The US FDA has approved penpulimab-kcqx, a programmed death receptor-1-blocking antibody, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). It has also been approved as a single agent for adults with metastatic non-keratinizing NPC whose disease has progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.

Clinical evidence In a clinical trial involving 219 patients, penpulimab-kcqx combined with cisplatin or carboplatin and gemcitabine achieved a progression-free survival of 9.6 months, significantly longer than the 7.0 months observed with placebo combined with cisplatin or carboplatin and gemcitabine. In a second study, single-agent penpulimab-kcqx demonstrated a 28% objective response rate in patients with…