Adding immunotherapy to chemotherapy before surgery for patients with operable non-small cell lung cancer (NSCLC) - the leading cause of cancer deaths worldwide - improved long-term survival overall compared with chemotherapy alone, according to a landmark study published June 2 in the New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology (ASCO), the world's leading professional organization for physicians and oncology professionals caring for patients with cancer.
The research, conducted at the Johns Hopkins Kimmel Cancer Center and led by clinicians at its Bloomberg~Kimmel Institute for Cancer Immunotherapy and international partners, is the first and only phase 3 clinical trial to show a survival advantage for immunotherapy in conjunction with chemotherapy before surgery (neoadjuvant), without additional immunotherapy after surgery.
"Just three doses of immunotherapy and chemotherapy showing a survival advantage is a big step forward for patients," says Julie Brahmer, M.D., director of thoracic oncology at the Kimmel Cancer Center and co-director of the upper aerodigestive program for the Bloomberg~Kimmel Institute for Cancer Immunotherapy.
During the CheckMate-816 clinical trial, 358 patients with stage 1B to 3A resectable NSCLC were randomly assigned to receive standard chemotherapy for three cycles, with or without the anti-PD-1 immunotherapy drug nivolumab, followed by surgery. The initial results from the trial, published in the New England Journal of Medicine in 2022, resulted in Food and Drug Administration approval of the first immunotherapy/chemotherapy combination treatment for patients with operable NSCLC, which is now the standard of care.
The final analysis of the data, presented at the ASCO meeting by principal investigator Patrick Forde, M.B.B.Ch., of Trinity College Dublin, who conducted the research while at the Kimmel Cancer Center, expands on the trial's results with data from patients followed for five years after surgery.
In the immunotherapy plus chemotherapy arm, 24% of patients achieved complete remission - meaning no residual tumor was detected in the lungs or lymph nodes after surgery. For those patients who had complete clearance of their cancers at the time of surgery, five-year survival was 95%.
This work was supported by Bristol Myers Squibb and Ono Pharmaceutical Company Ltd.
