SNDX/INCY: 4Q Axatilimab 1L cGVHD Data Offer Underappreciated Downside Protection For Asymmetric 4Q Axatilimab IPF Event

研报英文原文证据摘录

SNDX/INCY: 4Q Axatilimab 1L cGVHD Data Offer Underappreciated Downside Protection For Asymmetric 4Q Axatilimab IPF Event

steroids in 1L cGVHD ahead of the Phase 3 data.

Interim Phase 2 safety data, already published, support the 4Q catalysts combined

with the already compelling axatilimab data in 3L+ patients. In 3L+ cGVHD, axatilimab

generated a 75% OR, establishing that CSF-1R inhibition remains active even after standard

cGVHD therapies have failed. Importantly, the benefit was durable: 60% of responders

remained alive without starting new systemic cGVHD therapy for at least 12m after

response, median treatment duration was 10.3m, and FFS was 17.3m at the RP3D. As

such, it always seemed like a good idea to bring axatilimab's efficacy to an earlier line of

therapy. This belief appears to have been reinforced by an important 1L Phase 2 interim

safety update at EBMT 2026 that provided a patient disposition chart that can be used

as a proxy for efficacy. At the October 2025 cutoff, only 5% (1/21) treated axatilimab

+ ruxolitinib patients had required new systemic cGVHD therapy versus 15% (3/20) on

ruxolitinib monotherapy and 35% (6/17) on steroid monotherapy. Also, the addition of

axatilimab did not meaningfully worsen the short-term ruxolitinib safety profile. As a result,

81% of patients stayed on therapy for axatilimab + ruxolitinib versus 70% with ruxolitinib

alone and 35% for steroids, though it should be noted that an additional 12% of patients

completed treatment and tapered off steroids. This dataset is directly relevant to the 1L

program in that it shows the ability for axatilimab to deepen responses, which physicians will

want to see for commercial viability in the 1L setting, but it also shows an initial look at ability