Arvinas and Pfizer Report Positive Phase 1b Data for Vepdegestrant Combination Therapy, Demonstrating Clinical Benefit in Over 60% of CDK4/6 Inhibitor-Resistant Breast Cancer Patients

Dec 11, 2024 08:00 CST Updated 08:00

Arvinas

Developer of drugs in the fields of oncology and neurodegenerative diseases

Pfizer

Pharmaceutical R&D Developer

▎WuXiEdited by Kant Content Team

Arvinas and Pfizer, Inc. announced preliminary data from the ongoing Phase 1b clinical trial TACTIVE-U sub-study today. The trial evaluates the efficacy and safety of the protein degrader vepdegestrant in combination with the CDK4/6 inhibitor abemaciclib for the treatment of patients with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. All patients had previously been treated with a CDK4/6 inhibitor. Preliminary results from 16 patients in the Phase 1b sub-study showed,Abemaciclib (150 mg, twice daily) and the recommended dose for the Phase 3 clinical trial (200 mg, once daily)vepdegestrantThe combination therapy demonstrated an acceptable safety profile, with a patient clinical benefit rate of 62.5%.

Vepdegestrant is an investigational protein degrader with oral bioavailability, designed to target the degradation of estrogen receptors as a monotherapy or part of a combination therapy for the treatment of ER+/HER2- breast cancer patients.

Preliminary clinical trial results show:

The overall tolerability of the combination therapy was consistent with the known safety profile of abemaciclib and the previously observed results of vepdegestrant in other clinical trials. The most common treatment-emergent adverse events (TEAEs) of any grade were diarrhea, nausea, and fatigue. No dose-limiting toxicity was observed, and there were no Grade 4 or 5 TEAEs.
No significant drug interactions were found, and the data show that vepdegestrant has no clinically meaningful impact on abemaciclib exposure.
The initial antitumor activity is encouraging,The clinical benefit rate of patients (defined as the proportion of patients with confirmed complete response, partial response, or stable disease lasting ≥24 weeks) was 62.5%; the clinical benefit rate was 62.5% for both mutant ESR1 patients (5/8) and wild-type ESR1 patients (5/8).
The objective response rate (ORR) was 26.7% (4/15) in the evaluable patients; 37.5% (3/8) in patients with mutant ESR1 and 14% (1/7) in patients with wild-type ESR1.
As of August 30, 2024, five patients were still undergoing treatment.

In July 2021, Arvinas announced a global collaboration with Pfizer to jointly develop and commercialize vepdegestrant. The U.S. FDA has granted Fast Track designation to vepdegestrant as a monotherapy for the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer who have been previously treated. These clinical trial results support the ongoing Phase 2 clinical trial of this combination therapy.

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References:

[1] Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Sub-Study of Vepdegestrant in Combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium. Retrieved December 10, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994631/0/en/Arvinas-and-Pfizer-Announce-Initial-Phase-1b-Data-from-the-TACTIVE-U-Sub-Study-of-Vepdegestrant-in-Combination-with-Abemaciclib-at-2024-San-Antonio-Breast-Cancer-Symposium.html

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