ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi®) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the authorization of marketing of ZYNLONTA® (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The CHMP’s positive opinion is now sent back to the European Commission for approval.
Earlier this year, ADC Therapeutics announced an exclusive license agreement with Sobi for the development and commercialization of ZYNLONTA for all hematology and solid tumor indications in Europe and certain international territories.
“The positive CHMP opinion is evidence of significant progress in providing ZYNLONTA to DLBCL patients in Europe,” said Amet Mallik, CEO of ADC Therapeutics. “Together with our partners, we are committed to making ZYNLONTA available to as many patients as possible worldwide and we look forward to the final decision from the European Commission, which is expected in the fourth quarter of 2022.”
“Today’s announcement marks an important step towards addressing the critical needs of patients with relapsed or refractory large B-cell lymphoma in the EU,” said Anders Ullman, Director of Research and Development and medical director at Sobi. “We are confident that Sobi’s history and strong presence in the hematology field will provide a competitive framework to be able to provide loncastuximab tesirine to more patients. »
Advisory is based on data from LOTIS-2, a large, multinational, single-arm Phase 2 (n=145) clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory DLBCL after two lines of therapy systemic or more. In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ZYNLONTA as the first antibody-drug conjugate (ADC) targeting CD19 as a single-agent therapy for adult patients with Relapsed or refractory DLBCL after two or more lines of systemic therapy. In September 2021, the European Commission granted ZYNLONTA Orphan Drug Designation for the treatment of DLBCL.
“The results of the LOTIS-2 study demonstrated significant clinical benefit for patients with recurrent diffuse large B-cell lymphoma, an aggressive subtype of non-Hodgkin’s lymphoma,” said John Radford, professor of medical oncology at the University of Manchester and the Christie NHS Foundation Trust in Manchester, UK. “The potential of ZYNLONTA is encouraging to help this undertreated patient population. If approved by the European Commission, ZYNLONTA will offer a new treatment option for patients with this difficult-to-treat lymphoma and give them and their families hope. »
ADC Therapeutics has entered into an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. Additionally, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and market ZYNLONTA in Greater China and Singapore. Overland ADCT BioPharma is currently conducting a pivotal registrational Phase 2 clinical trial of ZYNLONTA for the treatment of relapsed or refractory DLBCL in China.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is an antibody-drug conjugate (ADM) targeting CD19. Once bound to a cell expressing CD19, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. This potent payload binds to the DNA minor groove with low distortion, thus remaining less visible to DNA repair mechanisms. This results in cell cycle arrest and tumor cell death.
The FDA has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma to two or more lines of systemic therapy, including unspecified DLBCL , DLBCL resulting from low-grade lymphoma as well as high-grade B-cell lymphoma. The trial included a wide range of intensively pretreated patients (median number of prior treatments was three) and with difficult to treat disease, including patients unresponsive to first-line treatment, refractory to all prior first-line therapies, patients with a double/triple genetic event, and patients who underwent stem cell transplantation and CAR-T cell therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under the accelerated clearance procedure based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of observed clinical benefits in a confirmatory trial.
ZYNLONTA is also being evaluated in combination with previous therapeutic lines and in other B-cell malignancies.
About ADC Therapeutics
ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company that improves the quality of life for people with cancer through its next-generation targeted antibody-drug conjugates (ADCTs). The Company leverages its proprietary CAM technology, based on PBDs, to transform the therapeutic paradigm for patients with hematological malignancies and solid tumors.
ADC ZYNLONTA® (loncastuximab tesirine-lpyl) targeting CD19 from ADC Therapeutics is FDA approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma after at least two lines of systemic therapy. ZYNLONTA is also being developed in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin’s lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple CAMs in clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has a presence 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 Sobi
Sobi is a global specialty biopharmaceutical company working to transform the lives of people with rare diseases. Providing sustainable access to innovative medicines in the fields of hematology, immunology and specialized care, Sobi has approximately 1,600 employees in Europe, North America, the Middle East and Asia. In 2021, its turnover reached SEK 15.5 billion. Its shares (STO:SOBI) are listed on Nasdaq Stockholm. More information about Sobi is available on sobi.com, LinkedIn and YouTube.
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