Arvinas, Inc. (NASDAQ: ARVN) has provided an update on its guidance for first* and second-line phase 3 combination trials with vepdegestrant, along with highlighting upcoming milestones and a corporate update. The company is on track to report topline results from its first phase 3 trial in the first quarter of 2025 and to initiate two additional phase 3 trials by the end of the year.
In 2025, Arvinas and Pfizer plan to announce topline data for the veritac-2 phase 3 monotherapy clinical trial in patients with second-line-plus ER+/HER2 metastatic breast cancer in the first quarter. They also plan to initiate two new phase 3 combination trials in patients with ER+/HER2 MBC. This includes a first-line phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib, and a second-line phase 3 combination trial with a CDK4/6 inhibitor.
The prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting has led to the decision that the veritac-3 trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in.
Arvinas also plans to present the first-in-human data from arv-102, its protac LRRK2 degrader, in the first half of 2025, which they believe will highlight the potential value that their protac degraders may offer for patients with neurodegenerative diseases. They also intend to share initial data from their phase 1 trial with arv-393, their protac BCL6 degrader, which will provide an early look at the tolerability and efficacy in patients with B-cell lymphomas.
The company recently initiated a phase 1 trial with protac LRRK2 degrader arv-102 in patients with Parkinson’s disease. Additionally, they anticipate data disclosures from multiple clinical and pre-clinical programs, including arv-102 and arv-393, and plan to submit an investigational new drug (IND) application for a protac KRAS G12D degrader in 2025.
Alex Santini has been appointed interim chief commercial officer, effective January 17, 2025, bringing with him over 30 years of experience managing and leading commercial organizations. John Northcott, the previous chief commercial officer, is leaving the company for personal reasons, effective January 17, 2025.
Vepdegestrant, 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/HER2-negative breast cancer, is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; both companies will share worldwide development costs, commercialization expenses, and profits.
The U.S. Food and Drug Administration (FDA) has granted vepdegestrant fast track designation as a monotherapy in the treatment of adults with ER-positive/HER2-negative locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its protac protein degrader platform, the company is pioneering the development of protein degradation therapies designed to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, arv-393, and arv-102. Following these announcements, the company's shares moved -3.0%, and are now trading at a price of $19.23. Check out the company's full 8-K submission here.
