Some good news for Innate as it gets French regulator's nod to resume lacutamab trial

French oncology-focussed Innate Pharma (Euronext Paris: IPH) late yesterday announced that the French National Agency for Medicines and Health Product Safety (ANSM) has agreed that the lacutamab (IPH4102) TELLOMAK Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two lines of prior systemic therapy.

Just last week, the US Food and Drug Administration put on partial clinical hold its TELLOMAK Phase II trial, evaluating the efficacy and safety of lacutamab advanced T-cell lymphomas. The trial is also suspended in Italy

Following discussions with the company, the ANSM decision to allow new patient recruitment to resume in Sézary syndrome and MF in France is based on an assessment of the unmet medical need and the lack of currently available standard of care options. Conversely, because standard of care options are available to patients with peripheral T-cell lymphoma (PTCL), no new patients can enroll in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available. However, currently enrolled PTCL patients can continue treatment in the trial.

In light of this feedback, the company will take the operational measures to reactivate the lacutamab TELLOMAK trial in Sézary syndrome and MF in France and the UK, where regulatory agencies have authorized it.