(Melanoma) Is Pembrolizumab Effective as Neoadjuvant/Adjuvant Therapy?
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Pembrolizumab as Neoadjuvant/Adjuvant Therapy in Malignant Melanoma
On March 2, 2023, Sapna P. Patel and colleagues at the University of Texas M.D. Anderson Cancer Center published in the medical journal The New England Journal of Medicine the efficacy and safety results of a Phase 2 trial evaluating pembrolizumab as neoadjuvant/adjuvant therapy in patients with malignant melanoma.
Trial Design
This Phase 2 trial enrolled 313 patients with high-risk resectable advanced malignant melanoma, randomized to:
- Adjuvant-only group: Pembrolizumab 200 mg every 3 weeks until disease progression or intolerable adverse events, for up to 18 cycles (N=159)
- Neoadjuvant/adjuvant group: Pembrolizumab 200 mg every 3 weeks for 3 cycles before surgery, with surgery within 3 weeks after the 3rd cycle, followed by pembrolizumab 200 mg every 3 weeks within 84 days post-surgery until disease progression or intolerable adverse events, for up to 15 cycles (N=154)
Primary endpoint: event-free survival (EFS). Secondary endpoints: OS, disease control rate, etc.
Efficacy Results
At a median follow-up of 14.7 months:
- 2-year event-free survival rate:
- Adjuvant-only group: 49%
- Neoadjuvant/adjuvant group: 72%
Safety Profile
Grade 3 or higher adverse events:
- Adjuvant-only group: 14%
- Neoadjuvant/adjuvant group: 12%
Conclusions
Based on the Phase 2 trial results, Sapna P. Patel and colleagues concluded that pembrolizumab as neoadjuvant/adjuvant therapy in patients with malignant melanoma significantly improved the 2-year event-free survival rate compared to adjuvant-only therapy, with no new adverse events identified.
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2211437
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