Micrograph of a diffuse large B-cell lymphoma. Credit: Nephron.

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).

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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.

“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.”

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.”

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“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.

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