Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial
In this phase 2 trial, researchers from M. Sinai, NY, enrolled a total of 21 patients with resectable HCC to receive two cycles of neoadjuvant cemiplimab 350 mg intravenously every 3 weeks followed by surgical resection. After resection, patients received an additional eight cycles of cemiplimab 350 mg intravenously every 3 weeks in the adjuvant setting. The primary endpoint was significant tumor necrosis on pathological examination, defined as >70% necrosis of the resected tumor. ). 20 patients underwent surgical resection. The majority of patients were Asian and had HBV infection as underlying liver disease. The median time from initiation of treatment and surgical resection was 29 days (IQR 27-35). Three patients (15%) had complete tumor necrosis and 4 (20%) met the primary endpoint of significant necrosis (>70%). There was no case of tumor progression while on treatment. 20/21 patients had adverse events of any grade during neoadjuvant treatment and 7 (33%) had grade 3 adverse events. This trial builds on the evidence of potential for perioperative PD-1-targeted monotherapy in hepatocellular carcinoma. The evaluation of immunotherapy as neoadjuvant therapy for HCC needs further research.
(Thomas, U. M., et al. – Lancet Gastroenterol Hepatol, January 2022)
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