A clinical benefit rate of 62.5% was noted among subjects with both mutant and wild-type oestrogen receptor alpha gene disease. Credit: Andrei_R/Shutterstock.

Arvinas and Pfizer have shared preliminary outcomes from the Phase Ib segment of the TACTIVE-U sub-trial of vepdegestrant plus abemaciclib for treating individuals with locally advanced or metastatic, oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer.

The combination demonstrated a tolerable safety profile, as per the ongoing trial’s preliminary data involving 16 subjects.

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They received 150mg of abemaciclib two times a day, alongside the recommended Phase III monotherapy vepdegestrant dose of 200mg once a day.

A clinical benefit rate of 62.5% was noted among subjects with mutant and wild-type oestrogen receptor 1 (ESR1) disease, all of whom had previously been treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

No significant drug-drug interactions were observed between vepdegestrant and abemaciclib, according to the pharmacokinetic data.

A clinically meaningful effect on abemaciclib exposure also was not observed. The safety profile demonstrated was consistent with the known properties of abemaciclib, and with data from other vepdegestrant trials.

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These outcomes support the advancement to the Phase II segment of the trial, which will evaluate the full dose of abemaciclib and vepdegestrant in post-CDK4/6 advanced breast cancer.

Ongoing evaluations of the TACTIVE-U clinical trial by both companies include various combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib.

Arvinas chief medical officer Noah Berkowitz said: “The preliminary results from this Phase Ib sub-study in patients whose cancer had previously progressed after receiving a CDK4/6 inhibitor are encouraging.

“These data further reinforce our belief that vepdegestrant can be used in multiple combination regimens across the metastatic breast cancer setting, and has the potential to become a best-in-class backbone ER therapy.“

An orally bioavailable Proteolysis Targeting Chimera (PROTAC) protein degrader, vepdegestrant is being developed for potential use as both a single agent and as part of a combination therapy for ER+/HER2- metastatic breast cancer.

In October this year, Pfizer released positive topline results from the Phase III TALAPRO-2 trial of TALZENNA plus XTANDI (enzalutamide) for individuals with metastatic castration-resistant prostate cancer (mCRPC).