Innate Pharma Reports Positive TELLOMAK Phase 2 Results for Lacutamab in Mycosis Fungoides

Innate Pharma SA recently unveiled promising results from its Phase 2 TELLOMAK study assessing the efficacy of lacutamab for treating mycosis fungoides (MF). This data, shared at the ASCO 2024 Annual Meeting in Chicago, underscores lacutamab’s potential as an effective treatment for heavily pretreated MF patients, regardless of their baseline KIR3DL2 expression levels.

The study involved 107 MF patients who had undergone a median of four prior systemic therapies and were followed for a median of 11.8 months. The findings indicate that lacutamab exhibited significant antitumor activity and maintained a favorable safety profile, with an overall objective response rate (ORR) of 16.8% (Olsen 2011 criteria) and 22.4% (Olsen 2022 criteria). These responses included two complete responses and sixteen partial responses. Specifically, for patients with baseline KIR3DL2 expression levels of 1% or higher, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival (PFS) for the entire cohort was 10.2 months, whereas it extended to 12.0 months for those in the KIR3DL2 ≥ 1% group. The median time to response was one month.

Dr. Sonia Quaratino, Innate Pharma’s Chief Medical Officer, emphasized the clinical significance of these outcomes for patients with limited treatment options. Prof. Pierluigi Porcu of Jefferson Health, a principal investigator in the study, echoed these sentiments, highlighting lacutamab’s efficacy and tolerability in a demographic with few effective therapies.

The study’s detailed results include:
- An ORR of 16.8% (Olsen 2011) and 22.4% (Olsen 2022) across all MF patients.
- For the KIR3DL2 ≥ 1% subgroup, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022).
- Median PFS of 10.2 months for all patients, with 12.0 months for the KIR3DL2 ≥ 1% group.
- Time to global response median of one month across the board.

The TELLOMAK trial is a global, open-label, multi-cohort Phase 2 study focused on Sézary syndrome and mycosis fungoides. The trial comprises several cohorts: one evaluating lacutamab in patients with Sézary syndrome who have received at least two prior therapies, one in MF patients expressing KIR3DL2, and another in those not expressing KIR3DL2. The primary endpoint is the objective global response rate, with secondary endpoints including progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics, immunogenicity, and adverse events.

Lacutamab, the subject of this study, is an innovative humanized cytotoxicity-inducing antibody targeting KIR3DL2. It has received PRIME designation from the European Medicines Agency (EMA) and Fast Track designation from the US Food and Drug Administration (FDA) for treating relapsed or refractory Sézary syndrome in patients who have undergone at least two prior systemic treatments. Lacutamab has also been granted orphan drug status in both the EU and the US for treating cutaneous T-cell lymphoma (CTCL).

Innate Pharma is a clinical-stage biotechnology firm based in Marseille, France, with a US office in Rockville, MD. The company specializes in developing immunotherapies for cancer, leveraging its expertise in harnessing the innate immune system through therapeutic antibodies and the ANKET® platform. Innate Pharma’s portfolio includes lacutamab, monalizumab (developed with AstraZeneca), and other multi-specific NK cell engagers targeting various tumor types.