Jan 2022: Pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy plus resection of metastatic lesions.
Efficacy ieu ditaksir di 994 penderita kalawan resiko panengah tinggi atawa luhur kanceuh tina RCC, atawa M1 euweuh bukti geringna, dina KEYNOTE-564 (NCT03142334), a multicenter, randomized (1: 1), ganda-buta, placebo-dikawasa. sidang. Pasén dibéré boh pembrolizumab 200 mg intravenously unggal 3 minggu atawa placebo nepi ka sataun, atawa nepi ka kambuh gering atawa karacunan teu kaampeuh, whichever datang kahiji.
survival bébas kasakit (DFS), dihartikeun salaku periode antara kambuh, metastasis, atawa maot, nya éta ukuran hasilna efektivitas primér. Gemblengna kasalametan mangrupikeun métrik hasil anu sanés (OS). Analisis interim anu prespecified ngungkabkeun paningkatan anu signifikan sacara statistik dina DFS, kalayan 109 (22%) kajadian dina panangan pembrolizumab sareng 151 (30%) kajadian dina panangan plasebo (HR 0.68; 95 persén CI: 0.53, 0.87; p = 0.0010). . Dina panangan henteu, DFS median dicapai. Data OS henteu lengkep dina waktos analisa DFS, kalayan 5% tina populasi maot.
Ngarareunah musculoskeletal, weariness, baruntus, diare, pruritus, sarta hypothyroidism éta épék ngarugikeun paling umum dina percobaan ieu (20 persen).
Pembrolizumab dirumuskeun dina dosis 200 mg unggal tilu minggu atanapi 400 mg unggal genep minggu dugi ka kambuh panyakit, karacunan teu kaampeuh, atanapi dugi ka 12 bulan.
Click here for full prescribing information for Keytruda.
