ASCO 2023 | PF-07220060 in HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy

Timothy Yap, MBBS, PhD, FRCP, The University of Texas MD Anderson Cancer Center, Houston, TX, provides an overview of a first-in-human first-in-class Phase I/IIa study (NCT04557449).of the next generation CDK4-selective inhibitor PF-07220060 in patients with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy. The study included patients with HR+/HER2- advanced or metastatic breast cancer (mBC) who had received at least two lines of treatment, including prior endocrine therapy and CDK4/6 inhibitors, as well as patients with other solid tumors. PF-07104091 was administered orally twice daily in 28-day cycles, and the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) were determined. The primary objective was to assess safety and tolerability, while secondary objectives included pharmacokinetics and preliminary anti-tumor activity. The study found that PF-07104091 monotherapy was generally well tolerated, with observed antitumor activity in heavily pretreated patients with HR+ HER2- mBC who had progressed on prior CDK4/6 inhibitors. The study is ongoing with dose expansions of PF-07104091 as monotherapy in ovarian cancer patients and in combination with fulvestrant in breast cancer patients. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.

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