Another new PD-1/L1 drug Durvalumab approved

• by EVOMT
• 2017-06-05

　　The United States Food and Drug Administration (FDA) accelerated the approval of Durvalumab (trade name: Imfinzi) on May 1 local time for the treatment of locally advanced or metastaticfile urothelial cancer patients who develop disease during or after treatment with platinum containing chemotherapy drugs, or within 12 months of receiving neoadjuvant or adjuvant platinum chemotherapy

　　Durvalumab has become another approved immunotherapy for the treatment of urothelial carcinoma following atezolizumab (trade name: Tecentraq) and nivoluumab (trade name: Opdivo)

　　The FDA also approved the Ventana PD-L1 test as a complementary diagnostic test for the determination of programmed cell death ligand 1 (PD-L1) protein in urothelial carcinoma tissue

　　Urothelial carcinoma includes bladder cancer carcinoma, ureter carcinoma and renal pelvis carcinoma, of which bladder cancer carcinoma is the most common

　　The approval of Durvalumab is based on a single arm clinical trial involving 182 patients with locally advanced or metastaticfile urothelial carcinoma who developed disease after receiving platinum containing chemotherapy

　　The objective response rate (ORR) assessed and confirmed by an independent blind review center was 17.0%. The median response duration has not yet been determined

　　The researchers also analyzed the objective response rate based on the expression status of PD-L1. The expression level of PD-L1 was measured using the approved Ventana PD-L1 test. Of the 182 patients, 95 patients with high PD-L1 expression levels had an objective response rate of 26.3%, and 73 patients with low or no PD-L1 expression levels had an objective response rate of 4.1%

　　The most common adverse reactions of Durvalumab (≥ 15% of patients) were fatigue, musculoskeletal pain, constipation, anorexia, nausea, peripheral edema and urinary tract infection. 43% of patients had serious grade 3 to 4 adverse reactions. Infection and immune related adverse reactions included pneumonia, hepatitis, colitis, thyroid disease, adrenal insufficiency and diabetes

　　The recommended dose of Durvalumab is 10 mg/kg, once every two weeks, and given intravenously for more than 60 minutes until the disease progresses or produces toxicity that the patient cannot tolerate