Innate Pharma Presents Lacutamab Improved Health-related Quality of Life Data at ASH 2024 From TELLOMAK Phase 2 Study in Patients With Cutaneous T Cell Lymphoma
Innate Pharma presented new data from the TELLOMAK Phase 2 study showing quality-of-life improvements in patients with cutaneous T-cell lymphoma (CTCL) treated with lacutamab. The study included 163 patients: 56 with Sézary syndrome (SS) and 107 with mycosis fungoides (MF).
Key findings for SS patients showed reduction in itch intensity from Week 5, reaching mild levels by Week 13. Skin-related symptoms improved significantly, with Skindex-29 scores decreasing from 52.7 at baseline to 14.4 by Week 45.
For MF patients, itch intensity improved from Week 5, with deeper improvement from Week 37. Skindex-29 scores showed early reductions, decreasing from 56.3 to 38.8 by Week 29.
Translational analysis revealed lacutamab's effectiveness in depleting KIR3DL2-expressing circulating tumor cells and skin cells, supporting its potential as a treatment option for SS patients.
Innate Pharma ha presentato nuovi dati dallo studio di Fase 2 TELLOMAK, che mostrano miglioramenti nella qualità della vita nei pazienti affetti da linfoma cutaneo a cellule T (CTCL) trattati con lacutamab. Lo studio ha incluso 163 pazienti: 56 con sindrome di Sézary (SS) e 107 con micosi fungoide (MF).
I risultati chiave per i pazienti con SS hanno mostrato una riduzione dell'intensità del prurito a partire dalla settimana 5, raggiungendo livelli lievi entro la settimana 13. I sintomi legati alla pelle hanno mostrato un miglioramento significativo, con i punteggi Skindex-29 che sono passati da 52.7 al basale a 14.4 entro la settimana 45.
Per i pazienti con MF, l'intensità del prurito è migliorata dalla settimana 5, con un ulteriore miglioramento dalla settimana 37. I punteggi Skindex-29 hanno mostrato riduzioni precoci, scendendo da 56.3 a 38.8 entro la settimana 29.
Un'analisi traslazionale ha rivelato l'efficacia del lacutamab nell'eliminare le cellule tumorali circolanti e le cellule cutanee espresse da KIR3DL2, a sostegno del suo potenziale come opzione terapeutica per i pazienti con SS.
Innate Pharma presentó nuevos datos del estudio de Fase 2 TELLOMAK que muestran mejoras en la calidad de vida de los pacientes con linfoma cutáneo de células T (CTCL) tratados con lacutamab. El estudio incluyó a 163 pacientes: 56 con síndrome de Sézary (SS) y 107 con micosis fungoide (MF).
Los hallazgos clave para los pacientes con SS mostraron una reducción en la intensidad del picor a partir de la semana 5, alcanzando niveles leves para la semana 13. Los síntomas relacionados con la piel mejoraron significativamente, con los puntajes de Skindex-29 disminuyendo de 52.7 en la línea base a 14.4 en la semana 45.
Para los pacientes con MF, la intensidad del picor mejoró desde la semana 5, con una mejora más pronunciada desde la semana 37. Los puntajes de Skindex-29 mostraron reducciones tempranas, disminuyendo de 56.3 a 38.8 para la semana 29.
El análisis traslacional reveló la efectividad del lacutamab en la eliminación de células tumorales circulantes que expresan KIR3DL2 y células cutáneas, respaldando su potencial como opción de tratamiento para pacientes con SS.
Innate Pharma는 lacutamab으로 치료받은 피부 T세포 림프종(CTCL) 환자의 삶의 질 개선을 보여주는 TELLOMAK 2상 연구의 새로운 데이터를 발표했습니다. 이 연구에는 163명의 환자가 포함되었으며, 56명은 세자리 증후군(SS), 107명은 진균성 피부염(MF) 환자입니다.
SS 환자에 대한 주요 발견은 5주차부터 가려움증 강도가 감소하기 시작해 13주차에는 경미한 수준에 도달했다는 것입니다. 피부 관련 증상은 크게 개선되었고, Skindex-29 점수는 기준선에서 52.7에서 45주차에 14.4로 감소했습니다.
MF 환자는 5주차부터 가려움증 강도가 개선되었으며, 37주차부터 더 깊은 개선이 나타났습니다. Skindex-29 점수는 조기 감소를 보여주며, 29주차에 56.3에서 38.8로 감소했습니다.
전이 분석에서는 lacutamab이 KIR3DL2를 발현하는 순환 종양 세포와 피부 세포를 제거하는 데 효과적임을 보여주어 SS 환자에 대한 치료 옵션으로서의 가능성을 뒷받침했습니다.
Innate Pharma a présenté de nouvelles données de l'étude TELLOMAK de phase 2 montrant des améliorations de la qualité de vie chez les patients atteints de lymphome cutané à cellules T (CTCL) traités par lacutamab. L'étude a inclus 163 patients : 56 avec le syndrome de Sézary (SS) et 107 avec la mycose fongoïde (MF).
Les résultats clés pour les patients SS ont montré une réduction de l'intensité des démangeaisons à partir de la semaine 5, atteignant des niveaux légers à la semaine 13. Les symptômes cutanés se sont significativement améliorés, avec des scores Skindex-29 qui ont diminué de 52,7 à la ligne de base à 14,4 à la semaine 45.
Pour les patients MF, l'intensité des démangeaisons s'est améliorée à partir de la semaine 5, avec une amélioration plus profonde à partir de la semaine 37. Les scores Skindex-29 ont montré des réductions précoces, passant de 56,3 à 38,8 à la semaine 29.
L'analyse translationnelle a révélé l'efficacité du lacutamab à épuiser les cellules tumorales circulantes et les cellules cutanées exprimant KIR3DL2, soutenant son potentiel en tant qu'option de traitement pour les patients SS.
Innate Pharma hat neue Daten aus der TELLOMAK-Phase-2-Studie präsentiert, die Verbesserungen der Lebensqualität bei Patienten mit kutanem T-Zell-Lymphom (CTCL) zeigen, die mit lacutamab behandelt wurden. Die Studie umfasste 163 Patienten: 56 mit Sézary-Syndrom (SS) und 107 mit Mycosis fungoides (MF).
Die wichtigsten Ergebnisse für SS-Patienten zeigten eine Reduzierung der Juckreizintensität ab Woche 5, die bis Woche 13 auf milde Werte erreicht wurde. Hautbezogene Symptome verbesserten sich signifikant, wobei die Skindex-29-Werte von 52,7 zu Beginn auf 14,4 in Woche 45 fielen.
Bei MF-Patienten verbesserte sich die Juckreizintensität ab Woche 5, mit einer tiefergehenden Verbesserung ab Woche 37. Die Skindex-29-Werte zeigten frühzeitige Reduzierungen, die von 56,3 auf 38,8 in Woche 29 sanken.
Die translationalen Analysen zeigten die Wirksamkeit von lacutamab bei der Depletion von zirkulierenden Tumorzellen und Hautzellen, die KIR3DL2 exprimieren, was sein Potenzial als Behandlungsoption für SS-Patienten unterstützt.
- Clinical improvement in quality of life metrics for both SS and MF patients
- Sustained reduction in itch intensity from Week 5 onwards
- Significant decrease in Skindex-29 scores indicating improved skin-related symptoms
- Demonstrated effectiveness in depleting tumor cells regardless of baseline burden
- Patients required multiple prior therapies (median of 5 for SS and 4 for MF)
- Advanced disease state in majority of SS patients (67.9% with extensive skin involvement)
Insights
The TELLOMAK Phase 2 study results demonstrate significant clinical benefits for both Sézary Syndrome (SS) and Mycosis Fungoides (MF) patients treated with lacutamab. The data shows meaningful improvements in two critical areas: itch intensity reduction and skin-related symptoms.
For SS patients, the rapid improvement in itch intensity (reaching VAS<4 by Week 13) and sustained reduction in Skindex-29 scores (from 52.7 to 14.4 by Week 45) represent clinically meaningful outcomes. The translational analysis revealing early depletion of KIR3DL2-expressing cells provides mechanistic validation of lacutamab's efficacy.
MF patients also showed progressive improvement, though at a more gradual pace, with itch reduction becoming more pronounced after Week 37. The study's robust patient enrollment (163 total) and heavily pretreated population strengthen the reliability of these findings.
These quality-of-life data significantly enhance lacutamab's commercial potential in the CTCL market. The demonstrated efficacy in heavily pretreated patients (median 4-5 prior therapies) positions lacutamab as a valuable late-line treatment option in a market with alternatives.
The dual benefit in both SS and MF expands the potential patient population, though the more rapid response in SS patients might influence initial market positioning. The mechanistic insights from translational studies, particularly the correlation between KIR3DL2 expression and response, could support development of companion diagnostics and targeted patient selection.
For Innate Pharma, these positive results could strengthen partnership opportunities and support pricing discussions, particularly given the high unmet need in advanced CTCL.
- Findings reveal promising early signs that lacutamab may help alleviate some of the most distressing symptoms of cutaneous T cell lymphomas
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced new data highlighting the quality-of-life improvements observed in patients with cutaneous T-cell lymphoma (CTCL) treated with lacutamab in the TELLOMAK Phase 2 clinical study. These data were presented at the 66th American Society of Hematology (ASH) Annual Meeting in
The TELLOMAK study addresses a critical unmet need for patients with advanced-stage CTCL, particularly Sézary syndrome (SS) and mycosis fungoides (MF), who often experience debilitating symptoms such as severe itching and recurrent skin infections that profoundly impact their physical and social well-being.
Patients with relapsed or refractory CTCL face limited treatment options and often report lower health-related quality of life, particularly those in advanced stages. TELLOMAK’s findings reveal promising signs that lacutamab may help alleviate some of the most distressing symptoms of this disease early on treatment. The TELLOMAK trial enrolled 163 patients with advanced CTCL, including 56 with SS and 107 with MF. The study’s quality of life measures included the Visual Analogue Scale (VAS) for itch intensity and the Skindex-29 score, a validated tool for assessing the impact of skin conditions on patient quality of life.
“These findings underscore the potential of lacutamab for patients with advanced CTCL, particularly Sézary syndrome and mycosis fungoides, who face severe symptoms and limited treatment options. The promising results, including sustained itch reduction and improved skin symptoms, offer hope for enhancing quality of life. We are excited about lacutamab’s potential to bring meaningful relief to patients enduring this challenging disease,” commented Dr Pierluigi Porcu, Director, Division of Medical Oncology and Hematopoietic Stem Cell Transplantation Thomas Jefferson University, and principal investigator in the TELLOMAK study.
“We are encouraged by the data showing that lacutamab may help alleviate some of the most distressing symptoms of cutaneous T cell lymphomas. We remain committed to bringing lacutamab to patients in need and we remain focused on exploring all pathways forward to ensure this potential treatment reaches those who could benefit from it. Our dedication to addressing the unmet needs of patients continues to drive our efforts,” added Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.
Health-related quality of life findings from the TELLOMAK Phase 2 study
Sézary Syndrome Patients (n=56)
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Patient Profile: Median age of 69, advanced disease (
67.9% with erythema covering over80% body surface area), and a median of five prior systemic therapies, high score of pruritus (VAS 6.2) and severe Skindex-29 score (52.7) at baseline. - Improvement in Itch intensity: From Week 5, patients experienced a reduction in itch intensity, with a clinically significant 2-point decrease on the VAS scale to mild by Week 13 (VAS<4), which was sustained over time.
- Reduction in Skin-Related Symptoms: Patients reported notable improvements on the Skindex-29 scale, beginning as early as Week 5 (Skindex 38.7). Scores continued to decrease to mild then low score (Skindex 27.8 by Week 13 and Skindex 14.4 by Week 45), indicating sustained improvements in skin-related symptoms over time.
Mycosis Fungoides Patients (n=107)
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Patient Profile: Median age of 62, less advanced disease (
15.9% T4 stage), and a median of four prior systemic therapies, high score of pruritus (VAS 6) and severe Skindex-29 score (56.3) at baseline. - Improvement in Itch intensity: from Week 5 (VAS 5), with a deeper improvement observed from Week 37 (<4) onward.
- Reduction in Skin-Related Symptoms: Skindex-29 scores also showed early reductions from Week 5 with less severe score (Skindex 46.3), with more pronounced decreases to moderate score by Week 29 (Skindex 38.8) then low score, reflecting gradual yet meaningful improvement in symptoms affecting daily life.
Translational analysis of the TELLOMAK Phase 2 study.
In addition, data on the translational analysis from the study in patients with R/R Sézary Syndrome were presented at the 66th ASH Annual Meeting.
The results show lacutamab induced early and deep depletion of KIR3DL2-expressing circulating tumor cells (CTCs) irrespective of the baseline blood tumor burden. Blood response correlated with the percentage of KIR3DL2 expression on CTCs. In addition, lacutamab induced depletion of skin KIR3DL2+ CD4+ cells regardless of their density and percentage among CD4+ T cells, which occur prior to the median time to skin response. The patients responding to lacutamab in skin have higher baseline CD68+ CD16+ macrophage density suggesting antibody-dependent cell phagocytosis is a mechanism of action of lacutamab in skin.
These data confirm at a translational level the activity of lacutamab, and its potential as a compelling future treatment option for SS patients with high unmet medical need.
The presentation and poster will be available in the publication section of Innate Pharma’s website.
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 three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC).
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, several ANKET® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors.
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.
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