Roche | MEDIA
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Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer
Tambotatug pelitecan (Tam-Peli) has shown significant efficacy in a Phase III study in China for relapsed small-cell lung cancer. The drug demonstrated a 54% reduction in the risk of death and a 71% reduction in disease progression compared to topotecan. Tam-Peli achieved an objective response rate of 59.1%, vastly outperforming topotecan's 9.7%. This novel antibody-drug conjugate targets B7-H3 and utilizes MediLink's TMALIN platform for targeted delivery. Roche is responsible for the global commercialization of Tam-Peli outside of specific regions in China. Both the U.S. FDA and China CDE have granted Breakthrough Therapy Designations for Tam-Peli in relapsed small-cell lung cancer. The interim results of the TAISHAN-302 trial are being presented at the IASLC World Conference on Lung Cancer. China's regulatory agency has accepted Tam-Peli's New Drug Application for filing. Tam-Peli also showed a favorable safety profile with lower rates of serious treatment-related adverse events. Consistent improvements were observed across various patient subgroups, including those with brain metastases.