine therapy (SERMs, AIs, SERDs)

drugs

ApprovedSmall-molecule CDK4/6 inhibitor

Abemaciclib · Verzenio

ApprovedOral non-steroidal aromatase inhibitor

Anastrozole · Arimidex

ApprovedInjectable SERD

Fulvestrant · Faslodex

companies

Eli Lilly (incl. Loxo)