On June 4, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF) (Press release, Innate Pharma, JUN 4, 2024, View Source [SID1234644092]). The results were presented at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting, in Chicago, Illinois.

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As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months.

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. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "These results are very promising, considering the number of prior systemic therapies that the patients had received before, and the lack of available drugs. These data support further development of lacutamab to bring improved treatments to patients with cutaneous T cell lymphomas."

Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, and Principal Investigator in the TELLOMAK study, added: "Mycosis fungoides patients have few efficacious and safe therapeutic options at advanced stages. It is promising to see lacutamab achieving remarkable efficacy along with excellent tolerability in this heavily pre-treated population. We express our gratitude to the investigators, clinical research coordinators, patients and caregivers involved in the TELLOMAK program."

Efficacy in MF patients and according to KIR3DL2 subgroup
ITT set All MF
N=107
KIR3DL2 ≥ 1%
N=48
KIR3DL2 <1%
N=59
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)
SD n (%)1
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)

1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO.

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)

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Virtual KOL Event Details
Tuesday, June 11, 2024 at 4:00PM CEST (9:00AM EDT)

The live webcast will be available at the following link:
View Source

Participants may also join via telephone using the following registration link: View Source
This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.
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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 (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in 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.

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.