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KEYNOTE-716

Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma

Phase 3N = 976NCT03553836

Population
Patients aged 12 years or older with newly diagnosed, completely resected stage IIB or IIC melanoma (T3b or T4 with a negative sentinel lymph node biopsy)
Design
Double-blind, randomised (1:1), placebo-controlled phase 3 trial. Pembrolizumab 200 mg (2 mg/kg in paediatric patients) or placebo every 3 weeks for 17 cycles or until recurrence or unacceptable toxicity. Primary endpoint investigator-assessed recurrence-free survival in the ITT population, tested at two planned interim analyses.
Primary endpoint
RFS
Arms
  • Pembrolizumab (experimental, n = 487): Pembrolizumab 200 mg every 3 weeks (2 mg/kg in paediatric patients), 17 cycles
  • Placebo (control, n = 489): Placebo every 3 weeks, 17 cycles
People
Luke JJ, senior author Eggermont AMM
RFSHR 0.65 (95% CI 0.46–0.92)RFSHR 0.61 (95% CI 0.45–0.82)
Show the numbers
Results reported for KEYNOTE-716
EndpointAnalysisPembrolizumabPlaceboEffect
RFSinterimmedian follow-up 14.4 monthsLuke 2022——HR 0.65 (95% CI 0.46–0.92)P=0.0066Median follow-up 14.4 months in the pembrolizumab group and 14.3 months in the placebo group. First recurrence or death in 54 (11%) of 487 vs 82 (17%) of 489. Median RFS not reached in either group. Grade 3 to 4 treatment-related adverse events 16% (78 of 483) vs 4% (21 of 486).
RFSinterimmedian follow-up 20.9 monthsLuke 2022——HR 0.61 (95% CI 0.45–0.82)Median follow-up 20.9 months in both groups. First recurrence or death in 72 (15%) vs 115 (24%). Median RFS not reached in either group.
Results reported for KEYNOTE-716
EndpointAnalysisPembrolizumabPlaceboEffect
RFSinterimmedian follow-up 14.4 monthsLuke 2022——HR 0.65 (95% CI 0.46–0.92)P=0.0066Median follow-up 14.4 months in the pembrolizumab group and 14.3 months in the placebo group. First recurrence or death in 54 (11%) of 487 vs 82 (17%) of 489. Median RFS not reached in either group. Grade 3 to 4 treatment-related adverse events 16% (78 of 483) vs 4% (21 of 486).
RFSinterimmedian follow-up 20.9 monthsLuke 2022——HR 0.61 (95% CI 0.45–0.82)Median follow-up 20.9 months in both groups. First recurrence or death in 72 (15%) vs 115 (24%). Median RFS not reached in either group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFSRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.650.46–0.92
RFS0.610.45–0.82
Primary publication: Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, et al. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022;399(10336):1718-1729. PubMedDOI

Appears in

Sources

  1. Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, et al. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022;399(10336):1718-1729.

    PubMedDOI