FDA Approves Opdivo for Adjuvant Treatment of Esophageal and Gastroesophageal Junction Cancer

Bristol Myers Squibb announced that Opdivo (nivolumab) has been approved by the Food and Drug Administration (FDA) for the adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction cancer who still had residual disease after undergoing neoadjuvant chemoradiotherapy.

“Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types that often require multiple approaches to address the disease including chemotherapy, radiation and surgery,” said Dr. Ronan J. Kelly, director of Baylor Scott and White Charles A. Sammons Cancer Center in Dallas, Texas, in the release. “Even after neoadjuvant (chemoradiotherapy) followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response.”

This FDA approval was based on findings from CheckMate-577, a phase 3 trial in which researchers compared Opdivo (532 patients) with placebo (262 patients) in patients with esophageal or gastroesophageal junction cancer with residual disease after neoadjuvant chemoradiotherapy and complete resection, according to the release. Findings demonstrated that median disease-free survival was greater in patients treated with Opdivo versus those treated with placebo (22.4 months versus 11 months). This was also observed in patients with squamous cell carcinoma (29.7 months versus 11 months) and those with adenocarcinoma (19.4 months versus 11 months).

“In the CheckMate-577 trial, we saw a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients,” Dr. Kelly said. “This is exciting news, providing renewed hope.”

The FDA approval of Opdivo for these patients is a major step from its original treatment approach, which is surveillance in certain instances.

“Esophageal and (gastroesophageal junction) cancer patients with residual pathologic disease following neoadjuvant (chemoradiotherapy) and complete resection face a higher risk of disease recurrence; however, the predominant option for these patients has been surveillance,” said Adam Lenkowsky, senior vice president and general manager of U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb, in a press release. “Today’s news marks an important step for patients as well as meaningful progress toward our commitment to pioneering immunotherapy treatment options in early stages of disease where there is the potential to reduce the risk of recurrence.”

Several precautions and warnings are linked to Opdivo due to severe and fatal immune-mediated side effects including colitis, lung tissue inflammation, a disease affecting the endocrine gland, liver inflammation, liver damage or injury, skin side effects, inflamed nephrons (which are part of the kidneys) and renal dysfunction, infusion-related reactions and other immune-mediated side effects. In addition, Opdivo may cause complications of allogenic hematopoietic stem cell transplantation, according to the release. Patients with multiple myeloma may also have increased mortality when Opdivo is added to dexamethasone and a thalidomide analogue, which is not recommended for patients not currently enrolled in controlled clinical trials.

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