“Immunotherapy is now the standard of care in the recurrent metastatic setting,” said Nabil F. Saba, MD, FACP, Director of Head and Neck Oncology at Emory University and a specialist in immunotherapy for head and neck cancer. “However, we’re still struggling with the question of which immunotherapy and for which patients. Do we use it by itself? Do we use it in combination with chemotherapy?”
Nabil F. Saba, MD, FACP
Dr. Saba commented on the significance of the KEYNOTE-048 data in this setting. However, he also noted the importance of combined therapy with a PD-1 inhibitor and a CTLA-4 inhibitor, as demonstrated in the CheckMate 651 trial.
“The reason this trial is negative is not because of a lack of efficacy of nivolumab and ipilimumab,” he said. “It is likely because the control arm was not really a true EXTREME control, as was the case with KEYNOTE-048, as these two studies accrued patients in different periods of time.” He noted that the CheckMate 651 trial was accruing following the approval of pembrolizumab and nivolumab as second-line agents for patients with recurrent metastatic disease.
“So, many patients on the control arm of the CheckMate 651 trial had access to standard PD-1 inhibitors,” Dr. Saba explained. “At least 40% of these patients received immune checkpoint inhibitors, basically improving their survival and making it so that the difference between the control and experimental arms did not reach statistical significance.”
According to Dr. Saba, one of the most significant questions raised by Dr. Haddad concerns whether nivolumab and ipilimumab might be an accepted regimen for these patients given the responses observed, particularly in patients with a high combined positive score and given the fact that this is happening in a non–chemotherapy-containing regimen.
DISCLOSURE: Dr. Saba has served as an advisor and received compensation from Eisai, Astra Zeneca, Merck, WebMD, OncLive, Mirati, Reach MD, Vaccinex, Kura, Biontech, GSK, Aduro, and Pfizer; and has received research funding from BMS and Exelixis.
