Lung Cancer Drug Extends Survival

Necitumumab added to chemotherapy increases survival to nearly a year.

The addition of an experimental drug to chemotherapy was found to extend survival in stage IV squamous non-small cell lung cancer (NSCLC) to nearly one year during a recent clinical trial.

Reported recently in Lancet Oncology, the phase 3 trial enrolled 1093 NSCLC patients who had necitumumab (IMC-11F8) combined with the chemotherapy drugs gemcitabine and cisplatin. The results showed the addition of necitumumab extended median overall survival to 11.5 months compared with 9.9 months on gemcitabine and cisplatin alone.

"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," co-principal investigator Fred R. Hirsch, MD, PhD, said in a press release.

Necitumumab activates the immune system to fight tumor tissue. Cancers that mutate to over-express epidermal growth factor receptor (EGFR) coat cells that trap more of EGFR, which signals cells to continuously grow and divide.

Immunotherapies that target EGFR direct the immune system to attack cells with an overabundance of EGFR, the study noted.

"As we've seen, this is a very promising approach," Dr. Hirsch said. "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."

Current chimeric monoclonal antibodies are produced using a combination of mouse and human DNA. Drugs based on chimeric monoclonal antibodies create challenges as the antibodies are recognized as threats, which causes the immune system to eliminate them from the body immediately.

Necitumumab utilizes fully human antibodies without hybrid mouse DNA, which can help patients avoid some side effects associated with chimeric antibodies.

"While we saw more side effects in the group treated with necitumumab in combination with the two chemotherapies, we found that the safety profile of necitumumab plus gemcitabine and cisplatin was acceptable and in line with expectations," Hirsch said.