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.