Perioperative Opdivo alone, in combination with Yervoy safe in patients with HCC
Nivolumab alone or in combination with ipilimumab was safe and well-tolerated in patients with resectable hepatocellular carcinoma in the perioperative setting, according to a study published in Lancet Gastroenterology and Hepatology.
In a randomized, phase 2 trial, Ahmed O. Kaseb, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, and colleagues sought to examine the safety and efficacy of Opdivo (nivolumab, Bristol-Myers Squibb) with and without Yervoy (ipilimumab, Bristol-Myers Squibb) in patients with resectable HCC.
They enrolled 27 patients (mean age, 64 years; mostly men) between October 2017 and December 2019 and assigned 13 to nivolumab alone (group A) and 14 to nivolumab plus ipilimumab (group B) before and after partial hepatectomy.
Participants in group A received 240 mg of IV nivolumab every two weeks (three doses) before liver resection; four weeks after surgery, this group received 480 mg of IV nivolumab every four weeks up to 2 years. Those in group B received the same regimen as group A, with the addition of IV ipilimumab (1 mg/kg) with preoperative nivolumab; up to four doses of ipilimumab were given every 6 weeks postoperatively to this group.
According to study results, 77% of patients in group A and 86% in group B had treatment-related adverse events of any grade, but “no patients in either group had their surgery delayed due to grade 3 or worse adverse events,” Kaseb and colleagues wrote.
Further, 23% of patients in group A (95% CI, 5-53.8) had an overall partial radiologic response at week 6, before surgery, compared with none from group B (95% CI, 0-23.2). Of 20 patients who had surgery, three of nine patients in group A had a major pathological response vs. three of 11 in group B.
Investigators reported a median progression-free survival of 9.4 months in group A compared with 19.53 months in group B.
“Our findings provide the first evidence that neoadjuvant immune checkpoint therapy is safe in patients with resectable hepatocellular carcinoma,” Kaseb and colleagues concluded. “Preliminary activity results suggest that patients treated with neoadjuvant immune checkpoint therapy can achieve a major pathological response with longer recurrence-free survival. Combination therapy with nivolumab plus ipilimumab warrants further studies in the preoperative setting for patients with resectable hepatocellular carcinoma, which could transform the role of immunotherapy from palliative treatment in the metastatic setting to curative treatment in localized disease.”
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