New Drug: Penpulimab with Platinum – Gemcitabine in Advanced Nasopharyngeal Carcinoma

Global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)

Previously untreated recurrent or metastatic nasopharyngeal carcinoma (R/M NPC)

Penpulimab + gemcitabine/cisplatin or carboplatin vs. placebo + gemcitabine/cisplatin or carboplatin

ORR: 68.1% vs. 63.9% (penpulimab vs. placebo)

mDoR: 9.8 mos vs. 5.7 mos (HR: 0.40 [0.27–0.59])

mPFS: 9.6 mos vs. 7.0 mos (HR: 0.45 [0.33–0.62])

OS (unadjusted): HR: 0.94 [0.63–1.40]

OS (adjusted for cross-over, RPSFT model): HR: 0.62 [0.41–0.94] (RPSFT)

Grade ≥3 TRAEs: 89.0% vs. 85.9%

SAEs: 50.7% vs. 48.6%

irAEs: 30.8% vs. 8.5%

Grade ≥3 irAEs: 4.1% vs. 0%

Hu C,Chen X,Xu T Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)

Reviewed by Ulas D. Bayraktar, MD on Jun 9, 2025