Arvinas (ARVN) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key upcoming milestones

• Anticipated phase III vepdegestrant readout expected late Q4 2024 or early Q1 2025, potentially marking the first approval for a protein degrader in oncology.

• Data from smaller combinability studies and next-generation programs, including BCL6 and LRRK2, will be available later this year and into next year.

• Multiple launches in breast cancer are targeted over the next five years, with up to three possible indications.

• LRRK2 degrader program in neurology is progressing, with human dosing underway and results expected next year.

Clinical trial expectations and regulatory strategy

• VERITAC-2 study uses co-primary endpoints for ESR1 mutant and overall populations, aiming for 2–3 months improved median PFS over fulvestrant.

• Prior studies (EMERALD, postMONARCH) inform expectations for control arm PFS between 2–4 months.

• Broader label possible if benefit-risk is positive in non-ESR1 mutant population, supported by a strong safety profile.

• Top-line results will focus on primary endpoints and safety, with timing dependent on event-driven trial maturity.

Commercial and market opportunity

• Multi-year plan includes monotherapy and combination therapy in second line, and first-line studies with potential for market consolidation.

• Second-line space is fragmented, with current regimens offering 2–8 months PFS; aim is to match or exceed this with monotherapy and combinations.

• Combination with CDK4/6 inhibitors could extend PFS to 8–10 months, depending on VERITAC-2 results.