Nivolumab Approved for Neoadjuvant and Adjuvant Treatment of Non-small Cell Lung Cancer
The immunotherapy is now approved to treat certain lung cancers before and after surgery.
The U.S. Food and Drug Administration (FDA) has approved neoadjuvant nivolumab (Opdivo) with platinum-containing chemotherapy, followed by adjuvant nivolumab alone, for patients with non-small cell lung cancer (NSCLC) that can be surgically removed, is 4 cm or larger or has spread to the lymph nodes, and is not known to harbor mutations in the epidermal growth factor receptor (EGFR) gene or rearrangements involving the anaplastic lymphoma kinase (ALK) gene.
Nivolumab is an immune checkpoint inhibitor, a type of immunotherapy that prevents cancer cells from shutting off a type of antitumor immune response. Nivolumab is approved to treat several types of cancer, including additional indications for NSCLC. Prior to this approval, it had been approved to treat some resectable NSCLC tumors in the neoadjuvant setting; the latest approval allows it to be used in the adjuvant setting as well.
The approval was based on results from the randomized, double-blind, placebo-controlled, multicenter phase III CHECKMATE-77T clinical trial, which enrolled 461 patients with untreated and resectable NSCLC. Patients were randomly assigned (1:1) to receive neoadjuvant chemotherapy with either nivolumab or placebo, followed by adjuvant nivolumab or placebo.
During the first 42 months after starting treatment, patients in the nivolumab arm were 42% less likely than those in the placebo arm to experience a disease event, defined as disease progression before or after surgery, inability to surgically remove the tumor despite an attempt to do so, disease recurrence after surgery, or death. While statistical analyses were not performed on survival rates, nivolumab did not appear to adversely impact the chances of survival at the time of data collection.
The recommended dose for nivolumab is 360 mg every three weeks during neoadjuvant treatment and 480 mg every four weeks during adjuvant treatment. When nivolumab and chemotherapy are administered on the same day, nivolumab should be given first.
NSCLC is the most common type of lung cancer. According to federal statistics, it was estimated that 234,580 individuals would be diagnosed with lung cancer and 125,070 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on October 3, 2024.
