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| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Luke, Jason J |b 0 |
| 245 | _ | _ | |a Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study. |
| 260 | _ | _ | |a Amsterdam [u.a.] |c 2025 |b Elsevier |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 520 | _ | _ | |a Adjuvant pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with resected stage IIB/IIC melanoma in KEYNOTE-716. Results of a post hoc 4-year analysis are reported, including progression/recurrence-free survival 2 (PRFS2).Patients were randomly assigned 1:1 to pembrolizumab 200 mg or placebo intravenously every 3 weeks (part 1). RFS was the primary end point; DMFS was secondary. Patients with recurrence following placebo or 17 cycles of pembrolizumab could cross over to or be rechallenged with pembrolizumab (part 2).Median follow-up (n = 976) was 52.8 months (range, 39.4-64.8). RFS (HR, 0.62 [95 % CI, 0.50-0.78]) and DMFS (HR, 0.59 [0.45-0.77]) favored pembrolizumab. At 48 months, RFS rates were 71.3 % for pembrolizumab and 58.3 % for placebo, and DMFS rates were 81.0 % and 70.1 %, respectively. The HR for PRFS2 was 0.75 (95 % CI, 0.56-1.01); 48-month PRFS2 rates were 82.5 % for pembrolizumab and 76.7 % for placebo. In the crossover population, median follow-up was 36.9 months; median RFS was not reached (NR; 95 % CI, 16.8-NR; 48-month RFS, 50.6 %) in patients with resectable disease (n = 41) and median progression-free survival was 22.0 months (4.5-NR) in patients with unresectable disease (n = 30). Among patients rechallenged, median follow-up was 21.9 months; none with resectable disease had recurrence (n = 6) and 1 with unresectable disease had best response of stable disease (n = 3). No new safety signals were observed.With > 4 years follow-up, pembrolizumab continued to prolong RFS and DMFS and had antitumor activity in patients who crossed over to pembrolizumab.NCT03553836. |
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| 650 | _ | 7 | |a Adjuvant therapy |2 Other |
| 650 | _ | 7 | |a Immune checkpoint inhibitors |2 Other |
| 650 | _ | 7 | |a Melanoma |2 Other |
| 650 | _ | 7 | |a Pembrolizumab |2 Other |
| 650 | _ | 7 | |a Programmed cell death protein 1 |2 Other |
| 700 | 1 | _ | |a Ascierto, Paolo A |b 1 |
| 700 | 1 | _ | |a Khattak, Muhammad A |b 2 |
| 700 | 1 | _ | |a Rutkowski, Piotr |b 3 |
| 700 | 1 | _ | |a Del Vecchio, Michele |b 4 |
| 700 | 1 | _ | |a Spagnolo, Francesco |b 5 |
| 700 | 1 | _ | |a Mackiewicz, Jacek |b 6 |
| 700 | 1 | _ | |a Merino, Luis de la Cruz |b 7 |
| 700 | 1 | _ | |a Chiarion-Sileni, Vanna |b 8 |
| 700 | 1 | _ | |a Kirkwood, John M |b 9 |
| 700 | 1 | _ | |a Robert, Caroline |b 10 |
| 700 | 1 | _ | |a Schadendorf, Dirk |0 P:(DE-HGF)0 |b 11 |
| 700 | 1 | _ | |a de Galitiis, Federica |b 12 |
| 700 | 1 | _ | |a Carlino, Matteo S |b 13 |
| 700 | 1 | _ | |a Dummer, Reinhard |b 14 |
| 700 | 1 | _ | |a Mohr, Peter |b 15 |
| 700 | 1 | _ | |a Odeleye-Ajakaye, Amos |b 16 |
| 700 | 1 | _ | |a Fukunaga-Kalabis, Mizuho |b 17 |
| 700 | 1 | _ | |a Krepler, Clemens |b 18 |
| 700 | 1 | _ | |a Eggermont, Alexander M M |b 19 |
| 700 | 1 | _ | |a Long, Georgina V |b 20 |
| 773 | _ | _ | |a 10.1016/j.ejca.2025.115381 |g Vol. 220, p. 115381 - |0 PERI:(DE-600)1468190-0 |p 115381 |t European journal of cancer |v 220 |y 2025 |x 0959-8049 |
| 856 | 4 | _ | |y OpenAccess |u https://inrepo02.dkfz.de/record/300307/files/luke-et-al-2024-pembrolizumab-versus-placebo-as-adjuvant-therapy-in-resected-stage-iib-or-iic-melanoma-final-analysis.pdf |
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