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Overland ADCT BioPharma has initiated its Phase 3 LOTIS-5 trial in China, dosing the first patient with ZYNLONTA® combined with rituximab for DLBCL. This follows ZYNLONTA's accelerated FDA approval as a single-agent therapy for relapsed DLBCL. The trial aims to support a supplemental BLA in the U.S. and China for transplant-ineligible patients. This significant milestone reflects the commitment to advancing treatment options for patients with difficult-to-treat DLBCL in China.
Positive
First patient dosed in the Phase 3 LOTIS-5 trial, indicating progress in clinical research.
ZYNLONTA has FDA accelerated approval for relapsed DLBCL, enhancing its market potential.
The trial addresses a crucial need, as over half of DLBCL patients in China are not eligible for stem cell transplantation.
Negative
None.
LOTIS-5 is intended to serve as the basis for a supplemental BLA (sBLA) in the U.S. and China in second-line transplant ineligible DLBCL
BOSTON & SHANGHAI & LAUSANNE, Switzerland--(BUSINESS WIRE)--
Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals (“Overland”) and ADC Therapeutics SA (NYSE: ADCT), today announced the first patient has been dosed in China with ZYNLONTA® in combination with rituximab compared to standard immunochemotherapy in the LOTIS-5 confirmatory Phase 3 global clinical trial in second-line or later, transplant ineligible patients with diffuse large B-cell lymphoma (DLBCL).
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 relapsed or refractory DLBCL after two or more lines of systemic therapy. The joint venture has now joined the LOTIS-5 global confirmatory Phase 3 clinical trial of ZYNLONTA, which is intended to support a supplemental Biologics License Application (sBLA) for ZYNLONTA in the U.S. and China in second-line, transplant-ineligible patients.
“Dosing the first patient in this Phase 3 trial is a significant achievement for Overland ADCT BioPharma and for patients with diffuse large B-cell lymphoma (DLBCL) in China,” said Eric Koo, Chief Executive Officer of Overland ADCT BioPharma. “This is the second study we have initiated with ZYNLONTA, demonstrating our commitment to DLBCL patients who want and need new treatment options.”
“More than half of the patients with relapsed or refractory DLBCL in China are not eligible for hematopoietic stem cell transplantation (HSCT) and thus do not have an effective therapeutic option,” said the principal investigator of the Phase 3 trial, Professor Qiu Lugui, Director of Lymphoma Diagnosis at the Treatment Center of Hematology Hospital of Chinese Academy of Medical Sciences. “This trial is a significant advancement in the treatment of r/r DLBCL in China. We look forward to bringing ZYNLONTA to all patients who can benefit from it.”
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 lymphoma and follicular lymphoma.
“We are thrilled to see how quickly our colleagues at Overland ADCT BioPharma are advancing clinical trials with ZYNLONTA,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Our goal is to ensure we maximize the potential of ZYNLONTA to treat patients with lymphoma around the world.”
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 four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), 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 those affected by cancer 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 our 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 commercial strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, 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.
The LOTIS-5 trial is a Phase 3 clinical study evaluating ZYNLONTA® combined with rituximab for DLBCL patients who are ineligible for transplant.
When was ZYNLONTA first approved by the FDA?
ZYNLONTA was granted accelerated FDA approval in April 2021 for the treatment of relapsed DLBCL.
What is the significance of the first patient being dosed in the LOTIS-5 trial?
Dosing the first patient marks a significant achievement for Overland ADCT BioPharma and the advancement of treatment options for DLBCL in China.
How does the LOTIS-5 trial benefit patients in China?
The trial aims to provide treatment options for DLBCL patients in China, specifically those who are not eligible for hematopoietic stem cell transplantation.
What are the next steps following the LOTIS-5 trial initiation?
The results from the LOTIS-5 trial will support a supplemental BLA for ZYNLONTA in the U.S. and China.
