%0 Journal Article
%T Safety of pembrolizumab as adjuvant therapy in a pooled analysis of phase 3 clinical trials of melanoma, non-small cell lung cancer, and renal cell carcinoma.
%A Luke JJ
%A Long GV
%A Robert C
%A Carlino MS
%A Choueiri TK
%A Haas NB
%A O'Brien M
%A Paz-Ares L
%A Peters S
%A Powles T
%A Leiby MA
%A Lin J
%A Zhao Y
%A Krepler C
%A Perini RF
%A Catherine Pietanza M
%A Samkari A
%A Gruber T
%A Ibrahim N
%A Eggermont AMM
%J Eur J Cancer
%V 207
%N 0
%D 2024 Aug 31
%M 38838446
%F 10.002
%R 10.1016/j.ejca.2024.114146
%X <B>BACKGROUND: </B>The safety profile of adjuvant pembrolizumab was evaluated in a pooled analysis of 4 phase 3 clinical trials.<BR><B>METHODS: </B>Patients had completely resected stage IIIA, IIIB, or IIIC melanoma per American Joint Committee on Cancer, 7th edition, criteria (AJCC-7; KEYNOTE-054); stage IIB or IIC melanoma per AJCC-8 (KEYNOTE-716); stage IB, II, or IIIA non-small cell lung cancer per AJCC-7 (PEARLS/KEYNOTE-091); or postnephrectomy/metastasectomy clear cell renal cell carcinoma at increased risk of recurrence (KEYNOTE-564). Patients received adjuvant pembrolizumab 200 mg (2 mg/kg up to 200 mg for pediatric patients) or placebo every 3 weeks for approximately 1 year. Adverse events (AEs) were summarized for patients who received ≥ 1 dose of treatment.<BR><B>RESULTS: </B>Data were pooled from 4125 patients treated with pembrolizumab (n = 2060) or placebo (n = 2065). Median (range) duration of treatment was 11.1 months (0.0-18.9) with pembrolizumab and 11.2 months (0.0-18.1) with placebo. Treatment-related AEs occurred in 78.6 % (1620/2060) of patients in the pembrolizumab group (grade 3-5, 16.3 % [336/2060]) and 58.7 % (1212/2065) in the placebo group (grade 3-5, 3.5 % [72/2065]). Immune-mediated AEs (e.g. adrenal insufficiency, hypophysitis, and thyroiditis) occurred in 36.2 % (746/2060) of patients in the pembrolizumab group (grade 3-5, 8.6 % [177/2060]) and 8.4 % (174/2065) in the placebo group (grade 3-5, 1.1 % [23/2065]). Of patients with ≥ 1 immune-mediated AE or infusion reaction, systemic corticosteroids were required for 35.2 % (268/761) and 20.2 % (39/193) of patients in the pembrolizumab and placebo groups, respectively.<BR><B>CONCLUSIONS: </B>Adjuvant pembrolizumab demonstrated a manageable safety profile that was comparable to prior reports in advanced disease.