Innate Pharma Presents Positive Results From TELLOMAK Phase 2 Study With Lacutamab in Mycosis Fungoides
Innate Pharma has announced positive results from its Phase 2 TELLOMAK study, evaluating lacutamab in patients with mycosis fungoides (MF), a type of cutaneous T cell lymphoma. The study, presented at ASCO 2024, included 107 heavily pretreated patients. Lacutamab demonstrated significant anti-tumor activity, with an objective response rate (ORR) of 22.4% per Olsen 2022 criteria and 16.8% per Olsen 2011 criteria. The median progression-free survival was 10.2 months, and the treatment was well-tolerated. These results support further development of lacutamab for MF patients, regardless of KIR3DL2 expression levels.
- Lacutamab showed significant anti-tumor activity in heavily pretreated MF patients, with an ORR of 22.4% (Olsen 2022).
- The median progression-free survival for all MF patients was 10.2 months.
- Lacutamab was well-tolerated with a safety profile consistent with prior studies.
- In the KIR3DL2 ≥ 1% group, the ORR was higher at 29.2% (Olsen 2022).
- Lacutamab showed a quick time to response, with a median of 1.0 month.
- The ORR for the Olsen 2011 criteria was lower at 16.8%.
- A significant portion of patients (69.2%) experienced stable disease.
- Disease progression was observed in 12.1% of patients.
Insights
The Phase 2 TELLOMAK study results for lacutamab in patients with mycosis fungoides (MF) indicate a significant breakthrough in the treatment of this difficult-to-treat condition. Most notably, the overall response rate (ORR) of
For retail investors, understanding these terms is crucial. ORR refers to the proportion of patients whose cancer shrinks or disappears after treatment. PFS is the length of time during and after treatment that a patient lives with the disease without it getting worse. The trial’s median follow-up of 11.8 months and the CR and partial response (PR) rates speak to the drug's potential in providing new treatment options for MF patients.
These positive Phase 2 trial results for lacutamab could have significant financial implications for Innate Pharma. The data supports further development and potential regulatory approval, which could open lucrative markets for the company. If lacutamab progresses to Phase 3 trials successfully and receives FDA approval, it could become a key revenue driver. This is particularly important given the limited effective treatments for mycosis fungoides, positioning lacutamab in a niche yet potentially profitable market.
Investors should consider the potential for increased research and development (R&D) costs as the drug progresses through clinical trials. However, the long-term revenue prospects from a successful treatment could outweigh these costs. Furthermore, successful trial results might attract partnerships or buyout interests from larger pharmaceutical companies, adding to the stock’s upside potential.
From a clinical perspective, the Phase 2 TELLOMAK study results are encouraging for patients with mycosis fungoides (MF), a rare and often challenging type of cutaneous T-cell lymphoma. The study’s anti-tumor activity in heavily pretreated patients, regardless of KIR3DL2 expression, indicates lacutamab’s broad applicability. This drug could provide a viable option beyond the current standard treatments, which are often limited in efficacy and have considerable side effects.
It’s important to note the favorable safety profile observed, consistent with previous studies. Long-term tolerability and patient quality of life are critical in oncology, especially for a chronic condition like MF. If future studies can confirm these findings, lacutamab could become a cornerstone therapy for MF, potentially improving patient outcomes significantly.
- 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 at 4:00PM CEST (10:00AM EDT).
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF). The results were presented at the ASCO 2024 Annual Meeting, in
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
“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,
Efficacy in MF patients and according to KIR3DL2 subgroup
ITT set |
All MF
|
KIR3DL2 ≥ |
KIR3DL2 < |
Olsen 2011 Global ORR % ( |
(10.9, 25.0) |
(11.7, 34.3) |
(7.0, 24.5) |
Olsen 2022 Global ORR % ( |
(15.6, 31.2) |
(18.2, 43.2) |
(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)
% ( |
(21.2;38.2) |
(21.7;47.5) |
(16.1;37.8) |
PFS (months) median ( |
10.2 (6.5, 16.8) |
12.0 (5.6, 20.0) |
8.5 (6.5, 17.5) |
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:
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 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.
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
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
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 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
Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.
Information about Innate Pharma shares
ISIN code
|
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
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1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO.
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For additional information, please contact:
Investors
Innate Pharma
Henry Wheeler
Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
Media Relations
NewCap
Arthur Rouillé
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innate@newcap.eu
Source: Innate Pharma SA
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