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Bending the Curve Trial by Trial
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SWOG S1801

Neoadjuvant-adjuvant versus adjuvant-only pembrolizumab in resectable stage IIIB to IVC melanoma

Phase 2N = 313NCT03698019

Population
Patients with clinically detectable, measurable stage IIIB to IVC melanoma (cutaneous, acral or mucosal; AJCC 8th edition stage IIIB-IIID or oligometastatic resectable stage IV) amenable to surgical resection
Design
Randomised, open-label phase 2 trial. Neoadjuvant-adjuvant group: three doses of pembrolizumab, surgery, then 15 doses of adjuvant pembrolizumab. Adjuvant-only group: surgery then pembrolizumab 200 mg every 3 weeks for a total of 18 doses (about 1 year). Primary endpoint event-free survival in the ITT population.
Primary endpoint
EFS
Arms
  • Neoadjuvant-adjuvant pembrolizumab (experimental, n = 154): Three doses of neoadjuvant pembrolizumab, surgery, then 15 doses of adjuvant pembrolizumab
  • Adjuvant-only pembrolizumab (control, n = 159): Surgery then pembrolizumab 200 mg every 3 weeks, 18 doses in total
People
Patel SP, senior author Ribas A, SWOG
Δ 24-month EFS+23 points
Show the numbers
Results reported for SWOG S1801
EndpointAnalysisNeoadjuvant-adjuvant pembrolizumabAdjuvant-only pembrolizumabEffect
EFSProgression or toxic effects that precluded surgery, inability to resect all gross disease, events that precluded starting adjuvant therapy within 84 days after surgery, recurrence after surgery, or death from any cause (paraphrased from the abstract).primarymedian follow-up 14.7 monthsPatel 202372% at 2 y (64–80%)49% at 2 y (41–59%)P=0.004P value from the log-rank test comparing event-free survival between groups; the abstract gives no hazard ratio. The 2-year rates come from a landmark analysis. Grade 3 or higher treatment-related adverse events during therapy 12% vs 14%.
Results reported for SWOG S1801
EndpointAnalysisNeoadjuvant-adjuvant pembrolizumabAdjuvant-only pembrolizumabEffect
EFSProgression or toxic effects that precluded surgery, inability to resect all gross disease, events that precluded starting adjuvant therapy within 84 days after surgery, recurrence after surgery, or death from any cause (paraphrased from the abstract).primarymedian follow-up 14.7 monthsPatel 202372% at 2 y (64–80%)49% at 2 y (41–59%)P=0.004P value from the log-rank test comparing event-free survival between groups; the abstract gives no hazard ratio. The 2-year rates come from a landmark analysis. Grade 3 or higher treatment-related adverse events during therapy 12% vs 14%.
Primary publication: Patel SP, Othus M, Chen Y, Wright GP Jr, Yost KJ, Hyngstrom JR, et al. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med. 2023;388(9):813-823. PubMedDOI

Appears in

Sources

  1. Patel SP, Othus M, Chen Y, Wright GP Jr, Yost KJ, Hyngstrom JR, et al. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med. 2023;388(9):813-823.

    PubMedDOI