Preliminary data set presented at EORTC CLTG
annual meeting confirms clinical activity and favorable safety
profile of lacutamab in patients with mycosis fungoides who express
KIR3DL2 and who were previously treated with at least two lines of
systemic therapy
Regulatory News:
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 2011.5
About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage oncology-focused
biotech company dedicated to improving treatment and clinical
outcomes for patients through therapeutic antibodies that harness
the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies includes several
potentially first-in-class clinical and preclinical candidates in
cancers with high unmet medical need.
Innate is a pioneer in the understanding of Natural Killer cell
biology and has expanded its expertise in the tumor
microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
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
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, 2021,
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 EORTC CLTG : European Organisation for Research and Treatment
of Cancer Cutaneous Lymphoma Tumour Group 2 Data cutoff : March 4,
2022 3 The data presented at the EORTC CLTG Meeting has a longer
follow-up with 5 additional patients across both cohorts than data
presented at 16 International Conference on Malignant Lymphoma on
June 2021. 4 PFS : Progression Free Survival 5 Olsen EA, Whittaker
S, Kim YH, et al. Clinical end points and response criteria in
mycosis fungoides and Sézary syndrome: a consensus statement of the
International Society for Cutaneous Lymphomas, the United States
Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task
Force of the European Organisation for Research and Treatment of
Cancer. J Clin Oncol. 2011;29(18):2598-2607.
doi:10.1200/JCO.2010.32.0630
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Investors Innate
Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr Media
Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44
71 00 15 innate@newcap.eu
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