The China NMPA has approved the New Drug Application (NDA) for Zevor-cel. This autologous CAR-T product targets BCMA and is intended for adult patients with relapsed or refractory multiple myeloma who have not responded to at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Zevor-cel is developed by transducing T cells with a lentivirus that encodes a CAR featuring a fully human BCMA-specific single-chain variable fragment (scFv), a human CD8α hinge domain, CD8α transmembrane domain, 4-1BB co-stimulatory domain, and a CD3ζ activation domain. The proprietary fully-human scFv demonstrates high binding affinity and stability.
The approval is based on findings from an open-label, single-arm, multi-center Phase II clinical trial (LUMMICAR STUDY 1, NCT03975907) conducted. Results were presented at the 2022 Annual Meeting of the American Society of Hematology (ASH), highlighting zevorcabtagene autoleucel’s encouraging efficacy and favorable safety profile.
Multiple myeloma, which accounts for about 10% of all hematological cancers, remains an incurable disease. With China’s aging population and increasing life expectancy, the number of multiple myeloma cases is expected to rise. According to Frost & Sullivan, the prevalence of multiple myeloma in China is estimated at approximately 153,000 in 2023, with new cases projected at 23,200 annually. This number is anticipated to grow to 266,300 by 2030.
Prof. Wenming Chen, principal investigator of the LUMMICAR STUDY 1 and Director of the Hematology Department at Beijing Chao-Yang Hospital, stated, “The prognosis for patients with relapsed or refractory multiple myeloma is often grim due to limited treatment options. The approval of zevorcabtagene autoleucel not only broadens the choices for clinicians but also brings new hope to patients facing significant unmet clinical needs.”
Prof. Chengcheng Fu, also a principal investigator of the study and Director of the Hematology Department at the First Affiliated Hospital of Soochow University, added, “Zevorcabtagene autoleucel has shown profound and lasting therapeutic efficacy in patients, with an overall favorable safety profile. We are excited about its regulatory approval and the potential to help many more patients achieve long-term survival.”
Dr. Zonghai Li, Founder, Chairman, CEO, and Chief Scientific Officer of CARsgen Therapeutics, remarked, “This year marks the tenth anniversary of CARsgen, and I am thrilled to announce the NDA approval of zevorcabtagene autoleucel. This milestone reflects our team’s dedication and hard work. We are grateful to our team members, investigators, patients, and the wider community for their support. We look forward to zevorcabtagene autoleucel bringing renewed hope to adults with relapsed or refractory multiple myeloma, enhancing their survival rates. Guided by our vision of ‘Making Cancer Curable,’ we are committed to exploring new technologies and expanding our product pipeline to tackle the challenges of CAR T-cell therapies.”
