Date: 2017-06-16
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 14th International Conference on Malignant Lymphoma (ICML)
Company: ADC Therapeutics (Switzerland)
Product: ADCT-402
Action
mechanism: antibody drug conjugate. ADCT-402 is an anti-CD19 PBD-conjugate, with presented data demonstrating potent and specific in vitro and in vivo anti-tumor activity against CD19-positive hematological tumors as well as excellent tolerability.
Disease: relapsed or refractory non-Hodgkin's lymphoma
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On June 16, 2017, ADC Therapeutics announced that the first clinical data from an ongoing Phase I clinical trial evaluating ADCT-402 for the treatment of relapsed or refractory non-Hodgkin's lymphoma has been presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. ADCT-402 is a novel antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated to ADCT's highly potent proprietary pyrrolobenzodiazepine (PBD) dimer toxin. CD19 is highly expressed in a wide range of B-cell hematological tumors, including certain forms of lymphomas and leukemias, while its expression in healthy tissues is restricted.
In a presentation at the 14th ICML, interim results from the Phase I, open label, dose-escalating study of ADCT-402 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) were reported. Data were presented from 62 evaluable patients with a median age of 67 years and 3 previous therapies. Among the patients enrolled at the time of the data cutoff for presentation, ADCT-402 has been reasonably well tolerated with the most common treatment emergent adverse events (TEAEs) being fatigue, neutropenia and thrombocytopenia which have been treated symptomatically and, in some cases, with dose delays, reductions and discontinuation.
- The overall response rate with doses (120µg/kg was 61% in the total patient population and 57% in patients with relapsing or refractory diffuse large B-cell lymphoma (DLBCL). The maximum tolerated dose has not yet been reached.
Is
general: Yes
