ASCO-GI 2019—Perioperative immunotherapy found safe in resectable HCC


  • Univadis
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Takeaway

  • In a phase 2 trial, perioperative immunotherapy was safe and led to pathologic complete response (pCR) in 37.5% of patients with resectable hepatocellular carcinoma (HCC), supporting its use as a perioperative treatment in this patient population.

Why this matters

  • In HCC, surgical resection is associated with a high rate of recurrence.
  • There are currently no effective adjuvant or neoadjuvant therapies for HCC.

Study design

  • Randomized, open-label, single-institution phase 2 trial
  • 9 patients received either nivolumab (240 mg every 2 weeks for 6 weeks) or nivolumab + ipilimumab (1 mg/kg every 6 weeks).
  • Patients underwent surgical resection within 4 weeks after last therapy cycle and continued immunotherapy for up to 2 years postresection.
  • Primary endpoints were safety and tolerability.

Key results

  • 5 patients in nivolumab arm and 3 in nivolumab + ipilimumab arm were evaluable.
  • 3 patients (37.5%) achieved pCR (2 in nivolumab arm, 1 in nivolumab + ipilimumab arm).
  • pCR was associated with a significant increase in 2 CD8+ T cell clusters, as well as in Teff/Treg ratio. 
  • Treatment was safe, and did not lead to delays in resection. 

Limitations

  • Pilot trial, still ongoing.

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