Roche's partner Medilink has released positive Phase III data for Tam-Peli (tambotatug pelitecan) in patients with relapsed small-cell lung cancer, with the treatment cutting the risk of death by 54% compared with the standard drug topotecan.
The results, announced on Sunday night, also showed a 71% reduction in the risk of disease progression. Roche said the study's primary endpoint had been met.
The Taishan-302 trial enrolled 451 patients in China and compared Tam-Peli against topotecan in subjects whose cancer had recurred after prior chemotherapy. Median overall survival was 13.3 months with Tam-Peli versus 9.4 months with topotecan. The objective response rate stood at 59.1% compared with 9.7%.
The findings will be presented at a lung cancer conference in Seoul and published simultaneously in the New England Journal of Medicine.
Tam-Peli is an antibody-drug conjugate that targets B7-H3, a protein commonly found on cancer cells. It has not yet received regulatory approval.
Roche develops and markets Tam-Peli outside mainland China, Hong Kong and Macau and plans to launch global Phase III studies shortly. In the United States the drug holds FDA breakthrough therapy designation, a status reserved for treatments showing particularly promising early results.
