- Oral presentation on the dose-escalation part of a Phase I trial at the International Conference on Malignant Lymphoma (ICML) in Lugano;
- IPH4102 was evaluated in elderly and heavily pretreated patients with advanced cutaneous T-cell lymphomas (CTCL), mostly with Sézary syndrome, a subtype with high unmet medical need;
- IPH4102 was well tolerated: no dose-limiting toxicity was reported and the maximum tolerated dose (MTD) was not reached;
- In patients with Sézary syndrome, best global response rate (ORR) was 47% and disease control rate (DCR) was 90%; this population achieved a median progression free survival (PFS) of 10.8 months.
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announces results from the dose-escalation part of the ongoing Phase I study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL), an orphan disease. IPH4102 is Innate Pharma’s wholly-owned, first-in-class anti-KIR3DL2 humanized therapeutic antibody, designed to trigger immune cell-mediated killing of CTCL cancer cells.
25 patients, with a median age of 71 years old and a median number of four prior systemic treatments, were evaluable for safety (10 dose levels: 0.0001 to 10 mg/kg). The data from the trial indicate that IPH4102 was well tolerated with no dose-limiting toxicity. The maximum tolerated dose (MTD) was not reached. The majority of adverse events reported was typical for CTCL or reflected low grade infusion-related reactions.
As of May 10, 2017, 24 patients were evaluable for clinical activity. In this population, best global overall response rate (ORR) was 41.7% and disease control rate (DCR) was 91.7% across all dose levels. Best global ORR and DCR reached 47.4% and 89.5% respectively in patients with Sézary syndrome (SS, n=19). Among the 9 patients with SS who achieved clinical responses, one had a global complete response**. 5 complete responses were seen in blood and 2 in skin (resp. 26% and 11%). Median duration of response (DOR) was 8.2 months in all patients and not reached in patients with SS. Median progression free survival (PFS) was 9.0 months in all patients and 10.8 months in patients with SS (range from 0.9 to 17.2). Pruritus was significantly decreased in patients with clinical response.
Pharmacodynamic endpoints and molecular residual disease results are consistent with clinical activity results and show substantial elimination of neoplastic cells in skin and in blood.
Pierre Dodion, Chief Medical Officer of Innate Pharma, commented: “The data reported suggest that IPH4102 is very well tolerated in patients with advanced CTCL and shows promising signs of clinical activity. We are thrilled by these results, given that the trial included patients who had received all available treatment options. They give us confidence for the next steps of the development plan of IPH4102; the cohort expansion part of the trial is planned to start in Q3 2017 at the recommended Phase II dose. We are committed to bringing this potential new therapeutic option to patients and will be focused on working closely with the regulatory authorities during the coming months toward this goal.”
Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, added: “We are very pleased with the results of the dose-escalation part of the trial. The profile of IPH4102 is very promising. Today, there is no satisfactory treatment and IPH4102 could be a new therapeutic option for CTCL patients in high medical need at advanced stages of the disease.”
These data were presented in an oral presentation at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 14. The presentation is available on the Company’s website, in the Product Pipeline - IPH4102 section.
On June 15, 2017, the management team held a conference call for institutional investors and sell-side analysts on
the acquisition of the anti-C5aR antibody as well as IPH4102 data.
* In CTCL, global clinical response assessment is a composite of response evaluation in all organs involved with tumor cells, such as skin, blood, lymph nodes and viscera (E. Olsen et al, JCO 2011).
|PR in English||99.84 KB|
|CP en français||101.4 KB|
|ICML 2017: Dose-escalation safety, biomarker and clinical activity results (Phase I in relapsed/refractory CTCL)||813.6 KB|
|Conference call presentation||1.39 MB|