On August 27, 2024 Legend Biotech (NASDAQ: LEGN), a subsidiary of GenScript Biotech Corporation (hereinafter referred to as "GenScript"), a global leader in life sciences research and manufacturing services, reported that they have received approval from the China National Medical Products Administration (NMPA) for its cell therapy product, ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, AUG 27, 2024, View Source [SID1234646135]). This groundbreaking treatment is approved for use in adult patients with relapsed or refractory multiple myeloma (MM) who have previously undergone at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent. The approval of cilta-cel provides a novel treatment for patients in China who have not benefit from traditional therapies.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Cilta-cel is a gene-modified autologous chimeric antigen receptor T cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It is administered via intravenous infusion. Cilta-cel features a unique CAR structure composed of two BCMA-targeting, heavy-chain, single-domain antibodies. This design allows cilta-cel to bind the BCMA-expressing myeloma cells, and induce activation and proliferation of T cells to eliminate tumor.
Legend Biotech CEO Ying Huang stated: "The approval of cilta-cel in China market marks a key milestone and will bring significant benefits to many patients. Moving forward, we will continue to pursue our goal of curing patients, expand our clinical research, and enhance the accessibility of this innovative product to benefit more patients."
Ongoing Commitment to Cell Therapy Market and Innovation Strategy
The approval of cilta-cel is not only a significant milestone of GenScript and Legend Biotech but also a response of their unwavering commitment to innovation-driven development. Sherry Shao, GenScript’s rotating CEO, said, "Innovation has always been at the heart of GenScript’s growth strategy. As the global biopharmaceutical field advances rapidly and patient needs deepen, we recognize that only through relentless innovation and unwavering dedication to cell and gene therapy can we drive the industry forward with outstanding products and services. Congratulations to Legend Biotech on its achievements. We are confident that Legend Biotech will continue to lead in cell therapy, exploring new frontiers and delivering groundbreaking innovations to the industry."
The approval is based on the outstanding results of the CARTIFAN-1 (NCT03758417) multi-center confirmatory Phase II clinical trial. This study evaluated the efficacy and safety of cilta-cel in patients with relapsed or refractory multiple myeloma.
Results from a median follow-up of 37.29 months showed that among 58 patients analyzed for efficacy, the overall response rate (ORR) was 87.9%, with very good partial response (VGPR) or better achieved in 86.2%, and complete response (CR) or stringent complete response (sCR) reached 79.3%. The median duration of response (mDOR) was 32.56 months, median progression-free survival (mPFS) was 30.13 months, and the median overall survival (mOS) was not reach the point.
Cilta-cel has demonstrated excellent clinical efficacy in trials, offering early and durable responses as well as longer PFS survival benefits in patients who failed multiple prior lines of treatment. This innovative and safe therapy represents a significant benefit for multiple myeloma patients.
This approval of cilta-cel not only highlights the technological strength of Legend Biotech but also enhances the market growth potential of GenScript and reinforces its leading position in the biotech industry. This important progress will lead the way for GenScript to continuously invest and explore in the cell therapy field, accelerate the translation of breakthrough therapies from the lab to clinical practice, and expedite the development and commercialization of innovative drugs and therapies.
With over twenty years of dedicated development and investment in the life science industry and cell and gene therapy, GenScript has built a solid foundation in these areas. GenScript is actively expanding the boundaries of life sciences and strengthening collaborations with global research institutions, medical organizations, and industry partners. By integrating resources and leveraging synergies, GenScript aims to accelerate the rapid development of the biotech industry and provide more and better treatment options for patients worldwide.