Celeste Lebbé, MD
Invited discussant Celeste Lebbé, MD, of the Hospital Saint Louis in Paris, noted that the study met its primary endpoints and produced “very impressive data”; however, “major toxicity” was a concern.
She said that in this small study of 18 patients (10 for efficacy), several lessons were learned: neoadjuvant therapy using 2 courses of ipilimumab (Yervoy) plus nivolumab (Opdivo) is feasible; the frequency of grade 3/4 adverse events is higher in this setting than in advanced melanoma (42% vs 19%); and this combination can yield “major efficacy,” as shown by the pathologic responses observed in this population.
An effect on recurrence-free survival will be the real test of benefit, and it is far too early for those data. One of the goals of neoadjuvant therapy, she said, is to increase survival by eliminating micrometastatic disease, compared to surgery and standard adjuvant therapy. “There is no clear evidence of this in humans, but promising data in mice,” she said. ■
Disclosure: Dr. Lebbé is on the advisory board for Bristol-Myers Squibb, MSD, Novartis, Roche, and Amgen.