The trial is expected to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration.
“We are pleased to have dosed the first patient in our registrational Phase II clinical trial evaluating ADCT-402 in patients with DLBCL who have relapsed and have refractory disease after two or more multi-agent treatment regimens,” Jay Feingold, an MD and PhD, chief medical officer and senior vice president of clinical development at ADC Therapeutics, said in a press release.
ADCT-402 belong to a class to drugs called antibody-drug conjugates, which consist of a cancer-targeting antibody bound to toxic compound.
ADCT-402 binds to CD19, a molecule present on the surface of many types of blood cancer cells, and carries the pyrrolobenzodiazepine (PBD) dimer toxin, which is able to kill cancer cells once taken up.
The interim data of a Phase 1 trial (NCT02669017), presented last year at the 2017 American Society of Hematology (ASH) Annual Meeting, showed ADCT-402 induced responses in more than half of patients.
The trial included 138 patients with B-cell non Hodgkin’s lymphoma (NHL) who had relapsed or failed to respond to prior therapies.
During the dose escalation phase (Part 1) of the study, patients who received ADCT-402 at doses equal or greater than 120 micrograms/kg achieved an overall response rate of 55 percent, including complete responses in 37 percent of participants.
“In this Phase 1 study, [ADCT-402] has demonstrated encouraging single-agent anti-tumor activity and manageable toxicity in [patients] with [relapsed or refractory] B-cell lineage NHL. Evaluation in specific NHL subtypes is now warranted, and a dose expansion in [patients] with DLBCL is planned initially,” investigators wrote in their abstract.
The findings led to the newly initiated Phase 2 trial (NCT03589469), which is testing the compound in DLBCL, the most common subtype of non-Hodgkin’s lymphoma in adults.
The trial’s main objective is to determine the response rate in DLBCL patients who failed two or more prior therapies. Secondary measures include duration of response, complete response rate, relapse-free survival, progression-free survival and overall survival, as well as safety and quality of life.
The trial is estimated to last approximately two years and to enroll 140 patients from multiple centers in the U.S. and Europe.
“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,” Feingold said.
The company also said it is planning to launch multiple combination studies with ADCT-402 in the fourth quarter of 2018.