Updated Survival Outcomes From KEYNOTE-716 Support Use of Pembrolizumab in Stage IIB / IIC Melanoma

  • Key Points:
    • In patients with stage IIB / IIC melanoma:
      • Adjuvant pembrolizumab continued to demonstrate significant improvements over placebo in DMFS and RFS:
        • After a median follow-up of 39.4 months
    • Whereas an earlier analysis suggested that there may be a lesser benefit with pembrolizumab in patients with stage IIC disease:
      • This was not observed with additional follow-up
    • The 3-year RFS rates were:
      • 76.2% with pembrolizumab and 63.4% with placebo
    • In patients with stage IIB / IIC melanoma, adjuvant pembrolizumab provides a:
      • 41% reduction in the risk of distant metastasis or death
      • 38% reduction in the risk of recurrence or death:
        • According to an update from the KEYNOTE-716 trial presented at the 2023 ASCO Annual Meeting
  • KEYNOTE-716:
    • Was the first study to demonstrate a benefit for relapse-free survival [RFS] as well as distant metastasis-free survival [DMFS]:
      • Using anti–PD-1 immunotherapy (pembrolizumab) in patients with high-risk, non-nodal, stage IIB / IIC melanoma:
        • This updated analysis support[s] the durability of these findings over time
    • After a median follow-up of 39.4 months:
      • Adjuvant pembrolizumab continued to demonstrate significant improvements over placebo in DMFS (HR 0.59, 95% CI [0.44, 0.79]) and RFS (HR 0.62, 95% CI [0.49, 0.79]), consistent with prior reports
    • The investigators concluded that the results of this analysis support the use of pembrolizumab as adjuvant therapy in patients with resected stage IIB or IIC melanoma:
      • The effect of adjuvant anti–PD-1 antibodies is similar across stages of melanoma from stage IIB through stage IV resected disease
  • Having therapeutic options now validated in this setting is a big step forward for our patients and that the results of this final DMFS analysis confirm the important benefit observed in the previous DMFS report and further consolidate the role of pembrolizumab in this setting
#Arrangoiz #CancerSurgeon #HeadandNeckSurgeon #SurgicalOncologist #Melanoma #SkinCancer #MountSinaiMedicalCenter #MSMC #Miami #Mexico

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