A collection of recently published news items.

The FDA granted accelerated approval to sacituzumab govitecan (Trodelvy; Immunomedics) for locally advanced or metastatic urothelial cancer based on an objective response rate of 27.7% in the phase II TROPHY trial. The agency also upgraded the agent's accelerated approval to a full approval in locally advanced or metastatic triple-negative breast cancer. In the phase III ASCENT trial, the antibody–drug conjugate extended median progression-free survival by 3.9 months and median overall survival by 5.4 months compared with chemotherapy (N Engl J Med 2021; 384:1529–41).

The agency also authorized the marketing of the artificial intelligence device GI Genius (Cosmo Artificial Intelligence) to assist clinicians in detecting lesions during a colonoscopy. In a prospective trial of patients with adenoma or carcinoma, the device identified lesions in 55.1% of cases, compared with a 42% detection rate for colonoscopy alone.

At the virtual American Association for Cancer Research (AACR) Annual Meeting 2021, researchers reported data from a prospective study on Galleri, GRAIL's multicancer early detection test. Galleri was tested on 2,823 patients with cancer and 1,254 healthy people. The assay had a specificity of 99.5% and a sensitivity of 51.5%. Among patients who tested positive, Galleri determined the tissue of origin in 88.7% of cases.

The 4-1BB (CD137)/HER2 bispecific cinrebafusp alfa (PRS-343; Pieris) may be active in patients with HER2-expressing cancers who have previously received multiple therapies. In a phase I trial presented at the AACR meeting, five of 42 evaluable patients responded to the therapy, and 17 more patients experienced stable disease. The agent increased CD8+ T cells, natural killer cells, and cytotoxic activity in the tumor microenvironment.

Researchers projected that cancer incidence and mortality in the United States will change considerably by 2040 (JAMA Network Open 2021;4:e214708). Notably, melanoma incidence will increase, whereas prostate cancer incidence will drop. Also, there will be more deaths from pancreatic and liver cancers and fewer deaths from breast cancer.

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