Innate Pharma Presents Positive Results From TELLOMAK Phase 2 Study With Lacutamab in Mycosis Fungoides
- In heavily pretreated patients with mycosis fungoides, treatment with lacutamab results in meaningful anti-tumor activity regardless of baseline KIR3DL2 expression level. Lacutamab was well-tolerated with a safety profile consistent with prior studies.
-
Innate will host a virtual KOL event on
Tuesday, June 11, 2024 at4:00PM CEST (10:00AM EDT ).
As of
The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate (ORR) was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses (CR) and 16 partial responses (PR). In patients expressing a baseline KIR3DL2 ≥ 1%, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group. Time to response was 1.0 month (95% CI 1, 5).
“The anti-tumor activity observed in the Phase 2 TELLOMAK trial confirms that treatment with lacutamab achieves clinically meaningful outcomes for heavily pretreated patients with mycosis fungoides regardless of baseline KIR3DL2 expression level,” commented Dr.
Prof.
Efficacy in MF patients and according to KIR3DL2 subgroup
ITT set |
All MF
|
KIR3DL2 ≥ 1%
|
KIR3DL2 <1%
|
Olsen 2011 Global ORR % (95%CI) |
16.8% (10.9, 25.0) |
20.8% (11.7, 34.3) |
13.6% (7.0, 24.5) |
Olsen 2022 Global ORR % (95%CI) |
22.4% (15.6, 31.2) |
29.2% (18.2, 43.2) |
16.9% (9.5, 28.5) |
CR n (%) |
2 (1.9) |
2 (4.2) |
0 (0.0) |
PR n (%) |
16 (15.0) |
8 (16.7) |
8 (13.6) |
SD1 n (%) |
74 (69.2) |
30 (62.5) |
44 (74.6) |
PD n (%) |
13 (12.1) |
6 (12.5) |
7 (11.9) |
NE n (%) |
2 (1.9) |
2 (4.2) |
0 (0.0) |
Time to global response (mo) median (range) |
1.0 (1-5) |
1.0 (1-5) |
1.9 (1-4) |
Skin response (n=107) % (95%CI) |
29.0% (21.2;38.2) |
33.3% (21.7;47.5) |
25.4% (16.1;37.8) |
PFS (months) median (95%CI) |
10.2 (6.5, 16.8) |
12.0 (5.6, 20.0) |
8.5 (6.5, 17.5) |
Virtual KOL Event Details
The live webcast will be available at the following link:
https://events.q4inc.com/attendee/476217548
Participants may also join via telephone using the following registration link:
https://registrations.events/direct/Q4I23670789
This information can also be found on the Investors section of the
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
About TELLOMAK
TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in
- 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.
The trial is fully enrolled. 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.
About
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types.
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ISIN code
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FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 |
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1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO.
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Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
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Arthur Rouillé
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