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Reported Saturday, Roche's B7-H3-Targeted ADC Tam-Peli Meets Primary Endpoint In Phase III TAISHAN-302 Trial, China's NMPA Accepts New Drug Application For Filing

Benzinga·09/14/2026 05:48:32
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  • Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7%1
  • The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload is based on MediLink’s proprietary TMALIN® platform, designed to maximise antitumour activity while minimising off-target toxicity2,3
  • Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong, and Macau across multiple tumour types, with plans to rapidly initiate global trials
  • Tam-Peli has received U.S. FDA and China CDE Breakthrough Therapy Designations for relapsed small-cell lung cancer (SCLC)