ADC Therapeutics has dosed the first patient in a Phase II clinical trial to examine the efficacy and safety of ADCT-402 (loncastuximab tesirine) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The trial, which will be conducted at various centres in the US and Europe, is expected to help ADC Therapeutics to submit a biologics licence application (BLA) to the US Food and Drug Administration (FDA ).
Around 140 patients with relapsed or refractory DLBCL are expected to be enrolled in the multi-centre, open-label, single-arm trial.
The primary objective of the trial is the overall response rate (ORR ) in patients treated with ADCT-402, as confirmed by central review.
The trial’s secondary objectives comprise evaluation of duration of response, complete response rate, relapse-free survival, progression-free survival and overall survival, as well as safety, pharmacokinetics and health-related quality of life.
ADC Therapeutics chief medical officer and clinical development senior vice-president of Jay Feingold said: “Our Phase I clinical trial of ADCT-402 in non-Hodgkin lymphoma showed significant activity in patients with DLBCL and an acceptable safety profile.”
“Unfortunately, there is no effective treatment for patients with multiple relapsed and refractory DLBCL, so we are excited about the potential to improve outcomes in these patients with ADCT-402 in a single-arm trial.
“We anticipate reporting results from the Phase II trial in the third quarter of 2019 and are hopeful that the data will support our submission of a BLA to the FDA .”
In addition, ADC Therapeutics intends to begin several combination studies with ADCT-402 in the fourth quarter of this year.