(Nasopharyngeal Cancer) Is Keytruda Effective in Platinum-Pretreated Recurrent or Metastatic Patients?
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At the ESMO 2021 virtual congress (September 16–21), Anthony T.C. Chan et al. from The Chinese University of Hong Kong presented the efficacy and safety results of Keytruda (pembrolizumab) in platinum-pretreated, recurrent and metastatic nasopharyngeal carcinoma (NPC) from the KEYNOTE-122 Phase 3 trial.
Trial Design
KEYNOTE-122 randomized platinum-pretreated recurrent/metastatic NPC patients (N=233) in a 1:1 ratio to:
- Keytruda group (N=117)
- Chemotherapy group (N=116)
Primary endpoint: Overall survival (OS). Secondary endpoints: PFS, ORR, duration of response.
Efficacy Results
Overall survival (primary endpoint):
- All patients: Keytruda 17.2 months / Chemotherapy 15.3 months — no significant improvement
- PD-L1-positive patients: Keytruda 17.2 months / Chemotherapy 18.0 months
- 24-month survival rate: Keytruda 40.2% / Chemotherapy 32.2%
Secondary endpoints:
- Median PFS: Keytruda 4.1 months / Chemotherapy 5.5 months — no significant difference
- ORR (all patients): Keytruda 1.4% / Chemotherapy 23.3%
- ORR (PD-L1-positive patients): Keytruda 23.0% / Chemotherapy 26.0%
- Median duration of response: Keytruda 12.0 months / Chemotherapy 13.1 months
Safety Profile
- Overall adverse event rate: Keytruda 61.2% / Chemotherapy 87.5%
- Grade 3–5 adverse events: Keytruda 10.3% / Chemotherapy 43.8%
Conclusions
Based on KEYNOTE-122 Phase 3 results, Anthony T.C. Chan et al. concluded that pembrolizumab did not significantly improve overall survival compared to chemotherapy in platinum-pretreated recurrent/metastatic NPC patients. However, the safety profile was more favorable than chemotherapy, with lower adverse event rates within manageable limits.
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