Full Press Release Details
Presents Updated Clinical Data
at 2021 ASCO Annual Meeting
LOTIS-2 updated data includes median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory
include patients with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients
LAUSANNE, Switzerland,
June 4, 2021 - ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel
antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced updated clinical data from the
ZYNLONTA (loncastuximab tesirine-lpyl) Phase 2 LOTIS-2 trial in patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL) were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually June 4-8,
duration of response from the ZYNLONTA Phase 2 trial reported at ASCO reflects the strong data set that served as the basis of the accelerated
FDA approval in April," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We
are especially encouraged to see this positive trend continue to strengthen in a heavily pre-treated patient population, including patients
with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients older than 65."
In LOTIS-2, a single-arm,
open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed 2 established therapies,
ZYNLONTA demonstrated continued substantial antitumor activity and an acceptable safety profile. Updated results, including analysis
of response in high-risk subgroups, were presented in a poster (abstract number: 7546) by Paolo F. Caimi, MD, University Hospitals Cleveland
Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University.
March 1, 2021 data cut include:
posters presented at the 2021 ASCO Annual Meeting:
(loncastuximab tesirine-lpyl)
is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes
release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible
to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA)
has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell
lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),
DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval
based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
The FDA approval was based on data from LOTIS-2,
a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following
two or more prior lines of systemic therapy. The trial included a broad spectrum of heavily pre-treated patients (median three prior
lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial also enrolled
patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, and patients who had stem cell
transplants and CAR-T therapy prior to their treatment with ZYNLONTA. Results from the trial demonstrated an overall response rate (ORR)
of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of
24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the most recent data cut-off for patients enrolled
in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled safety population the most common adverse
reactions ( 20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation,
fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common ( 10%) grade 3 treatment-emergent
adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).
ZYNLONTA is being evaluated in combination
for earlier lines of therapy and as a monotherapy in other B-cell malignancies.
About ADC Therapeutics
(NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody
drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients
with hematologic malignancies and solid tumors.
CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse
large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with
other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory
and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, the Company has multiple PBD-based
ADCs in ongoing clinical and preclinical development.
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 and LinkedIn.
ZYNLONTA is a trademark of ADC