FDA Approves Nivolumab for Completed Resected Esophageal, Gastroesophageal Junction Cancer
Median disease-free survival was twice as long in patients who received nivolumab compared to patients who received a placebo.
Officials with the FDA have approved nivolumab (Opdivo) as the first and only immunotherapy indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
“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 Ronan J. Kelly, MD, MBA, director of the Baylor Scott & White Charles A. Sammons Cancer Center, in a press release. “Even after neoadjuvant CRT followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response.”
The approval is based on the results from the phase 3 CheckMate-577 trial, which found that median disease-free survival (mDFS) was twice as long in patients who received nivolumab compared to patients who received a placebo, with mDFS of 22.4 months and 11 months, respectively. Nivolumab also reduced the risk of disease recurrence or death by 31% compared to the placebo, according to a press release.
An exploratory analysis also analyzed results among patients with adenocarcinoma and found that mDFA was 19.4 months among those treated with nivolumab compared to 11.1 months in patients treated with a placebo. Among patients with squamous cell carcinoma, mDFS was 29.7 months in the nivolumab group and 11 months in the placebo group.
“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,” Kelly said in the press release. “This is exciting news, providing renewed hope.”
Nivolumab has several warnings and precautions, including severe and fatal immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when nivolumab is added to a thalidomide analogue and dexamethasone.
The application was reviewed as part of the FDA’s Real-Time Oncology Review pilot program, according to the press release. This program aims to ensure that safe, effective treatments are available as early as possible.
“Esophageal and [gastroesophageal junction] cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection face a high risk of disease recurrence; however, the predominant option for these patients has been surveillance,” said Adam Lenkowsky, senior vice president and general manager of US Cardiovascular, Immunology, and Oncology at Bristol Myers Squibb, in the press release. “Today’s news pioneering immunotherapy treatment options in earlier stages of disease where there is the potential to reduce the risk of recurrence.”
US Food and Drug Administration Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy [news release]. Bristol Myers Squibb; May 20, 2021. https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-as-Adjuvant-Treatment-of-Completely-Resected-Esophageal-or-Gastroesophageal-Junction-Cancer-in-Patients-who-have-Received-Neoadjuvant-Chemoradiotherapy/default.aspx. Accessed May 20, 2021.