Merkel cell carcinoma: neoadjuvant nivolumab shows promising activity

  • Topalian SL & al.
  • J Clin Oncol
  • 23 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant nivolumab is well tolerated, shows response, and improves recurrence-free survival in high-risk patients with resectable Merkel cell carcinoma (MCC).

Why this matters

  • Patients with high-risk MCC relapse within a year after neoadjuvant chemotherapy.
  • Further research of nivolumab in MCC is warranted.

Study design

  • Phase 1/2 CheckMate 358 study.
  • 39 patients with stage IIA-IV MCC received neoadjuvant nivolumab.
  • Funding: Bristol Myers Squibb; ONO Pharmaceutical Company Limited.

Key results

  • 3 patients did not undergo surgery.
  • Median follow-up was 20.3 months.
  • 46.2% of patients had any grade and 7.7% had grade 3/4 toxicities.
  • No treatment-related deaths were reported.
  • 47.2% of patients achieved pathologic complete response, and 15.4% achieved major partial response.
  • No relapses were observed among responders during follow-up.
  • 54.5% of patients had tumor reduction ≥30%.
  • Median relapse-free survival (RFS) was not reached.
    • 24-month RFS rate was 68.5%.
    • 24-month RFS rate was significantly higher in patients with pathologic complete response vs those without:
      • 88.9% vs 52.2%;
      • HR, 0.12 (95% CI, 0.01-0.93).
  • RFS and OS were similar regardless of tumor Merkel cell polyomavirus (P=.394 and .666, respectively) and programmed death-ligand 1 status (P=.998 and .761, respectively).
  • Tumor mutation burden did not differ between patients with or without responses.

Limitations

  • Small study.