Incyte (INCY) Investor presentation summary

Study design and patient population

• Phase 3, global, double-blind, placebo-controlled study compared Tafa-Len-R-CHOP to R-CHOP in untreated high-risk DLBCL or HGBL patients aged 18–80 years.

• 899 patients were randomized; baseline characteristics were well balanced between arms, with a median age of 65 and 96.6% at Ann Arbor stage III/IV.

• Primary endpoint was progression-free survival (PFS); key secondary endpoints included event-free survival (EFS) and overall survival (OS).

Efficacy outcomes

• Tafa-Len-R-CHOP significantly improved PFS vs R-CHOP (HR 0.75, p=0.0194); 2-year PFS was 71.1% vs 62.9%.

• EFS was also improved (HR 0.79, p=0.0260); 2-year EFS was 65.0% vs 56.7%.

• Interim OS analysis showed a positive trend (HR 0.85, p=0.2703); 2-year OS was 84.1% vs 80.5%.

• PFS benefit was more pronounced in centrally confirmed lymphoma subtypes (HR 0.68, p=0.0035).

• Consistent PFS benefit observed across key subgroups, including cell-of-origin and risk categories.

Safety and tolerability

• Most patients experienced at least one treatment-emergent adverse event (TEAE); grade ≥3 TEAEs were higher with Tafa-Len-R-CHOP (86.7% vs 76.1%).

• Most frequent TEAEs included neutropenia, anemia, and peripheral neuropathy; serious febrile neutropenia was 13.3% vs 9.8%.

• Fatal TEAEs were balanced, though COVID-19 and sepsis were more frequent with Tafa-Len-R-CHOP.

• Delivery of R-CHOP backbone was not compromised by addition of Tafa-Len.