New Treatment of Resistant Sézary Syndrome Granted FDA Fast Track Designation
Posted: Thursday, January 31, 2019
On January 29, 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. IPH4102 is a first-in-class anti-KIR3DL2 antibody developed for the treatment of T-cell lymphoma.
This Fast Track designation is based on the preliminary results of the phase I dose-escalation and expansion study (ClinicalTrials.gov identifier NCT02593045) of IPH4102 in 44 patients with advanced cutaneous T-cell lymphoma. As of October 15, 2018, data from the subgroup of 35 patients with Sézary syndrome revealed clinical activity, demonstrated by an overall response rate of 42.9%, a median duration of response of 13.8 months, and a median progression-free survival of 11.7 months. The overall response rate appeared to be higher (53.6%) in the 28 patients with no histologic evidence of large cell transformation. Clinical activity was associated with an improvement in quality of life, as assessed by the Skindex-29 and Pruritus Visual Analog Scale scores. The safety profile of IPG4102 was reported to be consistent with previous observations.
A global, open-label, multicohort phase II trial (TELLOMAK) is planned, with an estimated 250 patients with different subtypes of T-cell lymphoma to be recruited. IPH4102 will be evaluated as a single agent in patients with Sézary syndrome and mycosis fungoides as well as in combination with standard chemotherapy (gemcitabine and oxaliplatin) in patients with peripheral T-cell lymphoma.