On November 28, 2023 Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) reported that updated clinical trial data for vepdegestrant (ARV-471) will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) (Press release, Arvinas, NOV 28, 2023, View Source [SID1234638016]). Vepdegestrant is a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader currently being investigated for the potential treatment of patients with locally advanced or metastatic estrogen receptor (ER) positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Arvinas and Pfizer are collaborating to develop and commercialize vepdegestrant.
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Data from the Phase 1b study assessing vepdegestrant in combination with palbociclib (IBRANCE) will be presented in a spotlight session on December 7, 2023. An update on the Phase 2 vepdegestrant monotherapy (VERITAC) study will be presented in a poster presentation alongside four other posters during the symposium held from December 5-9, 2023, in San Antonio, Texas.
Session details are as follows in chronological order. For more information, visit the official SABCS website here.
VERITAC-2 Trial in Progress
Poster Session 1 (ID: PO1-19-12)
Wednesday, December 6, 12:00-2:00 PM CT
VERITAC-2: a Phase 3 study of vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, vs fulvestrant in ER–positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
Mario Campone
VERITAC-3 Study Lead-in Trial in Progress
Poster Session 2 (ID: PO2-20-03)
Wednesday, December 6, 5:00-7:00 PM CT
VERITAC-3: A randomized Phase 3 study, with a lead-in, of first-line vepdegestrant + palbociclib vs letrozole + palbociclib in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer
Seth Wander
TACTIVE-U Trial in Progress
Poster Session 2 (ID: PO2-20-04)
Wednesday, December 6, 5:00-7:00 PM CT
TACTIVE-U: Phase 1b/2 umbrella study of vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, combined with other anticancer treatments in ER–positive advanced or metastatic breast cancer
Claudine Isaacs
Vepdegestrant Monotherapy (VERITAC) Update
Poster Session 3 (ID: PO3-05-08)
Thursday, December 7, 12:00-2:00 PM CT
Updated results from VERITAC evaluating vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
Sara Hurvitz
Vepdegestrant + Palbociclib Phase 1b
Spotlight Session: Novel nuclear receptor targeting therapies (ID: PS15-03)
Thursday, December 7, 5:30-6:30 PM CT
Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, plus palbociclib in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer: phase 1b cohort
Erika Hamilton
Pharmacokinetic/Pharmacodynamic Modeling of Palbociclib
Poster Session 5 (ID: PO5-14-11)
Friday, December 8, 12:00-2:00 PM CT
Leveraging a pharmacokinetic/pharmacodynamic (PK/PD) model to guide dose optimization of palbociclib in combination with Vepdegestrant
Brian Jermain
About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits. Ongoing and planned clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant.