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Keytruda, an immunotherapy agent, demonstrated significant improvement in both distant metastasis-free survival and recurrence-free survival compared to placebo.
Keytruda (pembrolizumab) in the adjuvant setting significantly improved distant metastasis-free survival (time from treatment assignment to first distant metastasis or all-cause death) when compared with a placebo in patients with resected stage 2B or stage 2C melanoma, according to recent study results.
The results — which were presented at the 2022 American Society of Clinical Oncology Annual Meeting — demonstrated that Keytruda had a distant metastasis-free survival rate of 88.1% at 24 months, compared with placebo at 82.2%. The 12-month distant metastasis-free survival also favored Keytruda at 94.7%, compared with 90.2% for placebo.
The study included 976 patients who received either Keytruda (487 patients) or placebo (489 patients) and were stratified by tumor category 3b, 4a and 4b, as well as pediatric status.
Distant metastasis-free survival favored Keytruda across all tumor subcategories. The number of events in the 3b subcategory was 23 in patients receiving Keytruda and 31 in patients receiving placebo, for tumor type 4a it was eight and 20, respectively, and for tumor type 4b it was 30 and 41, respectively. No median distant metastasis-free survival rate was reached; however, the 12-month and 24-month rates favored Keytruda in all of these subgroups.
Fewer distant metastasis events were recorded for the Keytruda group at first recurrence compared with placebo. Forty-five patients (9%) in the Keytruda group and 79 patients (16%) in the placebo group experienced distant metastasis at first recurrence. However, a similar number of patients across both groups experienced distant metastasis events after locoregional occurrence: 18 patients (4%) with Keytruda and 16 patients (3%) with placebo. Most events could be found in the lungs (100 patients) affecting 49% of patients receiving Keytruda vs 73% of patients receiving placebo.
Recurrence-free survival (time from treatment assignment to first recurrence or all-cause death) also favored patients who received Keytruda.
At a median of 37.2 months, patients in the Keytruda group had 95 events (19.5%) vs 139 events (28.4%) events in the placebo group. The 24-month recurrence-free survival rate favored Keytruda (81.2%) vs placebo (72.8%). Similarly, Keytruda had favorable recurrence-free survival rates across all tumor subcategories, and the 24-month recurrence-free survival rates favored Keytruda vs placebo.
Side effects occurred in 83% of patients in the Keytruda group and 64% of patients in the placebo group. Severe or worse side effects occurred in 17% and 5% of patients, respectively. Seventy-seven (16%) patients taking Keytruda discontinued treatment due to side effects.
The side effects reported were typical of this treatment. However, Dr. Georgina V. Long, chair of melanoma medical oncology and transitional research at The University of Sydney, commented during the presentation: “Please note that fatigue in the placebo arm was 19% and 21% in the Keytruda arm, as was pruritis 11% in the placebo arm and 25% in the Keytruda arm.”
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