- Differentiating profile of IPH4102 confirmed: high and durable response, favorable safety profile with long-term follow-up and substantial improvement in quality of life
- Innate Pharma expects to initiate a global Phase II study (“TELLOMAK”) in different subtypes of T-cell lymphomas in the first half of 2019
- Management to host KOL call Tuesday, December 4, 5pm CET (8am PST)
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announced updated data from the Phase I trial (including an expansion cohort) evaluating IPH4102 in refractory patients with Sézary syndrome (SS) and its plan to advance IPH4102 in a multi-cohort Phase II study in different subtypes of T-cell lymphoma. An oral presentation will take place on Monday, December 3, at the ASH 2018 Annual Meeting in San Diego, USA, by Pr Martine Bagot, Head of the Dermatology Department at the Saint Louis Hospital, Paris and Principal Investigator of the study. IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, designed for treatment of T-cell lymphoma.
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.
Mogamulizumab pretreated patients (n=7) showed an ORR (42.9%), median DoR (13.8 months) and median PFS (16.8 months) similar to the entire group. The ORR appeared to be higher (n = 28, 53.6%) in patients with no histologic evidence of large cell transformation (LCT*).
“The solid updated data on IPH4102 presented today strongly encourage us to advance IPH4102 in refractory Sézary syndrome patients. We believe that the planned Phase II study, together with the Phase I data, has the potential to support a BLA submission in this indication,” commented Pierre Dodion, Chief Medical Officer of Innate Pharma. “In addition, the expression profile of KIR3DL2 provides a strong rational to explore the potential of IPH4102 in other subtypes of T-cell lymphomas in the TELLOMAK phase II study”.
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.
“Refractory Sézary syndrome patients have limited effective treatment options in later lines of therapy, with toxicity remaining an area of great concern with currently approved drugs,” commented Professor Martine Bagot, Principal Investigator of the study. “IPH4102, in addition to demonstrating an impressive clinical activity, has shown a favorable safety profile and substantially improves the quality of life even in patients with stable disease. Translational results show relevant pharmacodynamics effects of IPH4102 in skin and in blood, which are in line with the clinical efficacy of the drug.”
Exploratory biomarker analysis show early elimination of aberrant tumor cells and peripheral blood KIR3DL2+ CD4 T cells upon IPH4102 administration in responding patients.
The presentation is available in the IPH4102 section on Innate Pharma’s website.
KOL webcast and conference call on Tuesday, December 4, at 5pm CET (8am PST)
Pierre Dodion, Chief Medical Officer, Innate Pharma, and Prof. Martine Bagot, Head of Dermatology Department at the Saint Louis Hospital, Paris and lead investigator of the study, held a live webcast and conference call with a Q&A session on Tuesday, December 4 at 5pm CET to discuss the announcement.
Access to the replay is available at this link: https://edge.media-server.com/m6/p/229ej2mw
* LCT is present in approximatively 10% of Sézary syndrome patients (Talpur, CLML 2016) and is associated with poorer prognosis and shorter survival.