In the dynamic landscape of oncology therapeutics, the latest findings published in the British Medical Journal (BMJ) have spotlighted sacituzumab tirumotecan (sac-TMT), an innovative Antibody-Drug Conjugate (ADC) targeting TROP2, as a game-changer for previously treated EGFR-mutant advanced non-small cell lung cancer (NSCLC). This breakthrough in the treatment of advanced cancers holds immense promise for patients and marks a significant stride in the global fight against lung cancer.
Sac-TMT, the first domestic ADC with global intellectual property rights, has recently achieved a significant milestone, receiving approvals in China for treating specific types of breast and lung cancers. The drug’s acceptance has opened new horizons, making it the world’s first TROP2 ADC approved for marketing in lung cancer. As the drug undergoes further clinical studies globally, the breadth and depth of its efficacy across various cancer types are being keenly explored.
Adding another feather to its cap, sac-TMT is now under review by the National Medical Products Administration for new indication applications in EGFR-mutant NSCLC and hormone receptor-positive, HER2-negative breast cancer. This development comes as a result of multiple registrational clinical studies in China, and global Phase 3 trials, aimed at evaluating sac-TMT as a monotherapy or in combination with other agents.
The BMJ publication reveals that sac-TMT outperformed docetaxel, a standard chemotherapy drug, in terms of confirmed objective response rate (ORR). The study, led by Professor Li Zhang, Deputy Director of the Lung Cancer Research Centre at Sun Yat-Sen University, and published in BMJ, showed a 45% ORR for sac-TMT, compared to just 16% for docetaxel. This outcome is not only statistically significant but also clinically meaningful.
Professor Zhang emphasized the global competitiveness of sac-TMT as a novel TROP2 ADC, noting this publication as a major milestone. He cited the challenges posed by inevitable acquired resistance of third-generation EGFR-TKIs, the current standard of care for EGFR-mutant advanced NSCLC. The promising results from sac-TMT offer a fresh therapeutic approach, overcoming these limitations.
Dr. Michael Ge, CEO of Kelun-Biotech, echoed this enthusiasm, sharing his excitement about the publication of the OptiTROP-Lung03 study in a top-tier journal. He acknowledged the current challenges in increasing efficacy while managing tolerability in the standard care for patients with EGFR-mutant advanced NSCLC. The OptiTROP-Lung03 study results underscore sac-TMT’s potential to transform the standard of care, highlighting significant survival benefits with a manageable safety profile.
The developments around sac-TMT are indicative of a broader industry shift towards precision medicine and targeted therapies. The drug’s progress underscores the power of translational medicine, bridging the gap between bench and bedside, bringing hope to patients and opening new frontiers in cancer treatment. As sac-TMT continues its journey through clinical trials, it exemplifies the potential of biotech to revolutionize cancer care, setting a new standard for the future of oncology therapeutics.
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