Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lacutamab · 2 trials · 2 indications
time from randomization until one of the following events occurs, whichever comes first: 1. Disease progression (PD) 2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) 3. Relapse after achievement of CR 4. Death due to any cause. PD and relapse will be evaluated according to Lugano 2014 criteria (CT-based).
Frequency and intensity of adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Lacutamab | EXPERIMENTAL | Lacutamab 750 mg/IV + GEmOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase Lacutamab 750 mg/IV for a maximum of 20 additional cycles of 4 weeks during the maintenance phase |
| Standard of care | ACTIVE_COMPARATOR | GemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase |
| PTCL that express KIR3DL2 | EXPERIMENTAL | lacutamab will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Lacutamab | DRUG | 750 mg/IV |
| Gemcitabine | DRUG | 1000 mg/m² |
| Oxaliplatine | DRUG | 100 mg/m² |
Inclusion Criteria: * 1\. KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central evaluation by immunohistochemistry (IHC) 2. Patients with histologically documented PTCL: * Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at re...
Lacutamab is an investigational monoclonal antibody being studied for the treatment of Peripheral T Cell Lymphoma (PTCL), specifically in patients with relapsed or recurrent disease. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in patients whose tumors express the KIR3DL2 target.
Lacutamab targets KIR3DL2, a receptor expressed on malignant T cells in certain types of Peripheral T Cell Lymphoma. As a monoclonal antibody, it is designed to bind to this target on cancer cells. The drug is being studied in biomarker-selected patients whose tumors express KIR3DL2.
Lacutamab is being developed by Innate Pharma S.A., a biopharmaceutical company. The company's stock is listed under the ticker IPHA. Innate Pharma is conducting clinical trials of lacutamab in patients with Peripheral T Cell Lymphoma.
Lacutamab is currently in Phase 2 clinical development for Peripheral T Cell Lymphoma. It has received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA. The drug is investigational and has not been approved for any use.
Lacutamab is being studied in two clinical trials. NCT04984837 is a Phase 2 trial in relapsed/recurrent Peripheral T Cell Lymphoma, currently recruiting in Belgium, France, Germany, and Spain. NCT05321147 is a completed Phase 1 trial in relapsed/refractory PTCL expressing KIR3DL2, conducted in the United States and South Korea.
Lacutamab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Peripheral T Cell Lymphoma. The FDA has granted it Breakthrough Therapy, Fast Track, and Orphan Drug designations, which are intended to expedite development and review of promising therapies.