Asset profile

Atirmociclib

Small molecule

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Phase 3underway

Evidence outlook · registrational

HR+/HER2- Metastatic Breast Cancer: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2029-01-02.

NCT06465368: The study randomized 121 participants to PF-07220060 plus letrozole or letrozole alone, but it was open-label, with only the biopsy assessment performed centrally in a blinded manner. Its primary endpoint was a Ki-67-based biomarker rather than a clinical outcome, and although the reported percentages favored the combination, statistical significance for the primary comparison was not stated.

Also in development:Non-Small Cell Lung Cancer · Phase 2

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Competitive landscape

119 competitors in this universe: 4 direct rivals (same mechanism and indication), 0 same-class, 115 same-indication; 82 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Atirmociclib: this drugPhase 3Small moleculeCDK4
BGB-43395Phase 3Small moleculeCDK4
HRS-6209Phase 2Small moleculeCDK4
SHR-6209Phase 2Small moleculeCDK4
AVZO-023Phase 1/2Small moleculeCDK4
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alpelisib (BYL719)ApprovedSmall moleculePI3K-alpha
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AnastrozoleApprovedSmall moleculeAromatase
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor

…and 104 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(9 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-31 · NCT06239467 · CT.gov ↗
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2027 (5)
February 2027 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT05262400 · CT.gov ↗
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April 2027 (1)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04-30 · NCT05216432 · CT.gov ↗
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August 2027 (1)
Phase 1Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy AdultsRecruiting
Est. primary completion 2027-08-14 · NCT07677358 · CT.gov ↗
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December 2027 (2)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-28 · NCT07427394 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-12-31 · NCT05508906 · CT.gov ↗
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2029 (2)
January 2029 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2029-01-02 · NCT06760637 · CT.gov ↗
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July 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-07-13 · NCT04606446 · CT.gov ↗
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2030 (1)
September 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 2 (5)
Phase 1/2 (3)
Phase 1 (10)