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Clinical Trials

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-301

Action mechanism:

  • antibody drug conjugate. ADCT-301 combines HuMax®-TAC™, a monoclonal antibody targeting CD25 (the alpha chain of the IL-2 receptor) created by Genmab, with a pyrrolobenzodiazepine (PBD) warhead. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at low single doses. It also outperformed Adcetris™ (brentuximab vedotin), an ADC approved for treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma, in animal models. In preclinical studies the PBD warhead has been shown to be a highly potent killer of cancer cells even when such cancer cells are resistant to current best therapies.
  • ADC Therapeutics has a license to the PBD warheads from Spirogen now owned by MedImmune, and the HuMax®-TAC™ antibody was developed by Genmab under license from Medarex. In June 2013, Genmab and ADC Therapeutics entered into a Collaboration and License Agreement for the development of ADCT-301, and Genmab holds a 25% ownership share in ADCT-301. No other financial terms were disclosed.

Disease: relapsed/refractory Non-Hodgkin or Hodgkin lymphoma

Therapeutic area: Cancer - Oncology

Country: UK, USA

Trial details: This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive escalating doses of ADCT-301 every 3 weeks. In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks. (NCT02432235)

Latest news:

  • • On June 16, 2017, ADC Therapeutics announced that the interim data from an ongoing Phase I clinical trial evaluating ADCT-301 for the treatment of relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma has been presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
  • In a poster session at the 14th ICML, interim results from the ongoing Phase I, open label, dose-escalating study of ADCT-301 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma (r/r HL/NHL) were presented. Data were reported from 37 extensively pretreated patients with a median age of 46 years, a median treatment duration of 43 days and 2 treatment cycles. Among all patients enrolled at the time of the data cutoff for presentation and evaluable for safety, the most common treatment emergent adverse events have been related to skin and decreased blood counts. The overall response rate for evaluable patients with HL treated with doses 30µg/kg was 38.5% while 8 of 25 (32%) efficacy evaluable patients at all dose levels with HL and NHL have achieved stable disease as their best response. ADCT-301 was well tolerated and toxicities manageable. Dose escalation continues.
  • • On March 16, 2015, ADC Therapeutics announced that it has filed an Investigational New Drug application (IND) with the FDA as it moves its pipeline into clinical development. The IND is for a Phase I clinical trial for ADCT-301, a novel antibody drug conjugate targeting CD25, a cell-surface antigen, which is over-expressed in many patients with lymphomas. The Phase I clinical trial will commence at four leading oncology centres in the USA, and can expand into two centres in the United Kingdom. The initial up to 58 patient adaptive designed dose-escalation study, will evaluate the tolerability, safety, pharmacokinetics and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin’s and Non-Hodgkin’s lymphoma. Subject to study results, ADC Therapeutics intends to rapidly expand the numbers of patients in the trial and the participating clinical centres. Simultaneously, Genmab announced it has decided not to exercise the co-development right for HuMax-TAC-ADC under its agreement with ADC Therapeutics.

Is general: Yes