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.
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.
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
View profiles in store
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
Tick here to opt out of curated industry news, reports, and event updates from Clinical Trials Arena.
Submit and
download
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
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).
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.