Too Much Treatment
By comparing pembrolizumab with placebo, KEYNOTE-054 may also be able to give insight into whether some patients with resected stage III disease may be able to forego adjuvant therapy altogether, Dr Gastman said. In the study, if a recurrence occurred, patients were eligible for crossover or to repeat treatment with pembrolizumab.
“When giving adjuvant treatment we are treating patients that will recur, but we are also treating patients that will not recur,” Dr Gastman said. “It may be that waiting until disease recurs and then treating the right people will result in the same benefit, though by waiting we will be treating patients with a much bigger disease burden.”
Dr Gastman said the KEYNOTE-054 RFS results will likely be enough to drive FDA approval of pembrolizumab in the adjuvant setting.
Yet when it comes to whether nivolumab is superior to pembrolizumab, he noted that the 2 drugs are “very similar.” One possible advantage to pembrolizumab is the every 3 weeks treatment schedule compared with the every 2-week schedule of nivolumab.
“I think a lot of patients might shift to this because it is an easier schedule for them,” Dr Gustman said.
- Eggermont AMM, Blank CU, Mandala M, et al. Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: efficacy and safety results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial. Oral presentation at: 2018 American Association for Cancer Research Annual Meeting; April 14-18, 2018; Chicago, IL.
- Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018 Apr 15. doi: 10.1056/NEJMoa1802357 [Epub ahead of print]
- Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377(19):1824-35. doi: 10.1056/NEJMoa1709030
- Grossmann KF, Othus M, Tarhini AA, et al. SWOG S1404: a phase III randomized trial comparing standard of care adjuvant therapy to pembrolizumab in patients with high risk resected melanoma. J Clin Oncol. 2016;34(suppl.) doi: 10.1200/JCO.2016.34.15_suppl.e21032