Pfizer(PFE.US)Potential "First-in-Class" Small Molecule Combination Therapy Achieves Primary Endpoint

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Pfizer (PFE.US) announced on March 18th that its Phase 2 FOURLIGHT-1 study has met its primary endpoint. The results show that its small molecule therapy atirmociclib combined with fulvestrant significantly improved progression-free survival (PFS) compared to active control in patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (MBC) who had previously received CDK4/6 inhibitors.

This positive result supports Pfizer’s strategy to advance atirmociclib in first-line treatment and early-stage disease, aiming for more durable endocrine therapy control and greater clinical benefits in these populations. Currently, a Phase 3 registration study of atirmociclib for first-line metastatic breast cancer is underway, and results from a Phase 2 study in neoadjuvant treatment of early breast cancer are also upcoming.

Atirmociclib is an investigational, potential first-in-class oral CDK4 inhibitor. CDK4 is a key regulator of the cell cycle that drives cell proliferation. Discovered by Pfizer, it is currently being developed for HR-positive, HER2-negative breast cancer.

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