marked.bio

oral SERD ยท small molecule

camizestrant

2 active trials across 2 of our biomarkers, targeting ER. 1 active approval for a biomarker on marked.bio.

Also known as AZD9833.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
camizestrant with CDK4/6 inhibitor
FDA, 2026
locally advanced or metastatic, ESR1 mutation emerging during first-line aromatase inhibitor + CDK4/6 inhibitor; switch while continuing the CDK4/6 inhibitor FDA accelerated approval 04/09/2026; companion test Guardant360 CDx (blood monitoring). Source
Etcamah 		ESR1 mutation breast (HR+/HER2-) Approved 2026 accelerated Not approved

SERENA-6 vs continue aromatase inhibitor + CDK4/6 inhibitor, 315 randomised (1:1)
PFS 16.0 months vs 9.2 months, HR 0.44 (0.31-0.60)

Serious side effects 10%Stopped for side effects 1.3%Fatal 1.3%

Trial details and side effects
Patients
ESR1 mutation found by blood monitoring during first-line AI + CDK4/6 inhibitor, before progression (NCT04964934)
Most common side effects
visual disturbances 34%, fatigue 23%, arthralgia 16%, dry eye 12%, back pain 10%, nausea 10%, low neutrophils 68% (with the CDK4/6 inhibitor) (155 patients)
Notes
FDA approval summary (2026); OS immature. Boxed warning: QTc prolongation with other QT-prolonging drugs. Side effects: Etcamah US label, section 6 (SERENA-6).
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 1 1 Phase 3
ESR1 mutation 1 1 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of camizestrant.

  1. AstraZeneca 2

Trials

2 of 2 trials shown

  1. Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

    Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2029-12 NCT06380751

    saruparibcamizestrantabemaciclibribociclibpalbociclibfulvestrantletrozoleanastrozoleExemestane

    Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2

    BRCA1/2 mutationAdvanced Breast Cancer

  2. Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2025-06 NCT04964934

    camizestrant FDAanastrozoleletrozolepalbociclibabemaciclib FDALuteinizing hormone-releasing hormone (LHRH) agonistribociclib

    Have an ESR1 mutation in their cancer;

    ESR1 mutationER-Positive HER2-Negative Breast Cancer