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Lentinula edodes mycelia extract is an orally administered mushroom mycelial extract derived from *Lentinula edodes* and developed as an immunomodulatory biological response modifier for oncology supportive care and adjunctive cancer immunotherapy. Publicly described clinical studies in breast, gastric, and colorectal cancer evaluated daily oral LEM given with cytotoxic chemotherapy, where it was reported to help maintain quality of life, reduce chemotherapy-associated adverse events, and preserve cellular immune function. Preclinical studies also describe enhancement of peptide vaccine antitumor activity through attenuation of regulatory T-cell mediated immunosuppression and promotion of CD8-positive T-cell responses. Its mechanism is not defined as a single receptor-ligand interaction; rather, it appears to act as a complex natural extract that modulates host immunity, including interferon-gamma production, natural killer and T-cell activity, and suppression of regulatory T-cell expansion.
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