New clinical developments for France-based Innate Pharma’s first-in-class, proprietary investigational asset, lacutamab, includes the advancement of the KIR3DL2-expressing mycosis fungoides (MF) cohort (cohort 2) to Stage 2 in the TELLOMAK study, as well as the initiation of the peripheral T-cell lymphoma (PTCL) clinical program.[1][2]
Mycosis fungoides, also known as Alibert-Bazin syndrome or granuloma fungoides, is the most common form of cutaneous T-cell lymphoma. It generally affects the skin, but may progress internally over time. Symptoms include rash, tumors, skin lesions, and itchy skin.
Lacutamab is an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas. In TELLOMAK study, an open-label, multi-cohort, Phase II trial, lacutamab demonstrated a positive early signal in cohort 2. This cohort reached the pre-determined number of responses needed to advance to stage 2, allowing Innate Pharma to recruit additional patients. Preliminary data will be presented at a scientific meeting later 2021.
Recruitment is ongoing in cohort 3, evaluating lacutamab as a monotherapy in KIR3DL2 non-expressing mycosis fungoides patients.
A Data-Driven Clinical Strategy
As part of the development program, two two parallel clinical trials will be initiated to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory PTCL. Together these trails are expected to offer a data-driven strategy to identify potential opportunities for lacutamab in the relapsed setting, and potential expansion into earlier lines of therapy for PTCL in the future.
- Phase Ib trial: a Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.
- Phase II KILT (anti-KIR in T Cell Lymphoma) trial: A randomized investtor-sponsored study by The Lymphoma Study Association (LYSA) designed to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
“Lacutamab is our priority clinical asset, and we are pleased to share important progress of this program. The early signal seen in the KIR3DL2-expressing mycosis fungoides patient population is encouraging and moves us past the pre-determined threshold for the cohort earlier than anticipated,” explained Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma.
“In addition, our PTCL trials announced today demonstrate our strategy to first explore lacutamab’s potential in the relapsed/refractory setting, then potentially in earlier lines of treatment. Partnering with LYSA will provide invaluable expertise given their track record in advancing therapeutics for the lymphoma community.”
“Relapsed PTCL patients are in need of alternative, effective options and we are pleased to partner with Innate Pharma on this important study,” noted Franck Morschhauser, Professor of Hematology in Lille (France) and President of LYSA.
“KIR3DL2 represents a meaningful target, as it is expressed in up to 50% of PTCL across subtypes. Through our global network and deep expertise in lymphoma, we believe this study will help us better understand the potential for lacutamab to help these patients,” Morschhauser concluded.
Clinical trials
PH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK) – NCT03902184
Research
[1] Quaglino P. Anti-KIR3DL2 therapy in the treatment of Sézary syndrome. Lancet Oncol. 2019 Aug;20(8):1048-1049. doi: 10.1016/S1470-2045(19)30393-6. Epub 2019 Jun 25. PMID: 31253571.
[2] Bagot M, Porcu P, Marie-Cardine A, Battistella M, William BM, Vermeer M, Whittaker S, Rotolo F, Ram-Wolff C, Khodadoust MS, Bensussan A, Paturel C, Bonnafous C, Sicard H, Azim HA Jr, Kim YH. IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial. Lancet Oncol. 2019 Aug;20(8):1160-1170. doi: 10.1016/S1470-2045(19)30320-1. Epub 2019 Jun 25. PMID: 31253572.
