Arvinas, Inc. and Pfizer Inc. announced preliminary data from the Phase 1b portion of the TACTIVE-U sub-study, evaluating vepdegestrant in combination with abemaciclib. The study focused on patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer who had previously been treated with a CDK4/6 inhibitor.
Preliminary results from 16 patients demonstrated an encouraging clinical benefit rate of 62.5% and an overall response rate of 26.7%. The combination exhibited a tolerable safety profile, consistent with the known characteristics of abemaciclib and prior observations for vepdegestrant.
Pharmacokinetic data showed no significant drug-drug interaction between vepdegestrant and abemaciclib. The recommended Phase 2 dose was identified as 200 mg once daily for vepdegestrant and 150 mg twice daily for abemaciclib, supporting further development in this patient population.
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