The Food and Drug Administration has approved the drug Keytruda to treat advanced non-small cell lung cancer.
In the largest study published to date using immunotherapy to treat lung cancer, the drug Keytruda (pembrolizumab) was tested on approximately 500 patients with non-small cell lung cancer. Because so many of the patients in the study showed significant long-lasting responses, in October 2014 the FDA granted the drug “breakthrough therapy” status for use in lung cancer, allowing it to be fast-tracked for approval.
“The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated,” said Dr. Edward Garon, the study’s principal investigator and a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “The quality and duration of disease response that was seen in the trial had previously been extremely rare in lung cancer. For people battling this deadly disease, this approach provides real hope of long-lasting responses while avoiding the toxicities of typical chemotherapy.”
The response rate and duration of response for Keytruda were much greater than for drugs traditionally used to treat lung cancer. In the three-year clinical trial, the overall response rate (the percentage of people in whom tumors were substantially reduced in size) was 19 percent. In people who responded to treatment, the average duration of response exceeded one year, a remarkable advance in this difficult disease.