AstraZeneca's Next-Gen Oral SERD Camizestrant Shows Positive Phase III Results in Combination with CDK4/6 Inhibitors for First-Line HR+ Advanced Breast Cancer with ESR1 Mutations

Feb 26, 2025 16:53 CST Updated 16:53

AstraZeneca

Biopharmaceutical Manufacturer

February 26AstraZeneca announced the SERENA-6 Phase III clinical trial,Camizestrant In first-line advanced HR-positive breast cancer(With ESR1 Tumor Mutation)Exhibited in patientsHighly statistically significant and clinically meaningfulImproved Progression-Free Survival. Specific data will be announced at the upcoming medical conference and shared with global regulatory agencies.

The press release pointed out,Camizestrant isThe First and Only Next-Generation Oral SERD with Complete ER Degradation, can bring benefits in first-line treatment when used in combination with widely recognized CDK4/6 inhibitors.

Screenshot source: Corporate official website

The interim analysis results show,Camizestrant With CDK4/6 Inhibitors(Palbociclib, Ribociclib, or Abemaciclib)Combined use,In Progression-Free Survival (PFS) This primary endpoint demonstrated a highly statistically significant and clinically meaningful improvement.。Key secondary endpoints PFS2 and OS are not yet mature.However, Camizestrant combination therapy has already shown a trend of PFS2 improvement.

SERENA-6 is a Phase III double-blind randomized trial designed to evaluateCamizestrant With CDK4/6 Inhibitors(Palbociclib, Ribociclib, or Abemaciclib)Combined therapy relative toAromatase Inhibitors(Anastrozole or Letrozole)Combination Therapy with CDK4/6 Inhibitors in HR-Positive, HER2-Negative Advanced Breast Cancer(Patients with locally advanced or metastatic breast cancer)And the efficacy and safety of tumors with ESR1 mutations.

The trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer who receivedAromatase InhibitorsCombination CDK4/6 inhibitor therapy as first-line treatment.The primary endpoint of the SERENA-6 trial is investigator-assessed PFS., secondary endpoints include OS and investigator-assessed PFS2.

It is worth mentioning that the trial is alsoThe first global double-blind Phase III clinical trial,Using Circulating Tumor DNA (ctDNA) Method for Detecting the Emergence of Endocrine Resistance, and inform about treatment transition before disease progression.

This novel trial design uses ctDNA testing at routine oncology scans to identify early signs of endocrine resistance and the emergence of ESR1 mutations in patients.After detecting ESR1 mutations but without disease progression, the patient's endocrine therapy was continued fromAromatase InhibitorsTreatment Conversion toCamizestrant , while continuing to be used in combination with the same CDK4/6 inhibitor.

Camizestrant is an investigational, potent next-generation oral SERD and complete ER degrader. AstraZenecaIncluding trials such as SERENA-6, SERENA-4, CAMBRIA-1, and CAMBRIA-2Camizestrant The safety and efficacy of using alone or in combination with other drugs to address many unmet medical needs in specific types of breast cancer.

Insight database shows that currently, globally, there are a total of 16 oral SERD drugs under research.EisaiElacestrant was approved for marketing by the FDA and EMA in 2023, respectively.Eli LillyImlunestrant is in the marketing application stage.

In addition, there are 6 drugs that have entered Phase III clinical trials, respectively fromSimcere, Innovent Biologics, AstraZeneca, Roche,Olema Pharmaceuticals and Sanofi。

Unfortunately, Sanofi's Amcenestrant has been terminated due to multiple study failures.All clinical trials of the Amcenestrant project, this oral SERD new drug have been terminated.

Screenshot source: Insight database

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