Roche Holding AG reported positive interim results from the Phase III TAISHAN-302 trial for Tam-Peli (tambotatug pelitecan). The study, conducted in China with partner MediLink, evaluated the treatment for relapsed small-cell lung cancer.
Tam-Peli met its primary endpoint of overall survival. The drug reduced the risk of death by 54% compared to the standard-of-care chemotherapy, topotecan.
The trial also met secondary endpoints for progression-free survival and objective response rates. Based on these results, China’s Center of Drug Evaluation has accepted the New Drug Application for Tam-Peli for filing.
Roche plans to initiate global Phase III trials for the B7-H3-targeted antibody-drug conjugate. The company will further develop the treatment for multiple tumor types.