Pembrolizumab Combo Fails to Reach Endpoint in Gastroesophageal Junction Cancer Trial

According to a story from Healio, a phase 3 clinical trial evaluating pembrolizumab plus perioperative chemotherapy as a treatment for locally advanced and resectable gastric adenocarcinoma and gastroesophageal junction cancer failed to achieve the primary endpoint of extended event-free survival (EFS). The specific regimen used in the trial included pembrolizumab (classified as anti-PD-1 therapy) used in combination with neoadjuvant chemotherapy and adjuvant chemotherapy, which was then followed by treatment with pembrolizumab on its own.

About Gastroesophageal Junction Cancer

Gastroesophageal junction (GEJ) cancer is an adenocarcinoma that usually affects the lower third of the esophagus. Among esophageal cancers, this form is the more prevalent type in the developed world. This cancer is more common in men and other risk factors include acid reflux, obesity, and tobacco use. This can be a dangerous type of cancer because symptoms may not appear until the disease has reached an advanced stage, when it is less likely to be responsive to treatment. Symptoms include difficulty swallowing, pain while swallowing, pain in the chest or stomach the resembles heartburn, a hoarse cough, food regurgitation, vomiting (which can include blood), and nausea. Other symptoms may occur if cancer has metastasized to other parts of the body. Treatments for GEJ cancer may include surgery, chemo, and radiation therapy. Unfortunately, outcomes for GEJ cancer are poor; in the US, the five-year survival rate is only 15 percent for esophageal cancer as a whole. Learn more about GEJ cancer over at Patient Worthy’s disease cornerstone page.

About Gastric Adenocarcinoma

Gastric adenocarcinoma is the most common type of stomach cancer. In about 60 percent of stomach cancer cases, infection with the bacteria Helicobacter pylori is responsible for causing the disease. There are also several other risk factors for this cancer, such as smoking, infection with the Epstein-Barr virus or HIV virus, family history, diabetes, obesity, and a diet high in pickled vegetables, processed or smoked meat, red meat, and salt. Men are also more likely to get stomach cancer, which suggests the possibility that estrogen could be protective. Symptoms of gastric adenocarcinoma include heartburn, abdominal pain, appetite loss, fatigue, weakness, bloating, vomiting, weight loss, and jaundice. It often does not cause symptoms in the early stages, so many patients are diagnosed with advanced disease. Treatment for this disease includes surgery, chemotherapy, radiation, and targeted therapies. The five-year survival rate in the US is only 28 percent. Learn more about gastric adenocarcinoma over on Patient Worthy’s disease cornerstone page.

About the Trial

The trial included 1,007 patients who received either the combination regimen or a placebo. Aside from event-free survival, other primary endpoints in the clinical trial included overall survival and rate of complete response. While the data indicated a statistically significant increase in the complete response rate, the increase in EFS in the pembrolizumab group did not achieve statistical significance as defined by the trial parameters.

Read more about the results of this clinical trial over at Healio.


Share this post