China’s National Medical Products Administration has approved izalontamab brengitecan for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) whose disease has progressed after platinum-based chemotherapy and immunotherapy. The approval is a major milestone, making iza-bren the world’s first approved bispecific antibody-drug conjugate (ADC).
The decision is based on results from the phase 3 PANKU-NPC01 Trial, which compared iza-bren with standard chemotherapy chosen by physicians. Patients treated with iza-bren achieved a response rate of 54.6%, compared with 27.0% for chemotherapy. The treatment also nearly doubled median progression-free survival to 8.38 months, versus 4.34 months with chemotherapy. Responses lasted longer as well, with a median duration of 8.5 months compared with 4.8 months. Overall survival data are still being collected.
Serious treatment-related side effects were more common with iza-bren than chemotherapy, mainly involving blood-related complications. Dose interruptions occurred in more than half of patients receiving iza-bren, and four treatment-related deaths were reported. However, most non-blood-related side effects were mild, and no new safety concerns were identified.