Innate pulls back on lacutamab monotherapy for PTCL after efficacy letdown

2024-03-21

临床2期临床结果ASH会议

Innate Pharma disclosed Thursday that it is ending its pursuit of lacutamab as monotherapy in peripheral T-cell lymphoma (PTCL) after the anti-KIR3DL2 antibody fell short in a Phase Ib trial. The setback has prompted the company to refocus its efforts on evaluating lacutamab in combination regimens for this indication.

The move comes over two months after the FDA lifted a partial clinical hold on studies of the drug following a patient death in the Phase II TELLOMAK study. That trial is investigating lacutamab in patients with cutaneous T-cell lymphoma (CTCL), including both Sézary syndrome and mycosis fungoides. A review by the FDA subsequently determined that the fatal case was tied to aggressive disease progression and was unrelated to lacutamab, according to Innate.

The company noted that "despite objective responses observed" in the monotherapy trial of patients with KIR3DL2-expressing refractory/relapsing PTCL, it will "not be reopened to recruitment as the prespecified threshold for meaningful clinical activity was not reached."

Innate suggested it is nevertheless forging ahead with a combination strategy for lacutamab in this indication. The investigator-sponsored Phase II KILT trial is ongoing testing the drug in combination with chemotherapy, versus chemotherapy alone, in patients with KIR3DL2-expressing relapsed/refractory PTCL.

Innate highlighted preclinical data presented at last year's American Society of Hematology (ASH) congress pointing to a "synergistic effect" between lacutamab and chemotherapy in preclinical models of PTCL, supporting the rationale for moving forward with a combination strategy.

At ASH, Innate also reported final data from the TELLOMAK study, where lacutamab was associated with a global confirmed objective response rate (ORR) of 37.5% in a heavily pre-treated population of patients with Sézary Syndrome. ORRs in the skin and blood were 46.4% and 48.2%, respectively, with median progression-free survival of 8 months.

Innate said top-line results from TELLOMAK in mycosis fungoides will be reported at a medical conference this year.

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