Arvinas (ARVN) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key upcoming milestones

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

• Combination study data for vepdegestrant with other agents, including abemaciclib, ribociclib, and CDK7 inhibitors, will be shared later this year and early next year.

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

• Next-generation programs, such as BCL6 and LRRK2, are advancing in the clinic, with LRRK2 data expected next year.

Clinical trial insights and expectations

• VERITAC-2 phase III 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, estimated between 2–4 months.

• Strong phase I results in both ESR1 mutant and wild-type populations support optimism for broader efficacy.

• Regulatory strategy focuses on ESR1 mutant as base case, but a broader label is possible if safety and efficacy trends are favorable in the overall population.

Commercial and strategic outlook

• Multi-year plan includes monotherapy and combination therapy in second line, and a first-line study with Pfizer's atirmociclib or possibly palbociclib.

• Second-line breast cancer market is fragmented, but strong monotherapy results could drive consolidation.

• Combination therapies aim to extend PFS up to 8–10 months, depending on results.

• Front-line combination decisions will depend on accumulating safety and efficacy data, with atirmociclib favored due to declining palbociclib use.