Oral presentation on data with longer follow-up of dose escalation patients and new data from cohort expansion in the Phase I study at the EORTC CLTF 2018 Meeting
IPH4102 showed encouraging clinical activity, demonstrated by high response rate and long progression-free survival (PFS)
Sézary syndrome (SS) subset patients treated in the dose-escalation part (n=20) now show median PFS of close to 1 year
Marseille, France, September 29, 2018, 8:30 AM CEST
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announced new data from the Phase I clinical trial of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL). The data, including longer follow up for patients treated in the dose-escalation and observations from an additional patient cohort, will be presented today at the EORTC Cutaneous Lymphoma Group meeting in St. Gallen, Switzerland, by Pr Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris. IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, designed for treatment of T-cell lymphoma.
“These data support the positive trends observed in the dose-escalation part of the trial and demonstrated a high response rate and long progression-free survival for these heavily pretreated CTCL patients, a majority being Sézary syndrome,” commented Pierre Dodion, Chief Medical Officer of Innate Pharma. “Additionally, these data will serve as a basis for the initiation of a broader Phase II clinical program in Sézary syndrome and other subtypes of T-cell lymphomas. We look forward to providing more insight into the data and subsequent clinical development plans in the near future.”
As of June 28, 2018, a total of 44 patients with relapsed/refractory CTCL were evaluable for safety and clinical activity. The study consisted of two parts: a dose-escalation (n=25) and a cohort expansion (n=19). Patients received a median of 3 prior systemic therapies. IPH4102 demonstrated a favorable safety profile and was well-tolerated. The study showed clinical activity that was demonstrated by a high response rate and long progression free survival.
In the total study population, the objective response rate (ORR) was 36% and median duration of response (DOR) and progression free survival (PFS) were 13.8 and 8.2 months, respectively. Sézary syndrome (SS) subset patients treated in the dose-escalation part (n=20) now show median PFS of close to 1 year. At the cut-off date of June 28, 2018, median follow-up was 12.7 months and nine patients were still ongoing treatment.
Better outcomes were observed in patients without evidence of histologic large cell transformation (LCT) (n=29); these patients achieved an ORR of 51.7% and PFS of 12.8 months. LCT is present in approximatively 10% of all Mycosis fungoides/Sézary syndrome patients* and is associated with poorer prognosis and shorter survival using currently available therapies.
“This patient population remains a high unmet medical need as they continue to progress through several lines of treatments,” commented Pr Martine Bagot, Principal Investigator. “The patients with complete response, partial response and even those with stable disease showed an improvement in quality of life parameters overtime including pruritus. IPH4102’s encouraging clinical activity provides substantial support to explore its potential therapeutic benefits not only in SS patients but also in other T cell lymphoma patient populations. Together with a favorable safety profile, IPH4102 could emerge as a key therapeutic option in aggressive T-cell lymphomas.”
The presentation is available in the IPH4102 section on Innate Pharma’s website.
* Talpur, CLML 2016