Pembrolizumab

In a multinational double-blind trial (KEYNOTE-716 [NCT03553836]), patients with completely resected stage IIB or stage IIC melanoma were randomly assigned (1:1) to receive either pembrolizumab or placebo. The primary end point was RFS, defined as the time from randomization until the date of first recurrence or death from any cause. If recurrence was documented, patients could cross over or repeat treatment with pembrolizumab. The secondary end point was DMFS. Pembrolizumab was given as an intravenous infusion of 200 mg every 3 weeks, for a total of 17 doses (approximately 1 year).A total of 976 patients were randomly assigned: 487 to pembrolizumab and 489 to placebo. Baseline characteristics were balanced, including the number of patients with ulcerated tumors (40% of stage IIB; 36% of stage IIC) in both arms.[17]

In a multinational double-blind trial (KEYNOTE-716 [NCT03553836]), patients with completely resected stage IIB or stage IIC melanoma were randomly assigned (1:1) to receive either pembrolizumab or placebo. The primary end point was RFS, defined as the time from randomization until the date of first recurrence or death from any cause. If recurrence was documented, patients could cross over or repeat treatment with pembrolizumab. The secondary end point was DMFS. Pembrolizumab was given as an intravenous infusion of 200 mg every 3 weeks, for a total of 17 doses (approximately 1 year).A total of 976 patients were randomly assigned: 487 to pembrolizumab and 489 to placebo. Baseline characteristics were balanced, including the number of patients with ulcerated tumors (40% of stage IIB; 36% of stage IIC) in both arms.[17]

At the first interim analysis with a median follow-up of 14.4 months, the 12-month RFS rate was 90.0% (95% CI, 87%–93%) in the pembrolizumab group and 83% (95% CI, 79%–86%) in the placebo group.[17][Level of evidence B1]

In a multinational double-blind trial (KEYNOTE-716 [NCT03553836]), patients with completely resected stage IIB or stage IIC melanoma were randomly assigned (1:1) to receive either pembrolizumab or placebo. The primary end point was RFS, defined as the time from randomization until the date of first recurrence or death from any cause. If recurrence was documented, patients could cross over or repeat treatment with pembrolizumab. The secondary end point was DMFS. Pembrolizumab was given as an intravenous infusion of 200 mg every 3 weeks, for a total of 17 doses (approximately 1 year).A total of 976 patients were randomly assigned: 487 to pembrolizumab and 489 to placebo. Baseline characteristics were balanced, including the number of patients with ulcerated tumors (40% of stage IIB; 36% of stage IIC) in both arms.[17]

At the second interim analysis with a median follow-up of 20.9 months, the 18-month RFS rate was 86% (95% CI, 82%–89%) in the pembrolizumab group and 77% (95% CI, 73%–81%) in the placebo group.

In a multinational double-blind trial (KEYNOTE-716 [NCT03553836]), patients with completely resected stage IIB or stage IIC melanoma were randomly assigned (1:1) to receive either pembrolizumab or placebo. The primary end point was RFS, defined as the time from randomization until the date of first recurrence or death from any cause. If recurrence was documented, patients could cross over or repeat treatment with pembrolizumab. The secondary end point was DMFS. Pembrolizumab was given as an intravenous infusion of 200 mg every 3 weeks, for a total of 17 doses (approximately 1 year).A total of 976 patients were randomly assigned: 487 to pembrolizumab and 489 to placebo. Baseline characteristics were balanced, including the number of patients with ulcerated tumors (40% of stage IIB; 36% of stage IIC) in both arms.[17]

At a median follow-up of 39.4 months, the 36-month RFS rate was 76.2% in the pembrolizumab group and 63.4% in the placebo group. An updated analysis of DMFS reported a 36-month DMFS rate of 84.4% in the pembrolizumab group and 74.7% in the placebo group. Median DMFS was not reached in either group.[18,19]