- Fast Track designation (FTD) is intended to expedite the development and regulatory review of IPH4102 for the treatment of adult patients with relapsed or refractory Sézarysyndrome (SS) who have received at least two prior systemic therapies
- FTD is based on the evaluation of Phase I results demonstrating strong clinical activity, favorable safety and substantial improvement in quality of life
- TELLOMAK, a global, multi-cohort, Phase II study evaluating the potential of IPH4102 in different subtypes of T-cell lymphomas, will be initiated in the first half of 2019
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, developed for the treatment of T-cell lymphoma.
Fast Track is a process designed to facilitate the development and expedite the regulatory review of investigational drugs to treat serious conditions and fill an unmet medical need.
“We are pleased that the FDA has granted Fast Track designation to IPH4102 as there remains a high need for treatment options with strong efficacy and adequate safety profile to allow for treatment of Sézarysyndrome, the most aggressive form of cutaneous T-cell lymphoma (CTCL),” said Pierre Dodion, Chief Medical Officer of Innate Pharma. “IPH4102 is a key element of our strategy to build a commercial franchise of treatments focused on rare cancers in the field of hemato-oncology. We intend to initiate a global multi-cohort Phase II study (TELLOMAK) in the first half of 2019 to confirm the clinical activity of IPH4102 in Sézary syndrome and evaluate the potential in other subtypes of T-cell lymphomas, including Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL). We look forward to working with the FDA to advance this promising program through clinical development.”
Sézary syndrome is the leukemic variant of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies.
Fast track designation is based on preliminary results of the Phase I dose-escalation and expansion study of IPH4102 in advanced CTCL (n=44). As of October 15, 2018, data from the subgroup of 35 SS patients revealed strong clinical activity, demonstrated by an overall response rate (ORR) of 42.9%, median duration of response (DoR) of 13.8 months and median progression-free survival (PFS) of 11.7 months. The ORR appeared to be higher (n=28, 53.6%) in patients with no histologic evidence of large cell transformation (LCT)*. Importantly, clinical activity was associated with a substantial improvement in quality of life as assessed by the SkinDex29 and Pruritus Visual Analog Scale (VAS) scores. IPH4102 displayed a favorable safety profile, consistent with previous observations.
*LCT is present in approximatively 10% of Sézary syndrome patients (Talpur, CLML 2016) and is associated with poorer prognosis and shorter survival.