Anti‑PD‑1 antibody penpulimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: a randomized, double‑blind phase 3 study

Rákkutatás · Nasopharyngeal carcinoma

Penpulimab combined with standard gemcitabine‑cisplatin or carboplatin chemotherapy significantly prolonged progression‑free survival compared with placebo plus chemotherapy in patients with first‑line recurrent or metastatic nasopharyngeal carcinoma.

In this phase 3 trial, penpulimab combined with chemotherapy was assessed against a regimen of placebo plus chemotherapy for the first‑line treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). 291 patients were randomised and allocated in a 1:1 ratio in order to receive penpulimab (n = 144; 200 mg) or placebo (n = 147; 200 mg), plus chemotherapy (cisplatin/carboplatin and gemcitabine) every 3 weeks. Patients followed by maintenance therapy with penpulimab or placebo after 6 cycles. The primary endpoint of this study was progression‑free survival (PFS) according to RECIST v1.1, and a significantly longer median PFS in the penpulimab arm versus the placebo arm (9.63 versus 7.00 months; hazard ratio 0.45, 95% CI: 0.33–0.62, P < 0.0001) was demonstrated in this prespecified interim analysis.

This study confirms that for patients with R/M NPC, combination therapy with penpulimab and standard chemotherapy greatly enhances PFS versus chemotherapy alone, which met its primary endpoint.

Bizonyítékszint: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.

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