KEYNOTE-122

NCT02611960 📎

Regimen

Experimental
Pembrolizumab 200 mg IV q3w until progression or 2 years
Control
Investigator-choice chemotherapy (capecitabine, gemcitabine, or docetaxel)

Population

Platinum-pretreated recurrent or metastatic NPC; PD-L1 positive (CPS ≥1); prior platinum-based chemotherapy (most from Asian centers)

Key finding

KEYNOTE-122 was a negative phase 3 trial: pembrolizumab monotherapy did not significantly improve OS versus chemotherapy in platinum-pretreated RM NPC, despite promising earlier signals from KEYNOTE-028. The HR of 0.90 showed no meaningful difference. Grade ≥3 toxicity was substantially lower with pembrolizumab (10.3% vs 43.8%), but the primary OS endpoint was missed. This negative result is clinically crucial: it established that PD-1 monotherapy as a substitute for chemotherapy in 2L RM NPC does not work, which is why the 1L chemo-IO combination strategy was the correct approach.

Source: PMID 36535566

Timeline

    Guideline citations

    • NCCN NPC (p.245)