For patients who were given a diagnosis of advanced, inoperable (unresectable) biliary tract cancer, an article appeared in Healio with some encouraging news.
Gemcitabine and cisplatin drugs have been the standard of care for advanced biliary tract cancer (BTC) over the past ten years. However, results of the Phase III TOPAZ 1 study (NCT03875235), found that adding a PD1 inhibitor, durvalumab (Infinzi-Astra Zeneca), to gemcitabine and cisplatin brought improved responses. PDL-1 has been found in 72.2% of patients diagnosed with biliary tract cancers.
PD-1 and PDL-1 inhibitors are anticancer drugs that block PD-1 and PDL-1 proteins found on the surface of cells. PDL-1 has been found in 72.2% of patients diagnosed with biliary tract cancers.
According to a report from the National Cancer Institute, the results of TOPAZ offer a “glimmer of hope”.
About Bile Duct Cancers
Bile duct cancers are mostly cholangiocarcinoma, a form of adenocarcinoma. The cancer forms in the bile ducts that transport the digestive bile. These ducts connect the liver to the gallbladder and also the small intestine. The exact cause of the disease is as yet unknown.
Professor Robin Kelley of the Helen Diller Cancer Center explained that cisplatin and gemcitabine promote a low immune reaction when directed against cancer cells. Therefore, it follows that the PD-1 inhibitor pembrolizumab would be added to the standard chemotherapy combination for improved response.
Significant and Meaningful Survival
Additional reinforcement came from KEYNOTE 966, a Phase III study adding another immune checkpoint inhibitor, pembrolizumab, to the standard combination of gemcitabine and cisplatin.
The study was conducted at 175 medical centers around the globe with 1,069 enrolled patients. KEYNOTE 966 reported clinically meaningful and statistically significant benefits for BTC patients.
The adverse events of grade three to grade five were similar. The pembrolizumab regimen was 85.3% while the combination-only placebo regimen was 84.1%.
The following adverse events were reported: fatigue, constipation, nausea, abdominal pain, rash, fever, and decreased appetite. Professor Kelley noted that adding pembrolizumab did not change the previously reported toxicity percentages.
A new standard of care has been established with pembrolizumab added to chemotherapy for advanced BTC. Additional work is needed to identify biomarkers and other groups that most likely will benefit from the treatment.