-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

1631 Lacutamab in Patients with Advanced Sezary Syndrome: Results from an Interim Analysis of the Tellomak Phase 2 Trial

Program: Oral and Poster Abstracts
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Hematology Disease Topics & Pathways:
Lymphomas, T Cell lymphoma, Diseases, Lymphoid Malignancies
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Martine Bagot1*, Youn H. Kim, MD2, Pablo L. Ortiz-Romero3*, Pier Luigi Zinzani, MD, PhD4, Neha Mehta-Shah, MD, MSCI5, Olivier Dereure6*, Marie Beylot-Barry7*, Stéphane Dalle8*, Eric D Jacobsen9, Auris Huen, MD, PharmD10*, Andrea Combalia11*, Maxime Battistella, MD, PhD12*, Alejandro A. Gru, MD13*, Hélène Moins-Teisserenc, MD, PhD14*, Michael S. Khodadoust, MD PhD15, Julien Viotti16*, Christine Paiva16*, Marianna Muller16* and Pierluigi Porcu, MD17

1Department of Dermatology, Hôpital Saint Louis, Université Paris Cité, Inserm U976, Paris, CT, France
2Stanford Cancer Institute, Stanford, CA
3Department of Dermatology, Hospital 12 de Octubre Medical School, University Complutense, Madrid, Spain
4Institute of Hematology “Seràgnoli”, University of Bologna, Bologna, Italy
5Division of Oncology, Washington University School of Medicine, St. Louis, MO
6Department of Dermatology, CHU Montpellier, Université Montpellier I, Montpellier, France
7Department of Dermatology, Centre Hospitalier Universitaire de Bordeaux – Hôpital Saint-André, B, Bordeaux, France
8Department of Dermatology, Hospices Civils de Lyon, Pierre Bénite, Lyon, France
9Dana-Farber Cancer Institute, Boston, MA
10Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX
11Department of Dermatology, Hospital Clinic de Barcelona, Barcelona, Spain
12INSERM U1165, Universite Paris 7, AP-HP Hopital Saint Louis, Paris, FRA
13Department of Pathology, University of Virginia, Charlottesville, VA
14Hematology Laboratory, Hopital Saint-Louis, AP-HP, Université Paris Cité, INSERM U976, Paris, France
15Department of Medicine, Divisions of Oncology and Hematology, Stanford University, Stanford, CA
16INNATE PHARMA, Marseille, France
17Sidney Kimmel Cancer Center at Jefferson Health, Thomas Jefferson University, Philadelphia, PA

Introduction:

Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin lymphoma. Sezary syndrome (SS) is a rare and aggressive type of CTCL. It has a unique biology, with high expression of KIR3DL2 reported in more than 85% of patients (pts). SS is characterized by erythroderma, significant blood involvement with malignant SS cells, and lymphadenopathy. These pts suffer from debilitating itching and recurrent skin infections, often affecting quality of life (QoL). SS is distinguished by its poor prognosis, as the median survival of pts is approximately 5 years. To date vorinostat, is the only drug that has been approved by the FDA for the treatment of pts with CTCL with cutaneous manifestations who have received 2 prior systemic therapies.

Methods

TELLOMAK is an international, open-label, phase 2 trial with multiple cohorts (NCT03902184). Cohort 1, for which preliminary data is reported here, is designed to evaluate safety and efficacy of single agent lacutamab in pts with relapsed/refractory SS after at least 2 prior systemic therapies including mogamulizumab. Pts should have blood stage B2 at screening based on central evaluation by flow cytometry. Pts with evidence of large cell transformation are excluded. lacutamab 750 mg is administered as an intravenous infusion weekly × 5 weeks (w), every 2 w × 10, then every 4 w until progression or unacceptable toxicity. Primary endpoint is Objective Response Rate (ORR) by global response score. Secondary endpoints include additional efficacy endpoints, safety, QoL and translational assessments.

Results

At the data cut-off of April 29, 2022, 38 pts were enrolled and 37 pts treated with a median follow-up of 10.9 months (m) (range: <1, 34 m). Median age was 69 years (range: 50, 86). At study entry, the median prior lines of systemic therapies was 6 (range: 2, 11), 94.6% (n=35) had stage IVA and 5.4% (n=2) had stage IVB.

In the ITT population, Global Confirmed ORR was 21.6% (8/37; 95% CI 11.4, 37.2). Confirmed ORR in skin was 35.1% (13/37; 95% CI 21.8, 51.2). Confirmed ORR in blood was 37.8% (14/37; 95% CI 24.1, 53.9), with 21.6% (8/37) CR as best overall response. Furthermore, 1 of the 28 pts with lymph node involvement at baseline achieved a CR. Grade ≥ 3 Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs) were observed in 6/37 (16.2%) pts, Serious TR TEAEs were observed in 2/37 (5.4%) and 4/37 (10.8%) pts discontinued study drug due to TEAE. Data from additional key endpoints will be presented.

Conclusion

In this highly refractory SS cohort from the TELLOMAK study, our preliminary data demonstrate that lacutamab shows clinical activity and favourable safety profile. Continued evaluation of this new targeted treatment option for patients with SS is warranted.

Disclosures: Bagot: INNATE PHARMA: Membership on an entity's Board of Directors or advisory committees, Research Funding. Kim: Elorac: Research Funding; INNATE PHARMA: Membership on an entity's Board of Directors or advisory committees, Research Funding; Galderma: Honoraria, Research Funding; CRISPR Therapeutics: Research Funding; Soligenix: Research Funding; Kyowa Kirin: Honoraria, Research Funding; Eisai: Research Funding; Portola/Alexion Pharma: Research Funding; Corvus: Membership on an entity's Board of Directors or advisory committees, Research Funding; Trillium: Research Funding; Secura Bio: Honoraria; Mundipharma: Honoraria; Regeneron: Honoraria; Sanofi: Honoraria. Ortiz-Romero: Miragen: Membership on an entity's Board of Directors or advisory committees; Kyowa: Membership on an entity's Board of Directors or advisory committees; Innate Pharma: Membership on an entity's Board of Directors or advisory committees; 4SC: Membership on an entity's Board of Directors or advisory committees; Actelion: Membership on an entity's Board of Directors or advisory committees; Helsinn: Membership on an entity's Board of Directors or advisory committees; Recordati Rare Diseases: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Zinzani: Beigene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sandoz: Membership on an entity's Board of Directors or advisory committees; MSD: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Eusapharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kyowa Kirin: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Celltrion: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Secura Bio: Membership on an entity's Board of Directors or advisory committees; University of Bologna: Current Employment. Mehta-Shah: Corvus Pharmaceuticals: Research Funding; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees, Research Funding; Genetech/Roch: Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Kyowa Hakko Kirin Co., Ltd.: Membership on an entity's Board of Directors or advisory committees; Secura Bio: Membership on an entity's Board of Directors or advisory committees, Research Funding; Verastem: Research Funding; Celgene: Research Funding; Bristol Myers-Squibb: Research Funding; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees. Beylot-Barry: Kyowa: Consultancy. Jacobsen: Hoffmann-LaRoche: Research Funding; Eisai: Consultancy; Innate Pharma: Consultancy; Bayer: Consultancy; Imbrium: Consultancy; Daiichi: Consultancy; Merck: Consultancy; Bristol Myers: Honoraria; Pharmacyclics: Research Funding; Merck: Research Funding; Celgene: Research Funding; Secura: Consultancy. Huen: kyowa: Consultancy. Battistella: Innate Pharma: Consultancy; Kyowa Kirin: Consultancy, Research Funding, Speakers Bureau; Takeda: Consultancy, Research Funding, Speakers Bureau; Bristol Myers Squibb: Consultancy; Sanofi: Consultancy; Recordati: Other: traveling fees. Gru: Innate Pharma: Consultancy; StemLine Therapeutics: Consultancy; Kyowa Kyrin: Consultancy; CRISPR Therapeutics: Other: Co-investigator ; Seattle Genetics: Consultancy. Moins-Teisserenc: Innate Pharma: Consultancy; Kyowa Kirin: Other: Congress fees . Khodadoust: Nutcracker Therapeutics: Research Funding; Myeloid Therapeutics: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; CRISPR Therapeutics: Research Funding. Viotti: INNATE PHARMA: Current Employment. Paiva: INNATE PHARMA: Current Employment. Muller: Servier: Ended employment in the past 24 months; INNATE PHARMA: Current Employment. Porcu: Ono: Membership on an entity's Board of Directors or advisory committees; Teva: Honoraria, Research Funding; Daiichi, Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees; Innate Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Viracta: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BeiGene: Membership on an entity's Board of Directors or advisory committees; Morphosys: Membership on an entity's Board of Directors or advisory committees; DrenBio: Consultancy; ADCT: Membership on an entity's Board of Directors or advisory committees; Loxo: Membership on an entity's Board of Directors or advisory committees.

*signifies non-member of ASH