TheChek News Flow

• Lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome
• In addition, Innate’s ANKETTM (Antibody-based NK cell Engager Therapeutics) platform on display at ASH via oral presentation and posters

Presented data from a preliminary analysis of the TELLOMAK Phase 2 trial demonstrating clinical activity and a favorable safety profile for lacutamab, a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, in patients with advanced Sézary syndrome, a form of T cell lymphoma. The data were presented during the 2022 ASH (American Society Hematology) Annual Meeting, in New Orleans (United States).

At the time of data cut off (April 29, 2022), the Intention To Treat (ITT1) population included 37 post mogamulizumab patients with advanced, highly refractory Sézary syndrome, and 35 patients were Evaluable for Efficacy (EES2). The patient population was heavily pre-treated with a median of 6 prior lines of therapy. The median follow-up was 10.9 months.

In the ITT population, the global objective response rate (ORR) was 21.6% (8/37). ORR in the blood was 37.8% (95% confidence interval (CI): 24.1-53.9), with 21.6% (8/37) achieving complete response (CR). ORR in the skin was 35.1% (95% CI: 21.8-51.2). In the EES population, global objective response rate (ORR) was 22.9% (8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in the skin was 37.1% (95% CI: 23.2-53.7).

Within the subgroup of patients that achieved a global response, median duration of global response was 10.8 months (95% CI: 6.2-12.3) with median time to global response of 4 months (range: 1.0-6.5); median time to blood response was 1.0 month (range: 1.0-6.5) and median time to skin response was 2.8 months (range: 0.9-10.2).

In line with previous observations, lacutamab demonstrated a favorable safety profile for patients with advanced Sézary syndrome in the TELLOMAK Phase 2 preliminary analysis. Grade = 3 Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs) were observed in 6/37 (16.2%) patients. Most common TR TEAEs were general disorders and administration site conditions (N=6, 16.2%), skin and subcutaneous tissue disorders (N=5, 13.5%), and gastrointestinal disorders (N=3, 8.1%).

CMO: “This encouraging preliminary analysis in Sézary syndrome adds to the encouraging cutaneous T-cell lymphoma data we previously shared within the Phase 1 study, and Phase 2 mycosis fungoides cohort. The data continues to support our fast to market strategy for lacutamab in the niche setting of Sézary syndrome where lacutamab was granted U.S. Fast Track designation and EU Prime designation. We look forward to final data in 2023 while we continue investigate the role of lacutamab in other T-cell lymphomas including the monotherapy and combination trials for peripheral T-cell lymphoma.”

- Pr. Vivier, DVM, PhD, Chief Scientific Officer: “Progress continues toward investigational new drug (IND) filing in 2023 for our latest innovation, Innate’s CD20 targeted tetra-specific ANKETTM, IPH6501.”