Dr. Cohen on the Design on the SPEARHEAD-2 Trial in Head and Neck Cancer

Ezra Cohen, MD, FRCPSC, FASCO, chief of the Division of Hematology-Oncology, and a medical oncologist at the University of California, San Diego Health, discusses the design of the phase 2 SPEARHEAD-2 trial with ADP-A2M4 plus pembrolizumab (Keytruda) in patients with recurrent or metastatic head and neck cancer.

The design of SPEARHEAD-2 trial was to determine the utility of a PD-1 checkpoint inhibitor and T-cell receptor (TCR) against MAGE-A4, says Cohen. Anti–PD-1 is a mainstay of therapy in recurrent or metastatic head and neck cancer and is now part of the first-line standard of care, according to Cohen; however, the majority of patients will not going to respond to this treatment. With SPEARHEAD-2, investigators attempted to capture that exact patient population who does not respond.

Patients who are doing well on anti–PD-1 alone should continue to receive the treatment, as those patients can do fairly well for a long period of time, Cohen adds. However, for patients who are not responding to anti–PD-1 alone, an additional intervention with an agent such as a TCR against MAGE-A4, might prove effective, says Cohen. At the same time, exposure to anti–PD-1 for 3 cycles would allow time to engineer the cells, ensuring that the new regimen will be ready should a patient not respond to anti–PD-1 treatment, concludes Cohen.