Incyte (INCY) investor relations material

Pipeline and clinical development updates

• Phase III trial for mutant CALR antibody 989 in essential thrombocythemia (ET) to start mid-year, featuring an all-comer design and 24-week primary endpoint, with VAF as a secondary endpoint.

• Substantive EHA update for 989 in ET includes data from 110 patients, showing 92% response in type one mutations and 30-40% in non-type ones.

• Second-line ET registration studies will use IV formulation initially, aiming for launch in 2029, with subQ formulation available within six months post-launch.

• Myelofibrosis (MF) program seeks regulatory alignment on composite endpoints, with ongoing discussions with FDA and data updates expected in the third quarter.

• V617F program faces formulation challenges; next-gen and partnered options are being pursued if current asset underperforms.

Regulatory and study design insights

• FDA collaboration enabled a shortened primary endpoint for ET studies, measuring hematologic control at 24 weeks instead of 52.

• Composite endpoints in MF, including hemoglobin, blast count, platelets, and spleen, are under consideration for better correlation with survival.

• Control arms in MF studies will include a broad range of therapies, with dosing strategies potentially tailored by mutation type.

• VAF reduction is being validated as a molecular endpoint in both ET and MF studies.

Competitive landscape and innovation

• EHA presentations will include MF oral, ET poster, and translational poster with single-cell sequencing data.

• Competitor Ajax shows promising SVR and symptom data, but mutation-specific therapies are seen as the future.

• SubQ formulation development leverages the enFuse device, targeting high bioavailability and patient convenience.

• Next-gen assets and external partnerships (e.g., Prelude) are in place to ensure pipeline continuity.