Incyte (INCY) Status Update summary

Key clinical data and milestones

• Pivotal data presented for retifanlimab in squamous cell anal cancer, showing improved progression-free survival (PFS) and a strong trend toward better overall survival, establishing a new standard of care for advanced disease.

• Tafasitamab met its primary endpoint in follicular and marginal zone lymphoma, supporting potential label expansion.

• Axatilimab received FDA approval for chronic graft-versus-host disease, with launch preparations underway.

• Opzelura submission for pediatric atopic dermatitis remains on track.

• Four major milestones for 2024 have been achieved, with additional pivotal studies and regulatory submissions planned for 2025.

Retifanlimab in squamous cell anal cancer

• Phase 3 trial met its primary endpoint: median PFS of 9.3 months vs. 7.4 months for placebo, hazard ratio 0.63.

• Early separation of survival curves and a strong trend toward improved overall survival, with manageable safety profile.

• Disease control and response rates improved, with no new safety concerns and high tolerability.

• Retifanlimab expected to become standard of care for about 40% of advanced anal cancer patients.

CDK2 inhibitor program in ovarian and endometrial cancer

• Over 200 patients treated; majority with heavily pretreated ovarian or endometrial cancer.

• Selective CDK2 inhibitor demonstrated 24–31% response rate and 75% disease control rate in expansion cohorts.

• Responses are durable, with most ongoing and deepening over time; safety profile is favorable with few discontinuations.

• Companion diagnostic for cyclin E overexpression is in development, with over 50% of ovarian and 70% of endometrial cancers showing this biomarker.