Journal: Nature cancer
Phase 2 SWOG S1512 (Cohort A) evaluated neoadjuvant pembrolizumab in patients with resectable desmoplastic melanoma.
Study Design
- Design: Single-arm phase 2 trial.
- Population: 28 eligible patients with resectable desmoplastic melanoma.
- Treatment: Pembrolizumab 200 mg IV every 3 weeks for three cycles, followed by surgical excision.
- Tumor assessment: Tumor tissue was assessed pre-treatment, 3–5 weeks after starting therapy, and at surgery.
Primary Endpoint
- Pathologic complete response (pCR) rate by local pathology.
- pCR rate: 71%
- 95% CI: 51–87%
- P < 0.001, meeting the prespecified efficacy endpoint.
Secondary and Other Outcomes
- Clinical response rate and overall survival were evaluated (numerical details not provided in the abstract).
- At 3-year follow-up, 4 patients had died; none of the deaths were attributed to melanoma or treatment-related adverse events.
Safety
- Grade 3 treatment-related adverse events: 2 patients (7%).
- Treatment-related deaths: None reported.
Conclusion
- Neoadjuvant pembrolizumab in resectable desmoplastic melanoma produced a high rate of pathologic complete response with an acceptable safety profile and favorable long-term outcomes in this cohort.