Full Press Release Details
Completes Enrollment in Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma
results anticipated in the first half of 2021
LAUSANNE, Switzerland, February
4, 2021 - ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the
development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological
malignancies and solid tumors, today announced completion of enrollment in the pivotal Phase 2 clinical trial evaluating the efficacy
and safety of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma. A total
of 117 patients have been enrolled in the trial.
At the 62nd American
Society of Hematology (ASH) Annual Meeting, the Company presented preliminary Phase 2 data consistent with Phase 1 results. Based
on 47 evaluable patients as of August 24, 2020, Cami demonstrated an 83% overall response rate and no new safety signals were
"Completing enrollment in
our pivotal trial of Cami brings us one step closer to potentially addressing an unmet need in heavily pre-treated Hodgkin lymphoma
patients," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We look
forward to reporting updated interim data from the trial in the first half of this year."
For more information about the
Phase 2 clinical trial of Cami, please visit https://clinicaltrials.gov/ (identifier
About Camidanlumab Tesirine
Camidanlumab tesirine (Cami, formerly
ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax -TAC, licensed
from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell,
Cami is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing
tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing
of neighboring tumor cells and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may
enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed
or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and
non-Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.
About ADC Therapeutics
ADC Therapeutics SA (NYSE:ADCT)
is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent
and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops
ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which
ADC Therapeutics has proprietary rights for its
targets. Strategic target selection
for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical
and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based
ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and
numerous preclinical ADCs in development.
Loncastuximab tesirine (Lonca,
formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial
for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR),
which exceeded the target primary endpoint. On November 20, 2020, the U.S. Food and Drug Administration accepted the Biologics
License Application, granting priority review and setting a Prescription Drug User Fee Act (PDUFA) target action date of May 21,
2021. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated in
a 117-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) for which preliminary
data have demonstrated an 83% ORR, consistent with the Phase 1 clinical trial. The Company is also evaluating Cami in a Phase
1b clinical trial as a novel immuno-oncology approach for the treatment of various advanced solid tumors.
ADC Therapeutics is based in Lausanne
(Biop le), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please
visit https://adctherapeutics.com/ and follow the Company on Twitter
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