A panel of medical experts advising the Food and Drug Administration recently recommended that the federal agency limit the use of immunotherapies added to chemotherapy for initial treatment of patients with two types of esophago-gastric cancers whose tumors are either metastatic or unresectable.
Instead of endorsing the existing indication for all patients in this category, the Oncologic Drugs Advisory Committee (ODAC) recommended that nivolumab and pembrolizumab be restricted to only those patients with programmed death-ligand 1 (PD-L1) expression of 1% or higher.
Michael Gibson, MD, PhD, associate professor of Medicine and director of Translational Research for Esophagogastric Cancer at Vanderbilt-Ingram Cancer Center voted with the majority on both the decisions. The panel voted to remove the indication for esophageal cancer, and it voted to also remove the indication for gastric/gastroesophageal junction (GEJ) cancer.
“With the accumulation of long-term clinical trial results as well as combined analyses from these studies, we learned that patients with a cps (combined positive score) of less than 1% do not benefit from that addition of immune checkpoint inhibitor to cytotoxic chemotherapy,” said Gibson, who also serves as co-chair of the Vanderbilt-Ingram Scientific Review Committee.
The FDA in 2021 approved nivolumab and pembrolizumab added to chemotherapy for all patients with esophago-gastric cancers that were either metastatic or unresectable. However, clinical data since then demonstrated that the immunotherapies benefited only a subgroup of these patients — those with PD-L1 expression of 1% or higher.
The panel determined that allowing the wider indication would put patients at risk for adverse reactions from the two immunotherapies but without the added benefit in survival.
“Therapeutic immunotherapies are a class of drugs that are widely in use to treat many cancers. However, they may also cause a broad range of immune-related adverse events, some of which may be both severe and irreversible,” Gibson said.
It is uncommon for the FDA to remove a medical indication, but the agency typically follows the recommendations of its expert panels. The Oncologic Drugs Advisory Committee is composed of internationally respected cancer clinicians and researchers. Gibson is an expert on gastrointestinal cancers as well as head and neck cancers.
