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000300307 1001_ $$aLuke, Jason J$$b0
000300307 245__ $$aPembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study.
000300307 260__ $$aAmsterdam [u.a.]$$bElsevier$$c2025
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000300307 520__ $$aAdjuvant pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with resected stage IIB/IIC melanoma in KEYNOTE-716. Results of a post hoc 4-year analysis are reported, including progression/recurrence-free survival 2 (PRFS2).Patients were randomly assigned 1:1 to pembrolizumab 200 mg or placebo intravenously every 3 weeks (part 1). RFS was the primary end point; DMFS was secondary. Patients with recurrence following placebo or 17 cycles of pembrolizumab could cross over to or be rechallenged with pembrolizumab (part 2).Median follow-up (n = 976) was 52.8 months (range, 39.4-64.8). RFS (HR, 0.62 [95 % CI, 0.50-0.78]) and DMFS (HR, 0.59 [0.45-0.77]) favored pembrolizumab. At 48 months, RFS rates were 71.3 % for pembrolizumab and 58.3 % for placebo, and DMFS rates were 81.0 % and 70.1 %, respectively. The HR for PRFS2 was 0.75 (95 % CI, 0.56-1.01); 48-month PRFS2 rates were 82.5 % for pembrolizumab and 76.7 % for placebo. In the crossover population, median follow-up was 36.9 months; median RFS was not reached (NR; 95 % CI, 16.8-NR; 48-month RFS, 50.6 %) in patients with resectable disease (n = 41) and median progression-free survival was 22.0 months (4.5-NR) in patients with unresectable disease (n = 30). Among patients rechallenged, median follow-up was 21.9 months; none with resectable disease had recurrence (n = 6) and 1 with unresectable disease had best response of stable disease (n = 3). No new safety signals were observed.With > 4 years follow-up, pembrolizumab continued to prolong RFS and DMFS and had antitumor activity in patients who crossed over to pembrolizumab.NCT03553836.
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000300307 650_7 $$2Other$$aAdjuvant therapy
000300307 650_7 $$2Other$$aImmune checkpoint inhibitors
000300307 650_7 $$2Other$$aMelanoma
000300307 650_7 $$2Other$$aPembrolizumab
000300307 650_7 $$2Other$$aProgrammed cell death protein 1
000300307 7001_ $$aAscierto, Paolo A$$b1
000300307 7001_ $$aKhattak, Muhammad A$$b2
000300307 7001_ $$aRutkowski, Piotr$$b3
000300307 7001_ $$aDel Vecchio, Michele$$b4
000300307 7001_ $$aSpagnolo, Francesco$$b5
000300307 7001_ $$aMackiewicz, Jacek$$b6
000300307 7001_ $$aMerino, Luis de la Cruz$$b7
000300307 7001_ $$aChiarion-Sileni, Vanna$$b8
000300307 7001_ $$aKirkwood, John M$$b9
000300307 7001_ $$aRobert, Caroline$$b10
000300307 7001_ $$0P:(DE-HGF)0$$aSchadendorf, Dirk$$b11
000300307 7001_ $$ade Galitiis, Federica$$b12
000300307 7001_ $$aCarlino, Matteo S$$b13
000300307 7001_ $$aDummer, Reinhard$$b14
000300307 7001_ $$aMohr, Peter$$b15
000300307 7001_ $$aOdeleye-Ajakaye, Amos$$b16
000300307 7001_ $$aFukunaga-Kalabis, Mizuho$$b17
000300307 7001_ $$aKrepler, Clemens$$b18
000300307 7001_ $$aEggermont, Alexander M M$$b19
000300307 7001_ $$aLong, Georgina V$$b20
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