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Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: A single-arm, open-label, phase 2 trial

The Lancet: Gastroenterology & HepatologyMarron TU, Fiel MI, Hamon P, et al. | January 21, 2022


Despite surgical resection of early stage hepatocellular carcinoma, which is a standard clinical practice, most tumors show recurrence, and there is no perioperative intervention exhibiting a survival benefit. Hence, researchers herein evaluated if neoadjuvant cemiplimab (an anti-PD-1) exhibits valuable clinical activity in patients with resectable hepatocellular carcinoma.

  • A single-arm, open-label, phase 2 trial, which is identified to be the largest clinical trial of a neoadjuvant anti-PD-1 monotherapy reported to date in hepatocellular carcinoma.

  • Participants were patients with resectable hepatocellular carcinoma (stage Ib, II, and IIIb) and received two cycles of neoadjuvant cemiplimab 350 mg intravenously every 3 weeks followed by surgical resection.

  • Additional eight cycles of cemiplimab 350 mg intravenously were provided every 3 weeks to patients after resection in the adjuvant setting.

  • A total of 21 patients were enrolled and received neoadjuvant cemiplimab; successful resections were conducted in 20 patients.

  • Significant tumor necrosis was recorded in four (20%) of the 20 patients with resected tumors.

  • A partial response was observed in three (15%) of 20 patients, and stable disease remained maintained in all other patients.

  • A treatment-emergent adverse event of any grade occurred in 20 (95%) patients during the neoadjuvant treatment period.

  • There occurred no grade 4 or 5 events.

  • In this cohort, the observed pathological responses to cemiplimab yield support for the design of larger trials to determine the optimal therapeutic duration and definitively establish the clinical advantage of preoperative PD-1 blockade in patients with hepatocellular carcinoma.