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Axalimogene filolisbac + mitomycin + 5-fluorouracil is a combination chemo-immunotherapy regimen evaluated for the treatment of locally advanced anal cancer. The primary component, axalimogene filolisbac (ADXS11-001), is a live-attenuated *Listeria monocytogenes* immunotherapy bioengineered to secrete a tLLO-HPV-E7 fusion protein. This protein targets the HPV-16 E7 oncoprotein, which is expressed in nearly all anal cancers, to stimulate a robust CD4+ and CD8+ T-cell response against tumor cells. The regimen includes the standard-of-care chemotherapeutic agents mitomycin (a DNA cross-linking agent) and 5-fluorouracil (a thymidylate synthase inhibitor), typically administered in conjunction with intensity-modulated radiation therapy (IMRT). This specific combination was the focus of the BrUOG 276 Phase I/II clinical trial led by Brown University.
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