Innate Pharma (IPH) Study Result summary

Study background and design

• TELLOMAK is a phase II, multi-cohort, global, open-label study evaluating lacutamab monotherapy in relapsed/refractory mycosis fungoides (MF) and Sézary syndrome after at least two prior systemic therapies.

• 107 MF patients were enrolled, stratified by KIR3DL2 expression (≥1% or <1%), with central pathology review for cohort assignment.

• Patients were heavily pretreated, with a median of 4 prior systemic therapies and a median follow-up of 11.8 months.

• The primary endpoint was global objective response rate (ORR); secondary endpoints included progression-free survival (PFS), duration of response, quality of life, safety, and pharmacokinetics.

• Lacutamab is a first-in-class anti-KIR3DL2 monoclonal antibody, granted orphan drug, PRIME (EMA), and Fast Track (FDA) designations.

Efficacy results

• Global ORR in all MF patients was 16.8% (95% CI: 10.9, 25.0); higher in KIR3DL2 ≥1% (20.8–29.2%) vs <1% (13.6%).

• Median PFS for all MF patients was 10.2 months (95% CI: 6.5, 16.8); 12.0 months for KIR3DL2 ≥1% and 8.5 months for <1%.

• Median time to global response was 1.0 month for KIR3DL2 ≥1% and 1.9 months for <1%.

• Skin response rates were 29–33.3% overall, higher in KIR3DL2 ≥1% subgroup.

• Early and deep responses were observed regardless of KIR3DL2 expression.

Safety and tolerability

• Lacutamab was well-tolerated, with a safety profile consistent with prior studies and no new safety signals or delayed toxicities.

• 90.7% of patients experienced at least one treatment-emergent adverse event (TEAE); 24.3% had grade ≥3 TEAEs.

• Most common related TEAEs: fatigue (11.2%), nausea (11.2%), asthenia (10.3%), arthralgia (10.3%), diarrhea (6.5%).

• TEAEs led to discontinuation in 5.6% of patients; related TEAEs in 2.8%.

• No unexpected toxicities or autoimmune manifestations were reported.