On June 16, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody (Press release, Innate Pharma, JUN 16, 2023, View Source [SID1234632744]). The data were presented at the 17th International Conference on Malignant Lymphoma, in Lugano, Switzerland.
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As of March 4, 2022, data cutoff, patients in the KIR3DL2-expressing MF cochort (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 designation (Olsen 20221).
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 see the improved ORR of lacutamab in KIR3DL2 expressing mycosis fungoides patients, confirming the previously observed clinical activity in this heavily treated population," said Dr. Joyson Karakunnel, Chief Medical Officer of Innate Pharma. "We look forward to final data from the TELLOMAK Phase 2 trial in both Sézary syndrome and mycosis fungoides in 2023 and progressing the two additional trials that are ongoing with lacutamab in Peripheral T cell lymphoma."
Dr. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, added: "The higher global ORR according to updated lymph node evaluation highlights the importance of the adoption of latest guidelines, and is welcomed by the CTCL community. Treatment options are limited for patients with CTCL and the updated assessment of the TELLOMAK trial adds to growing evidence supporting 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
PR
SD
PD
NE
2 (9.5%)
10 (47.6%)
7 (33.3%)
2 (9.5%)
–
5 (62.5%)
0 (0%)
3 (37.5%)
0 (0%)
–
2 (9.5%)
4 (19%)
13 (61.9%)
2 (9.5%)
–
2 (9.5%)
7 (33.3%)
10 (47.6%)
2 (9.5%)
–
ORR%
[95%CI]
57.1%
[36.5-75.5]
62.5%
[30.6-86.3]
28.6%
[13.8-50.0]
42.9%
[24.5-63.5]
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.