Pfizer Launches Second Phase III Trial of ER-Targeting PROTAC Vepdegestrant as First-Line Therapy for Breast Cancer

On June 19, Pfizer initiated the second Phase III clinical trial (VERITAC-3) of vepdegestrant (ARV-471/PF-07850327), aiming to evaluate vepdegestrant in combination with palbociclib compared to standard treatment (letrozole + palbociclib).First-line treatmentEfficacy and safety in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor-negative (HER2-) locally advanced or metastatic breast cancer. The primary endpoint of the study is progression-free survival (PFS).

The study plans to enroll 1,180 breast cancer patients who have not received any prior treatment. It is expected to commence on June 28, 2023, and conclude on July 26, 2030. Before the official start of the study, there will be a Study Lead-In (SLI) phase, during which the therapeutic effects of two doses of vepdegestrant will be evaluated in 50 patients to determine the recommended Phase III dose (R3PD).

Previously, Pfizer had initiated the first Phase III clinical trial of vepdegestrant, VERITAC-2, on December 16, 2022, aiming to evaluate vepdegestrant compared to fulvestrant.Second-line TreatmentEfficacy and Safety in ER+/HER2- Advanced Breast Cancer Patients.

Vepdegestrant is an orally available, ER-targeting protein degrader (PROTAC) developed by Arvinas, which can induce the degradation of both wild-type and mutant ER.

In July 2021, Pfizer acquired the global rights to this product in a deal potentially worth up to $2.05 billion. In endocrine-sensitive and resistant xenograft models, vepdegestrant demonstrated superior ER degradation and antitumor activity compared to fulvestrant. Additionally, the combination of vepdegestrant and palbociclib showed significant synergistic effects, effectively reducing tumor growth.

In addition to Pfizer, the ER PROTAC (HRS-1358) developed by Hengrui has also entered the clinical stage and is currently undergoing Phase I clinical trials. We look forward to more positive news from the PROTAC field in the future.

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