A new study led by researchers at the Johns Hopkins Kimmel Cancer Center and the Bloomberg~Kimmel Institute for Cancer Immunotherapy showed that by adding the immunotherapy drug nivolumab to chemotherapy before surgery (neoadjuvant) for patients with operable non-small cell lung cancer (NSCLC) — the leading cause of cancer deaths worldwide — reduced the risk of recurrence of the cancer or death by more than one-third, according to results from the phase III CheckMate-816 trial. It also achieved a nearly twelvefold increase in pathological complete response — meaning no active cancer remaining when the tumor was removed — over patients who received chemotherapy alone.
The study resulted in Federal Drug Administration (FDA) approval of the first immunotherapy/chemotherapy combination treatment for patients with operable NSCLC. It is the first FDA approval of a neoadjuvant immunotherapy for early-stage NSCLC.
Study findings were reported in the New England Journal of Medicine. The publication coincides with a presentation at the annual meeting of the American Association for Cancer Research Clinical Trials Plenary Session.
“In this trial, we found that the addition of nivolumab to standard neoadjuvant chemotherapy reduced the risk of recurrence of the cancer or death by more than one-third. The treatment was also associated with mostly improved outcomes at surgery, including less extensive surgery, less blood loss and shorter time in the operating room,” says Patrick Forde, M.B.B.Ch., principal investigator of the trial, co-director of the upper aerodigestive cancer division at the Johns Hopkins Kimmel Cancer Center, associate professor of oncology, and associate member of its Bloomberg~Kimmel Institute for Cancer Immunotherapy.
Standard treatment for resectable lung cancer is surgery to remove the tumor, Forde says. Yet most patients experience a lung cancer recurrence after surgery, and when this happens, it usually is incurable. Chemotherapy, using the drugs cisplatin or carboplatin, known as platinum-based chemotherapy, given either before or after surgery, improves patient survival by only 5% at five years, he notes.
“We showed — for the first time — that immunotherapy can really improve outcomes when given with chemotherapy before surgery for newly diagnosed stage 1–3 NSCLC. It reduces the relapse rate by almost 40%, meaning that patients in this study, who would have likely gone on to die of lung cancer, may now be cured,” says Forde.