INNATE PHARMA PRESENTS DATA FROM ONGOING PHASE 2 TELLOMAK TRIAL DEMONSTRATING CLINICAL ACTIVITY OF LACUTAMAB IN ADVANCED MYCOSIS FUNGOIDES
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that lacutamab, an anti-KIR3DL2 antibody, demonstrated clinical responses in patients with mycosis fungoides (MF), in the ongoing Phase 2 TELLOMAK clinical trial.
The results will be shared in an oral presentation at the EORTC CLTG1 Annual Meeting, taking place from 22-24 September 2022 in Madrid, Spain, presented by Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris.
As of the March 4, 2022 data cutoff, patients in the KIR3DL2-expressing MF patients (cohort 2) 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), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months.
Results showed that lacutamab produced a global objective response rate (ORR) of 28.6% (95% confidence interval [CI], 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses. Results from the KIR3DL2 non-expressing cohort 3 are also presented.
“We are pleased to see that lacutamab continues to show clinical activity in these heavily-pretreated patients with mycosis fungoides, confirming our hypothesis that lacutamab, a KIR3DL2 targeted agent, could provide benefit to patients with tumors expressing the target,” said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma. “We look forward to sharing 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.”
“Treatment options are limited for patients with advanced stage mycosis fungoides, and cutaneous T-cell lymphomas,” said Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris, and investigator in the TELLOMAK study. “The clinical responses and favorable safety profile observed in the TELLOMAK Phase 2 study, along with the skin responses, make lacutamab a very exciting potential treatment option for the patients. We look forward to the final results of the TELLOMAK study.”
Summary of Stage 1 results2,3:
|
|
Cohort 2 KIR3DL2 expressing MF patients (n=21) |
Cohort 3 KIR3DL2 non-expressing MF patients (n=18) |
|
N prior systemic therapies, median (range) |
4 (2-8) |
4.5 (2-15) |
|
Global ORR [95% CI] |
28.6% [13.8-50.0] |
11.1% [3.1-32.8] |
|
Skin [95% CI] |
57.1% [36.5-75.5] |
16.7% [5.8-39.2] |
|
Blood [95% CI] |
62.5% [30.6-86.3] |
25% [4.6-69.9] |
|
Lymph node [95% CI] |
7.7% [1.4-33.3] |
0% |
|
Median PFS4 [95% CI] |
12.0 mo [4.6-15.4] |
8.5 mo [4.1-NA] |
|
PFS at 12mo [95% CI] |
53.6% [29.4-72.8] |
39.6% [13.6-65.0] |
In line with previous observations, lacutamab demonstrated a favorable safety profile in MF also in the skin. Grade ≥ 3 Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs) were observed in 2/39 (5.1%) pts and 1/39 (2.6%) patients discontinued study drug due to adverse events. Most common TR TEAEs were asthenia (N=5, 12.8%), arthralgia (N=4, 10.3%), and nausea (N=3, 7.7%).
About Lacutamab:
Lacutamab (IPH4102) 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 has 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.
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.
- 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 MF cohorts 2 and 3 follow a Simon 2-stage design that will terminate early if treatment is considered futile. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
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.
Global response in cutaneous lymphoma is measured by the guidelines published by Olsen et. al in the Journal of Clinical Oncology in 20115.
