INCY - Dinner with Mgmt Highlights Confidence in mCALR Opp'ty in ET & MF; Numerous Pipeline Readouts in 2H26; Palpable Enthusiasm on KRAS G12D & PD-1xTGFb Programs

研报英文原文证据摘录

INCY - Dinner with Mgmt Highlights Confidence in mCALR Opp'ty in ET & MF; Numerous Pipeline Readouts in 2H26; Palpable Enthusiasm on KRAS G12D & PD-1xTGFb Programs

BIOTECHNOLOGY

INCYTE CORPORATION June 16, 2026

the initial disclosure at ASH 2025 (see here), the company commented that it was likely a

result of increased enrollment in the lower dose cohorts, with relatively few patients enrolled

in the upper dose cohorts (i.e., RP3D) where most patients also had not reached follow-

up week 24 at the EHA data-cut. Additionally, mgmt emphasized that 61% of patients on

their study did not have prior JAKi washout, where historical trials have shown significantly

lower SVR35 in patients without washout compared to those with washout (momelotinib's

7% without washout [SIMPLIFY-2] vs. 22% with washout [MOMENTUM]).

FDA discussions regarding Ph 3 trial for '989 in 2L MF have commenced and will focus

on alignment on a potential composite endpoint that is more predictive of increased

OS. INCY has begun discussions with the FDA regarding a potential pivotal Ph 3 design in 2L

MF, where mgmt highlighted potential incorporation of anemia responses into the endpoint

framework, citing support from KOLs in addition to independent datasets that suggest better

correlation with survival compared to SVR35, where we note a large meta-analysis shared

at ASH 2025 demonstrating non-anemia patients had lower risk of death compared to

anemic patients (see here) as well as a subgroup analysis from the SIMPLIFY-1 study of

momelotinib that also prioritized transfusion independence in anemic patients (Padandri

et al 2026). If a composite endpoint is adopted, mgmt feels "very comfortable winning all-

comers" MF patients; however, if a traditional SVR35/TSS50 endpoint is adopted, INCY may