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- W2935746622 abstract "Background: A significant proportion of advanced basal cell carcinomas (BCCs) are incompletely treated with current therapies. As BCCs have particularly high mutational burdens and can express Programmed Death ligand (PDL)-1, we performed a proof-of-concept study of the PD-1 inhibitor, pembrolizumab, for advanced BCCs. Objectives: To assess the clinical effects of pembrolizumab on advanced BCCs. Methods: In this single-institution, two-cohort, non-randomized study (NCT02690948), responses and adverse events (AEs) were assessed in patients who received ≥1 dose of pembrolizumab (200 mg every 3 weeks), with or without vismodegib (150mg daily). Findings: Sixteen eligible patients were enrolled and were evaluable. Overall response rate (ORR) was 38% (6/16) [95% confidence interval (CI): 15-65%], p=0.003, at 18 weeks. ORR for pembrolizumab monotherapy group was 44% (4/9) [95% CI: 14-79%], p=0.008 and pembrolizumab plus vismodegib group was 29% (2/7) [95% CI: 4-71%], p=0.15. Three patients (2 with partial response and 1 with stable disease) continued to receive off-label treatment through their community oncologists and achieved complete response after study discontinuation. One-year progression-free survival probability was 70%, and one-year overall survival probability was 94% for all evaluable subjects. There were no life-threatening AEs or deaths related to study drug. Conclusion: The robust response rate of advanced BCCs to pembrolizumab, together with the acceptable side effect profile, suggests that pembrolizumab has clinical utility against advanced BCCs." @default.
- W2935746622 created "2019-04-25" @default.
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- W2935746622 date "2019-05-01" @default.
- W2935746622 modified "2023-09-26" @default.
- W2935746622 title "533 Pembrolizumab with or without vismodegib for advanced basal cell carcinoma: An investigator-initiated, proof-of-concept study" @default.
- W2935746622 doi "https://doi.org/10.1016/j.jid.2019.03.609" @default.
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