- Efficacy results, analyzed according to updated lymph node
involvement classification, confirm clinical activity and favorable
safety profile of lacutamab in advanced Mycosis Fungoides
- Updated global ORR of 42.9% in heavily pretreated
KIR3DL2-expressing patients with Mycosis Fungoides
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced 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. The data confirms clinical activity and
favorable safety profile of lacutamab, an anti-KIR3DL2
antibody.
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.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology
company developing immunotherapies for cancer patients. Its
innovative approach aims to harness the innate immune system
through therapeutic antibodies and its ANKET®
(Antibody-based NK cell Engager
Therapeutics) proprietary platform.
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.
Innate Pharma is a trusted partner to biopharmaceutical
companies such as Sanofi and AstraZeneca, as well as leading
research institutions, to accelerate innovation, research and
development for the benefit of patients.
Headquartered in Marseille, France with a US office in
Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq
in the US.
Learn more about Innate Pharma at www.innate-pharma.com and
follow us on Twitter and LinkedIn.
Information about Innate Pharma shares
ISIN code Ticker
code LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
9695002Y8420ZB8HJE29
Disclaimer on forward-looking information and risk
factors
This press release contains certain forward-looking statements,
including those within the meaning of the Private Securities
Litigation Reform Act of 1995. The use of certain words, including
“believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify forward-looking statements.
Although the company believes its expectations are based on
reasonable assumptions, these forward-looking statements are
subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. These
risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including
related to safety, progression of and results from its ongoing and
planned clinical trials and preclinical studies, review and
approvals by regulatory authorities of its product candidates, the
Company’s commercialization efforts and the Company’s continued
ability to raise capital to fund its development. For an additional
discussion of risks and uncertainties which could cause the
company's actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque")
section of the Universal Registration Document filed with the
French Financial Markets Authority (“AMF”), which is available on
the AMF website http://www.amf-france.org or on Innate Pharma’s
website, and public filings and reports filed with the U.S.
Securities and Exchange Commission (“SEC”), including the Company’s
Annual Report on Form 20-F for the year ended December 31, 2022,
and subsequent filings and reports filed with the AMF or SEC, or
otherwise made public, by the Company.
This press release and the information contained herein do not
constitute an offer to sell or a solicitation of an offer to buy or
subscribe to shares in Innate Pharma in any country.
___________________________
1 Olsen et al. Blood 2022, 140
(5):419-437. Primary cutaneous lymphoma: recommendations for
clinical trial design and staging update from the ISCL, USCLC, and
EORTC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230921031989/en/
Investors Innate
Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
NewCap Arthur Rouillé Tel. :
+33 (0)1 44 71 00 15 innate@newcap.eu
Innate Pharma (NASDAQ:IPHA)
Historical Stock Chart
From Sep 2024 to Oct 2024
Innate Pharma (NASDAQ:IPHA)
Historical Stock Chart
From Oct 2023 to Oct 2024