Clinical Trial Results Published in Nature Medicine Show Immunotherapy’s Potential in Resectable Esophageal and Gastroesophageal Junction Cancers and the Benefits of Monitoring Circulating Tumor DNA (ctDNA) to Measure Disease Response

The results of a study published today in Nature Medicine show exciting immune responses in patients with operable esophageal or gastroesophageal cancers given neoadjuvant immunotherapy. The study results also show the potential for monitoring circulating tumor DNA as a predictor for future intervention.

The article, titled “Neoadjuvant nivolumab or nivolumab plus LAG-3 inhibitor relatlimab in resectable esophageal/gastroesophageal junction cancer: a phase Ib trial and ctDNA analyses” was authored by the clinical trial team led by Ronan Kelly, MD, MBA, Baylor Scott & White Health’s North Texas chief of oncology. Dr. Kelly is the director of oncology at Baylor Scott & White Charles A. Sammons Cancer Center and the W.W. Caruth Jr. Chair of Immunology at Baylor University Medical Center in Dallas.

The Phase 1B two-arm study enrolled 32 patients with operable Stage 2 or 3 cancer of the esophagus or gastroesophageal junction. Participants in Arm A received two cycles of induction nivolumab followed by an additional three cycles of neoadjuvant nivolumab with chemoradiation, followed by surgery. In Arm B, participants received the same regimen as Arm A plus the LAG-3 inhibitor relatlimab.

“The clinical trial met its primary endpoint of safety and showed potential benefit over conventional therapy improving pathologic complete response rate, relapse free and overall survival compared to historical controls,” said Kelly. “We are most excited about the ability to track tumor burden kinetics both pre and post operatively in addition to being able to measure functional anti-tumor immune responses from longitudinal blood samples. This brings a greater precision to the management of our patients in the perioperative setting and will allow us to tailor our approach to an individual moving away from a ‘one size fits all’ approach towards a ‘personalized medicine’ paradigm of care not only in this setting but in many types of cancer.” 

These results contribute to the global body of knowledge about esophageal, gastroesophageal and gastric cancers, which combined are the second leading cause of cancer deaths worldwide. The American Cancer Society estimates that in the United States there will be 22,370 new esophageal cancer cases diagnosed this year and that the lifetime risk of esophageal cancer in the United States is about 1 in 127 in men and about 1 in 434 in women.