Pembrolizumab and all-trans retinoic acid combination treatment of advanced melanoma: long-term survival update
Background: Primary analysis of the phase I/II clinical trial combining pembrolizumab with all-trans retinoic acid (ATRA) for patients with metastatic melanoma showed a median progression-free survival (PFS) of 20.3 months and median overall survival (OS) not reached. Objective: Report 5-year OS and...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2025-06-01
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| Series: | Therapeutic Advances in Medical Oncology |
| Online Access: | https://doi.org/10.1177/17588359251349321 |
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| Summary: | Background: Primary analysis of the phase I/II clinical trial combining pembrolizumab with all-trans retinoic acid (ATRA) for patients with metastatic melanoma showed a median progression-free survival (PFS) of 20.3 months and median overall survival (OS) not reached. Objective: Report 5-year OS and PFS rates. Design: In this single-center, single-arm trial (NCT03200847), 24 anti-PD-1 naïve patients with metastatic melanoma were enrolled between 10/2017 and 07/2020. Methods: The Kaplan–Meier method was used to estimate OS and PFS. Results: At data cutoff (May 14, 2024), all patients had completed treatment, and 58% ( n = 14) remained alive with a median follow-up of 48 months. The updated 5-year OS rate is 54.7% (95% confidence interval (CI): 36.4–82.1), and the 5-year PFS is 36.1% (95% CI: 21.0–62.2), with 33% ( n = 8) having an ongoing complete response. Conclusion: These results underscore the long-term clinical benefit of combining anti-PD-1 with ATRA, with survival rates comparable to anti-PD-1/combinations but with lower toxicity. |
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| ISSN: | 1758-8359 |