Arvinas announces anticipated upcoming milestones

Vepdegestrant: Oral PROTAC ER degrader: As part of Arvinas (ARVN) global collaboration with Pfizer, the companies plan to: Announce topline data for the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in patients with ER+/HER2- metastatic breast cancer in a topline press release 1Q25 and present full results of the trial at a medical conference in 2025. Initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC in 2025: First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib. Second-line Phase 3 combination trial with a CDK4/6 inhibitor. With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 Phase 3 clinical trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in. Continue to collect safety and efficacy data from ongoing TACTIVE-U sub-studies evaluating combination of vepdegestrant with abemaciclib, ribociclib, or samuraciclib and submit key data for presentation at medical conference. Continue enrollment in the Phase 2 TACTIVE-K clinical trial and submit initial Phase 1b data for presentation at a medical conference. ARV-393: Oral PROTAC BCL6 degrader: Present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive diffuse large B-cell lymphoma in vivo models at the American Association for Cancer Research Annual Meeting. Disclose preliminary data from the ongoing Phase 1 clinical trial in patients with NHL in 2025. ARV-102: Oral PROTAC LRRK2 degrader: Present SAD data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease conference in Vienna, Austria demonstrating: Bioavailability and brain penetration with dose dependent exposure in cerebral spinal fluid. Degradation of LRRK2 in the periphery and CSF of healthy volunteers. Complete enrollment and present initial data from the ongoing SAD Phase 1 clinical trial in patients with PD in 2025; initiate MAD cohort in patients with PD in 2025. Novel PROTAC KRAS G12D degrader. File an Investigational New Drug application in 2025.