SPOTLIGHT During the 12 months spanning this report, August 1, 2022, to July 31, 2023, FDA approved two new ICIs for the first time— tremelimumab (Imjudo) and retifanlimab-dlwr (Zynyz)—and expanded the uses of two of the previously approved ICIs— durvalumab (Imfinzi) and atezolizumab (Tecentriq)—to treat additional types of cancer. In October 2022, tremelimumab (Imjudo) became the tenth ICI to be approved by FDA. It was approved in combination with another ICI, durvalumab (Imfinzi), for treating adult patients with hepatocellular carcinoma (HCC, a type of liver cancer) whose tumor is not removable with surgery. Tremelimumab is the second FDA-approved ICI that targets the checkpoint protein CTLA-4, while durvalumab blocks the checkpoint Going Deep with Immune Checkpoint Inhibitors Immune checkpoint inhibitors (ICIs) are cancer immunotherapeutics that work by releasing certain “brakes” on the surface of immune cells called T cells, which are naturally capable of destroying cancer cells. The first ICI to be approved by the U.S. Food and Drug Administration (FDA) was ipilimumab (Yervoy), in March 2011, for metastatic melanoma. Three-and-a-half years passed before the second ICI was approved, pembrolizumab (Keytruda), also for metastatic melanoma. Since then, nine additional ICIs have been approved by FDA. In addition, FDA has expanded the number of cancer types for which there is at least one ICI approved. The broad utility of these groundbreaking immunotherapeutics is highlighted by the fact that as of July 31, 2023, there was at least one ICI approved for treating 20 cancer types and for treating any type of solid tumor characterized by the presence of specific molecular characteristics. In addition, with many ICIs approved for treating multiple cancer types, there are several diseases for which there is a deep selection of ICIs available as a treatment option. Adapted from (1). FIGURE 19 Hodgkin lymphoma nivolumab and pembrolizumab Non-Hodgkin lymphoma pembrolizumab Lung atezolizumab, durvalumab, cemiplimab-rwlc, nivolumab, pembrolizumab and combination of ipilimumab and nivolumab, tremelimumab and durvalumab Mesothelioma nivolumab and combination of ipilimumab and nivolumab Liver atezolizumab, pembrolizumab and combination of ipilimumab and nivolumab, tremelimumab and durvalumab Gastric pembrolizumab and nivolumab Colorectal nivolumab and combination of ipilimumab and nivolumab Melanoma atezolizumab, ipilimumab, nivolumab, pembrolizumab, relatlimab-rmbw+nivolumab and combination of ipilimumab and nivolumab Merkel cell carcinoma avelumab and pembrolizumab, retifanlimab-dlwr Cutaneous squamous cell carcinoma cemiplimab-rwlc and pembrolizumab Basal cell carcinoma cemiplimab-rwlc Cervical pembrolizumab Endometrial pembrolizumab and dostarlimab-gxly Alveolar soft part sarcoma atezolizumab Kidney avelumab, nivolumab, pembrolizumab, and combination of ipilimumab and nivolumab Bladder atezolizumab, avelumab, nivolumab, and pembrolizumab Bile duct durvalumab Breast pembrolizumab Esophageal nivolumab and pembrolizumab Head & neck nivolumab and pembrolizumab Solid tumors that are microsatellite instability– high or mismatch repair–deficient pembrolizumab, dostarlimab-gxly Solid tumors that are tumor mutational burden-high pembrolizumab FDA-APPROVED AS OF 2023 AACR Cancer Progress Report 2023 Immunotherapy: Pushing the Frontier of Cancer Medicine 106
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