Innate Pharma has reported data from the ongoing Phase II TELLOMAK clinical trial where its anti-KIR3DL2 antibody, lacutamab (IPH4102), showed clinical responses in advanced mycosis fungoides (MF) patients.
Based on data from the international, multi-cohort, open-label trial, it was observed that the antibody produced a global objective response rate (ORR) of 28.6% in the KIR3DL2-expressing MF patients.
The results also included two complete responses and four partial responses.
Innate Pharma chief medical officer Joyson Karakunnel said: “We are pleased to see that lacutamab continues to show clinical activity in these heavily-pretreated patients with mycosis fungoides, confirming our hypothesis that lacutamab, a KIR3DL2 targeted agent, could provide benefit to patients with tumours expressing the target.
“We look forward to sharing final data from the TELLOMAK Phase II trial in both Sézary syndrome and mycosis fungoides in 2023, and progressing the two additional trials that are ongoing with lacutamab in Peripheral T cell lymphoma.”
Lacutamab showed a favourable safety profile in MF also in the skin, which is in line with earlier observations.
In 2/39 (5.1%) of patients, grade ≥ 3 treatment-related (TR) treatment-emergent adverse events (TEAEs) were observed. Due to adverse events, 1/39 (2.6%) of patients discontinued the study drug.
Asthenia, arthralgia, and nausea were the most common TR TEAEs observed.
Lacutamab is currently in clinical trials to treat cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL).
The TELLOMAK trial is recruiting subjects with Sézary syndrome and MF in the US and Europe.
In total, the MF cohorts are set to recruit nearly 100 patients.
Objective global response rate is the trial’s primary endpoint while the key secondary endpoints are duration of response, progression-free survival, overall survival, quality of life, and pharmacokinetics, along with immunogenicity and adverse events.
In July last year, Innate Pharma decided to suspend the development of its drug candidate, avdoralimab, to treat Covid-19 after its Phase II FORCE clinical trial could not meet the primary endpoints.