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Overland ADCT BioPharma has commenced a pivotal Phase 2 clinical trial in China, dosing the first patient with ZYNLONTA® for relapsed or refractory diffuse large B-cell lymphoma. Following its FDA accelerated approval in April 2021, ZYNLONTA stands as the first CD19-targeted antibody drug conjugate for adult patients post multiple systemic therapies. This trial aims to validate ZYNLONTA's efficacy and safety, facilitating its potential registration in China. Overland ADCT is committed to addressing the unmet medical need for patients with r/r DLBCL in Asia.
Positive
Initiation of pivotal Phase 2 trial for ZYNLONTA in China, expanding its clinical reach.
ZYNLONTA is the first FDA-approved CD19-targeted ADC, offering significant treatment options.
Clinical trials have shown strong activity in patients with relapsed or refractory DLBCL.
Negative
None.
BOSTON & SHANGHAI & LAUSANNE, Switzerland--(BUSINESS WIRE)--
Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), today announced the first patient has been dosed with ZYNLONTA®in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in China. In April 2021, ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as the first and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with r/r DLBCL after two or more lines of systemic therapy. This local pivotal study mirrors ADC Therapeutics’ ongoing global pivotal Phase 2 clinical trial of ZYNLONTA and its results are intended to support the potential registration of ZYNLONTA in China.
“After receiving early FDA approval of ZYNLONTA in April, we are pleased that our colleagues at Overland ADCT BioPharma have rapidly initiated a pivotal study to potentially benefit patients in China,” said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. “We are eager for this bridging study to be completed, and we hope that ZYNLONTA will ultimately be available to all patients who can benefit from it globally.”
“Dosing the first patient in this pivotal trial is a key milestone for Overland ADCT BioPharma as we collaborate to expand the clinical reach of ZYNLONTA in greater China and Singapore,” said Eric Koo, Chief Executive Officer of Overland ADCT BioPharma. “With many patients in China affected by r/r DLBCL, we remain committed to addressing this unmet medical need and delivering promising antibody drug conjugates for underserved patients around the world. Together with ADC Therapeutics, we look forward to the continued development and commercialization of ZYNLONTA in Asia.”
ZYNLONTA, Overland ADCT BioPharma’s lead product candidate, is an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. In clinical trials, ZYNLONTA has demonstrated significant single-agent clinical activity across a broad population of patients with r/r DLBCL, mantle cell, and follicular lymphomas.
The China Phase 2, multi-center, open-label, single-arm study will evaluate the efficacy and safety of ZYNLONTA used as monotherapy in patients with r/r DLBCL.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® 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. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. 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.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
About Overland ADCT BioPharma
Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics, is developing and commercializing four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – ZYNLONTA, ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore.
About ADC Therapeutics
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.
ADC Therapeutics is based in Lausanne (Biopôle), 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 registered trademark of ADC Therapeutics SA.
About Overland Pharmaceuticals
Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging its resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine. www.overlandpharma.com
ADC Therapeutics Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, planned commercialization activities, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
What is the purpose of the Phase 2 trial for ADCT's ZYNLONTA?
The Phase 2 trial aims to evaluate the efficacy and safety of ZYNLONTA as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma in China.
When was ZYNLONTA approved by the FDA?
ZYNLONTA received accelerated FDA approval in April 2021 as the first CD19-targeted ADC for adult patients after two or more lines of systemic therapy.
What are the expected outcomes of the ZYNLONTA trial in China?
The trial's results are intended to support the potential registration of ZYNLONTA in China and address the medical need for patients with relapsed or refractory DLBCL.
How does ZYNLONTA work as a treatment for DLBCL?
ZYNLONTA is an antibody drug conjugate that targets CD19 on cancer cells, delivering a cytotoxic payload that leads to tumor cell death.
What is the significance of the first patient being dosed in the trial?
Dosing the first patient is a key milestone for Overland ADCT BioPharma, signifying progress in bringing ZYNLONTA to patients in need in China.
