Cancer immunology is living its Golden Age.1,2 The cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor ipilimumab (Yervoy®) has been approved for the treatment of advanced melanoma by FDA and EMA, and, at a dose of 10 mg/kg, for the adjuvant treatment of stage III melanoma by FDA.3,4 The inhibitors of the programmed cell-death protein 1 (PD-1) nivolumab and/or pembrolizumab have been approved by FDA and/or EMA, or have received a positive CHMP opinion for the treatment of advanced melanoma, advanced non-small cell lung cancer (NSCLC), and metastatic renal cell carcinoma.3,4 The anti-PDL1 inhibitor atezolizumab is under accelerated FDA review for advanced urothelial carcinoma which had disease progression after platinum-based chemotherapy, and prolongs survival in second line NSCLC patients.5,6 Nivolumab prolongs survival as second line treatment in Squamous Cell Carcinoma of the Head and Neck (SCCHN).7 Over 450 trials with atezolizumab, pembrolizumab, or nivolumab are registered at clinicaltrials.gov.8 More than 40 randomized phase III trial are planned or recruiting patients with NSCLC, advanced small cell lung cancer, multiple myeloma, Hodgkin lymphoma, SCCHN, gastric or gastroesophageal junction adenocarcinoma, esophageal carcinoma, hepatocellular carcinoma, urothelial cancer, triple negative breast cancer, colorectal cancer, glioblastoma, and renal cell carcinoma. All these phase III trials are planned to be completed by the end of 2020.8
