Opdivo (nivolumab) significantly prolongs the time patients with resected esophageal or gastroesophageal junction (GEJ) cancer live without signs of disease after receiving chemoradiation therapy followed by cancer removal surgery, interim data from a Phase 3 trial show.
Consistent with data from previous studies, Opdivo demonstrated a favorable safety profile in this setting.
This is the second cancer, after melanoma, in which Opdivo demonstrated benefits as an adjuvant therapy — a treatment given after surgery to prevent cancer from returning.
Opdivo is also the first and only therapy that effectively extended disease-free survival in esophageal or GEJ cancer patients who first received neoadjuvant chemoradiation therapy followed by surgery. Neoadjuvant treatments aim to shrink a tumor before surgery.
“Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner,” Ronan J. Kelly, MD, director of the Charles A. Sammons Cancer Center at Baylor University Medical Center, said in a press release.
“For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients,” Kelly added.
Opdivo is an immune checkpoint inhibitor developed and marketed by Bristol Myers Squibb. It works by blocking the activity of PD-1 — a protein found on the surface of immune T-cells — that is often hijacked by cancer cells to avoid being targeted and destroyed by these immune cells.
By blocking PD-1, Opdivo increases T-cells’ ability to recognize and eliminate malignant cancer cells.
Opdivo has been approved, both alone and in combination with other immune checkpoint inhibitors, for the treatment of different types of cancer, including melanoma, lung, kidney, liver, and esophageal cancer.
The CheckMate-577 Phase 3 trial (NCT02743494) is investigating Opdivo as an adjuvant treatment for esophageal or GEJ cancer patients who previously received neoadjuvant chemoradiation therapy and failed to achieve a pathological complete response — tissue samples collected after surgery still showed some signs of cancer.
The main goal is to determine whether Opdivo is better than a placebo at extending the time patients live without signs of disease. Overall survival will also be assessed as a secondary objective.
After undergoing chemoradiation therapy and surgery, participants were randomly assigned to either 240 mg of Opdivo or a placebo, given as intravenous infusions every two weeks for a period of 16 weeks. After this initial period, Opdivo was administered every four weeks at a dose of 480 mg, until disease progression or unacceptable toxicity.
Interim data from CheckMate-577 showed the study met its primary goal, meaning that Opdivo was superior to a placebo at prolonging disease-free survival when used in an adjuvant setting in these patients. Its safety profile was consistent with prior studies.
“The results from CheckMate -577 are immensely important for physicians and patients, and have the potential to establish Opdivo as a new standard of care,” said Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol Myers Squibb. “We plan to provide our data to health authorities worldwide with the goal of bringing Opdivo as an adjuvant therapy to these patients with high unmet need.”
The company is working closely with trial investigators to finish analyzing data that will be presented at an upcoming medical meeting. CheckMate-577 will continue as planned, so that future analyses on overall survival can be made.
