OnCo
trialsTrialPositive

postMONARCH

Continuing CDK4/6 blockade with a different drug after the first one fails gives a small but real benefit.

PFS 6.0 vs 5.3 months (HR 0.73; P=0.017 nominal); the first placebo-controlled phase 3 showing benefit of CDK4/6 inhibition beyond progression. Absolute gain is modest; biomarker-defined subgroups (no ESR1 or PIK3CA mutation) did better.

Setting
HR+/HER2- advanced breast cancer after progression on CDK4/6 + endocrine therapy: abemaciclib + fulvestrant vs placebo + fulvestrant
Phase
Phase 3
Sponsor
Eli Lilly
Registry
Headline result
PFS 6.0 vs 5.3 months, HR 0.73.
Reported
2024
Enrolled
368
Replication
Contrasts with the negative PACE and PALMIRA trials of continuing palbociclib; MAINTAIN (ribociclib switch) was positive in phase 2.

Outcomes

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In plain words
What these results mean for people, not percentages
368 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 6 vs 5.3 months with Abemaciclib + fulvestrant compared with Placebo + fulvestrant; about 0.7 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 27 percent lower chance of the event at any given time (hazard ratio 0.73, likely range 0.57 to 0.95).
  • 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.
  • These results apply to the people the trial enrolled: HR+/HER2- advanced breast cancer after progression on CDK4/6 + endocrine therapy: abemaciclib + fulvestrant vs placebo + fulvestrant. 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.

368 participants enrolled.

Progression-free survivalprimary
HR 0.73 (0.57–0.95) · p = 0.017
Abemaciclib + fulvestrant
6 mo
Placebo + fulvestrant
5.3 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryAbemaciclib + fulvestrant1826 months0.73 (0.57–0.95)0.017link
Placebo + fulvestrant1865.3 months
Replication
Contrasts with the negative PACE and PALMIRA trials of continuing palbociclib; MAINTAIN (ribociclib switch) was positive in phase 2.

Connected

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