Multicohort, multi-center, international Phase II study to evaluate the efficacy and safety of IPH4102 in patients with advanced T-cell lymphoma is ongoing
Sézary syndrome cohort of the TELLOMAK study is designed to support potential BLA filing
New preclinical data show IPH4102 and chemotherapy combination enhances KIR3DL2 expression and has superior anti-tumor activity, providing rationale for peripheral T-cell lymphoma (PTCL) cohort
Management to host KOL call on Thursday, June 20, 2pm CEST / 8am ET
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced that the design of the “TELLOMAK” Phase II trial and new preclinical data supporting the potential of IPH4102 in peripheral T-cell lymphoma (“PTCL”) as well as Adult T-cell leukemia/lymphoma (“ATLL”) will be presented at the International Conference on Malignant Lymphoma (“ICML”), held from 18 to 22 June 2019 in Lugano, Switzerland.
An oral presentation will take place on Wednesday, June 19, by Pr. Pierluigi Porcu, Director of the Division of Medical Oncology and Hematopoietic Stem Cell Transplantation at Thomas Jefferson University, Philadelphia.
“We are committed to an efficient execution of the TELLOMAK trial, which could potentially support a future BLA submission for IPH4102 in Sézary syndrome”, said Pierre Dodion, Chief Medical Officer of Innate Pharma. “The 2-stage design for the mycosis fungoides (“MF”) and PTCL cohorts stratified by KIR3DL2 expression will allow us to identify patients that are most likely to benefit from treatment. We believe this will optimize the delivery of proof of concept data to inform the design of future potential pivotal trials. We expect to provide an update on the outcome of the first stage of the MF and PTCL cohorts in the second half of 2020 and report initial efficacy data for the different cohorts starting in 2021.”
New preclinical data further support the rationale to evaluate the potential of IPH4102 in larger subsets of T-cell lymphoma. The findings demonstrate that KIR3DL2 is expressed in multiple subtypes of PTCL and that incubation of T-cell lymphoma cell lines with a combination chemotherapy regimen consisting of Gemcitabine and Oxaliplatin (GemOx) enhances KIR3DL2 expression. Moreover, the combination of IPH4102 and GemOx improves anti-tumor activity against a KIR3DL2-positive T-cell line in-vitro.
Another set of preclinical data supports the expansion of the IPH4102 development program in ATLL, which is mostly prevalent in Asia. The data demonstrates that KIR3DL2 expression is mainly associated with the ATLL acute subtype, a subtype that is the most frequent and associated with the poorest prognosis.
Presentation and Posters:
- “TELLOMAK: T-cell lymphoma anti-KIR3DL2 therapy: An open label, multicohort, multi-center, international phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with advanced T-cell lymphoma”,P. Porcu, Philadelphia, PA (USA); article Nr OT06; “Ongoing trials”, Wednesday, June 19, 17:55, Aula Magna (USI Università)
- “KIR3DL2 is expressed in peripheral T-cell lymphomas and may be a therapeutic target”, M. Cheminant, Paris (France); poster Nr. 157, poster discussion June 20-21, 12:30-13:00, Marquee
- “Membrane Expression of NK Receptor KIR3DL2 Contributes to Delineate the Acute-type and is a Therapeutic Target in ATL”, M. Cheminant, Paris (France); poster Nr. 218, poster discussion June 20-21, 12:30-13:00, Marquee
TELLOMAK is a global, open-label, multicohort Phase II clinical trial conducted in the United States and Europe. In this trial, IPH4102 is evaluated alone and in combination with chemotherapy in patients with advanced TCL. TELLOMAK is expected to recruit up to 250 patients, with IPH4102 evaluated:
- As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior treatments, including mogamulizumab,
- As a single agent in approximately 90 patients with MF who have received at least two systemic therapies, and
- In combination with standard chemotherapy (GemOx) in approximately 100 patients with PTCL who have received at least one prior treatment.
In patients with MF and PTCL, the study is designed to evaluate the benefit of IPH4102 according to KIR3DL2 expression: the study will comprise two cohorts for each of the 2 indications, testing IPH4102 in KIR3DL2 expressing and non-expressing patients. These cohorts will follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome arm of the study could enable the registration of IPH4102 in this indication.
The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.