In a new study entitled “Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial” researchers performed a phase 3 clinical trial to test how combining chemotherapy (gemcitabine and cisplatin) with immunotherapy (necitumumab) improves advanced untreated squamous non-small-cell lung cancer patients’ outcomes. The study was published in the journal Lancet Oncology.
Researchers performed a randomized, controlled phase 3 clinical trial (named SQUIRE) to test the therapeutic effect of necitumumab (IMC-11F8) when combined with gemcitabine and cisplatin chemotherapies against untreated stage IV squamous non-small-cell lung cancer. The team enrolled patients from 26 different countries (a total of 1,093 patients), which were then randomly assigned to receive either gemcitabine and cisplatin (control group, n= 548) or the same treatment but combined with necitumumab (n=545).
The team found that patients in the necitumumab group exhibited a significantly longer overall survival when compared to the control group: 11.5 months versus 9.9 months, respectively. Although the adverse effects were higher in the necitumumab group, these were considered acceptable and not unexpected.
The team concluded that in the light of the added benefit, necitumumab is a potential new therapeutical treatment for advanced non-small-cell lung cancer.
Necitumumab is a monoclonal antibody directed against the epidermal growth factor receptor (EGFR). Overexpressing EGFR is a common strategy employed by cancer cells, as it allows these cells to “trap” more epidermal growth factor and proliferate at higher rates. However, these cells become flagged by higher levels of EGFR and are thus distinguishable from the surrounding, normal cells. Directing immunotherapies, such as necitumumab, against EGFR will help the immune system to recognize and destroy cancer cells.
Fred R. Hirsch, MD, PhD, investigator at the University of Colorado Cancer Center, CEO of the International Association for the Study of Lung Cancer, and one of the study’s lead authors noted, “We haven’t seen any new drug approvals in first-line squamous lung cancer in many, many years. I’m very excited to see a new agent that has survival benefit in this space. As we’ve seen, this is a very promising approach, if you discover a protein that is uniquely expressed or over-expressed by a tumor, in this case EGFR, we can use monoclonal antibodies targeting that protein to inhibit the physiological consequences of EGFR activation, which, without therapy, would otherwise lead to cancer progression.”