On September 22, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported an encore presentation of interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated guidelines (Olsen 20221) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023, being held September 21-23, 2023 in Leiden, the Netherlands (Press release, Innate Pharma, SEP 22, 2023, View Source [SID1234635335]). The data confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody.

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The data were previously presented at the 17th International Conference on Malignant Lymphoma, in Lugano (Switzerland), in June 2023.

As of March 4, 2022, data cutoff, patients in the KIR3DL2-expressing MF cohort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months. In the KIR3DL2 non-expressing cohort (cohort 3, n=18), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months.

Lymph Node assessment is an important component of staging and response assessment in CTCL (cutaneous T cell lymphomas). In a recent update to the Olsen 2011 guidelines, it was clarified that the pathological assessment of lymph nodes be limited to those that satisfy nodal lymphoma i.e. N3 designation1.

Based on these criteria, results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc]. In Cohort 3, comprising 18 patients with KIR3DL2 < 1% MF, findings remain unchanged.

"We are pleased to present the interim results of the Phase 2 TELLOMAK study based on updated guidelines at the EORTC Cutaneous Lymphoma Tumour Group Meeting. We are encouraged by the data demonstrating a 42.9% ORR and 9 responses in KIR3DL2 expressing mycosis fungoides patients, a heavily treated population, based on updated guidelines," said Dr. Joyson Karakunnel, Interim Chief Medical Officer of Innate Pharma. "These data confirm the previously observed clinical activity with lacutamab in this population and we look forward to the final results from the Phase 2 TELLOMAK trial in the second half of the year."

Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris, and investigator in the TELLOMAK study, added: "Lymph Node assessment is a key component of staging and response assessment in CTCL, and the community recognizes the importance of the adoption of latest guidelines. The higher global ORR according to updated lymph node further supports the ongoing development of lacutamab in T cell lymphomas. We thank the investigators, clinical research coordinators, patients and caregivers involved in the ongoing TELLOMAK program."

Summary of Preliminary Efficacy Results in Cohort 2 (KIR3DL2 ≥ 1%):

Best

Response

in Skin

N=21

Best

Response

in Blood

N=8

Best Global

Response

N=21

Olsen 2011

(N1, N2, N3, Nx involved)

Olsen 2022

(N3 lymphoma involved )

Best Response (N)

CR

2 (9.5%)

5 (62.5%)

2 (9.5%)

2 (9.5%)

PR

10 (47.6%)

0 (0%)

4 (19%)

7 (33.3%)

SD

7 (33.3%)

3 (37.5%)

13 (61.9%)

10 (47.6%)

PD

2 (9.5%)

0 (0%)

2 (9.5%)

2 (9.5%)

NE

ORR%

57.1%

62.5%

28.6%

42.9%

[95%CI]

[36.5-75.5]

[30.6-86.3]

[13.8-50.0]

[24.5-63.5]

Details of the presentation:

Title: Lacutamab in patients with mycosis fungoides: efficacy results according to updated lymph node classification in the TELLOMAK study
Presenter: Martine Bagot, Hôpital Saint Louis, Université Paris Cité, Inserm U976, Paris, France
Date and time: 23 September 2023, 9:22 – 9:34 CEST
About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.

About TELLOMAK:

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.
Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon 2-stage design.
All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic.
Overall, MF cohorts (cohort 2, cohort 3 and all comers) will enroll approximately 100 patients.

The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.