Innate Pharma reports phase II clinical data with IPH 1101 in oncology
Innate Pharma reports interim data from the Phase I/II clinical trial evaluating IPH 1101 in combination with rituximab1 in follicular non-Hodgkin’s lymphoma (“fNHL”) patients (study “IPH 1101-202”) and final data for the Phase IIa trial evaluating IPH 1101 in chronic myeloid leukemia (“CML”) patients (study “IPH 1101- 204”).
In the IPH 1101-202 study, IPH 1101 in association with low-dose IL-2 is administered in combination with the standard of care rituximab to fNHL patients relapsing after at least one prior line of rituximab-containing treatment. The primary efficacy endpoint is the overall response rate (complete and partial responses) at six months. Forty-five patients were treated during this trial, recruitment for which is now completed.
From the first 16 evaluable patients assessed by independent central review at six months, 9 patients showed a response (i.e. 56% Overall Response Rate, or “ORR”), including 7 patients showing a complete response (i.e. 44% Complete Response Rate or “CRR”). The response rate observed with standard of care (rituximab alone) in similar settings is about 40% ORR and about 10% CRR2.
The Company expects to report efficacy data at three months for all evaluable patients by the end of 2009. Final data on all evaluable patients are expected by mid-2010.
In the IPH 1101-204 study, IPH 1101 in association with low-dose IL-2 was administered to CML patients showing an incomplete response to the standard of care imatinib. A per protocol analysis of the 14 patients enrolled in the stage 1 of the study did not demonstrate a sufficient effect to move forward the study in a second stage (absence of complete molecular response). Overall, in both studies, the treatment was well tolerated. The most frequent adverse events were cytokine release related, manageable and reversible.
The administration of IPH 1101 plus IL-2 triggered a robust pharmacodynamic effect with the amplification of γδ T cells and the release of immuno-stimulatory and cytotoxic cytokines in both studies. In the fNHL study (IPH 1101-202), the up-regulation of the ADCC-mediating receptor CD16 on γδ T lymphocytes was observed, substantiating a potential synergy of the mechanisms of action of IPH 1101 and rituximab.
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