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RFP4. Impact of Keynote-716 on Surgical and Systemic Therapy in Stage IIB and IIC Cutaneous Melanoma

Friday, March 6, 2026
4:38 PM - 4:45 PM MST
Location: 106A-C
Introduction: Immune checkpoint inhibitors (ICIs) have revolutionized treatment of cutaneous melanoma.  The Keynote-716 trial resulted in FDA-approval for adjuvant pembrolizumab in stage IIB and IIC melanoma in December 2021, though the impact of this trial on clinical practice patterns has not been investigated.


Methods: The National Cancer Database Participant Use File 2023 was queried for cutaneous melanoma cases diagnosed between 2019 and 2023.  Patients with clinical stage IIB and IIC melanoma were identified per AJCC 8th Edition criteria.  Cases were divided into a “before” period from 2019-2020 and an “after” period from 2022-2023.  Low-, moderate-, and high-volume centers were stratified.  The primary outcome measure was omission of sentinel lymph node biopsy (SLNB) in the before and after time periods.  Secondary outcome measures were utilization of immunotherapy for patients with pathologic stage IIB or IIC and in those patients who had omission of SLNB.


Results: There were 20,452 patients with clinical stage IIB or IIC melanoma during the study period.  SLNB was performed in 16,850 (82.3%).  Omission of SLNB was comparable in the before and after periods (17.5 vs 17.6%, p=0.970).  Patients treated at low volume centers were more likely to have SLNB omitted compared with moderate- and high-volume centers (21.1% vs 16.9% vs. 15.7%, p< 0.001).  Omission of SLNB was more common with increasing age (≤45 = 3.8%, 45-64 = 7.2%, 65-79 = 14.1%, ≥80 = 39.2%, p< 0.001).  Clinical T stage and overall clinical stage were also predictive of omission of SLNB (T3b = 14.4%, T4a = 19.9%, T4b = 20.4%, p< 0.001; IIB = 16.1%, IIC = 20.5%, p< 0.001).  Adjuvant immunotherapy was delivered in 34.2% in the after period, with the highest rate in 2023 at 38.9%.  For patients in whom SLNB was omitted, receipt of immunotherapy increased from 10.5% to 27.2% across time periods (p < 0.001).  Patients in the after period were more likely to receive immunotherapy if they underwent SLNB (36.5% vs 27.2%, p< 0.001).  In patients with pathologic stage IIB or IIC disease, treatment center designation, facility volume, age, primary payor, community designation, T stage, and overall stage were associated with receipt of adjuvant immunotherapy (Table 1).


Conclusions: The Keynote-716 trial has significantly impacted clinical practice.  While SLNB rates have not been impacted in the initial period following the trial, an increasing number of patients are receiving ICIs whether or not they undergo SLNB.  Future studies should investigate oncologic efficacy and cost-effectiveness of diagnostic and therapeutic options in this population.

Learning Objectives:

  • Understand the clinical implications of Keynote-716 on surgical and systemic therapy
  • Identify demographic, clinical, and institutional factors associated with variation in surgical and systemic management.