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Soo Park, MD
Soo Park, MD
Posted: Tuesday, November 11, 2025
The Dutch nationwide noninferiority Safe Stop trial showed that, given the high rates of ongoing responses and overall survival after early discontinuation of anti–PD-1 therapy, this approach may be a safe option for patients with metastatic melanoma who achieve a complete or partial response. These findings were presented during the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract LBA61) by Astrid A. van der Veldt, PhD, of Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues.
“Long treatment duration (ie, ≥ 2 years) has significant impact on patients, the potential development of (severe) immune-related adverse events, health-related quality of life, and health-care resources,” the investigators remarked. “Currently, there is no consensus on the optimal treatment duration.” The Safe Stop trial was the first completed prospective study to assess the safety of a shortened duration of anti–PD-1 therapy in patients with metastatic melanoma.
A total of 200 patients from all 14 Dutch melanoma centers who had unresectable stage III or metastatic melanoma and a confirmed complete or partial response were included to stop first-line anti–PD-1 monotherapy. In the event of disease progression, anti–PD-1 therapy could be restarted. Other salvage therapies were allowed at the discretion of the treating physician.
The primary objective was to assess the rate of ongoing responses at 24 months after treatment initiation. This was compared with a 39% ongoing response rate, which was reported for all patients who completed 24 months of treatment in the KEYNOTE-006 trial.
The median duration of anti–PD-1 therapy was 24 weeks. At inclusion in the trial, 58 (29%) patients had a complete response and 10 (5%) had known brain metastases. The investigators reported an ongoing response rate at 24 months of 81.8%. The 24-month overall and melanoma-specific survival rates were 95.9% and 97.4%, respectively.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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