Necitumumab in Squamous NSCLC

H. Jack West, MD: There was a trial called SQUIRE that looked at a combination of cisplatin and gemcitabine with or without necitumumab, which is an anti-EGFR monoclonal antibody. This demonstrated a modest but statistically significant overall survival benefit in this challenging population with advanced squamous non—small cell lung cancer, where we really haven’t had a targeted therapy available, certainly in the first-line setting. This trial has led to the FDA approval of necitumumab.

Its use in the clinic has been limited. I think that’s just been due to a question of what we might perceive as statistical significance versus clinical significance when you’re talking about an improvement in median overall survival of less than a couple of months, adding some potential toxicities such as rash and diarrhea that can accompany anti-EGFR agents. And so, it is an option, though I don’t think it is going to be a widely practiced one. Certainly, history up until now has demonstrated that it has not been widely adopted.

It’s going to be challenging as we see more options emerge in the first-line setting for patients with squamous non—small cell lung cancer—particularly several positive trials for chemotherapy in combination with immunotherapy in the first-line setting, or immunotherapy as monotherapy for the subset of patients with historically high PD-L1 expression, and even just a 1% cutoff, as was demonstrated in a positive trial, KEYNOTE-042. So, it’s an option, though I think it’s going to be a challenged option that, historically, has not been widely used.