Also known as cholangiocarcinoma, biliary tract cancer can be incredibly aggressive. Further, this cancer is often diagnosed in later stages, making it more difficult to treat. The 5-year survival rate currently sits at around 9-11%. As a result, identifying novel therapeutics and interventions is crucial to improving outcomes and reducing the burden on patients. According to a November 2023 news release from Merck, the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) in conjunction with chemotherapy (gemcitabine and cisplatin) for people living with locally advanced unresectable or metastatic biliary tract cancer. Unresectable means that the tumor cannot be removed surgically; metastatic means that it has spread.
Keytruda is a humanized antibody used in cancer immunotherapy to treat a wide variety of cancers. This anti-PD1 therapy, administered via injection, works by amplifying the immune system’s ability to identify and attack tumor cells. Learn more about Keytruda.
The most recent approval hinged on data from the Phase 3 KEYNOTE-966 study. 1,069 participants enrolled. Participants received either Keytruda plus gemcitabine and cisplatin, or a placebo and gemcitabine and cisplatin, under toxicity or disease progression. The study found that:
- Keytruda plus chemotherapy improved overall survival rates and reduced the mortality risk by 17%.
- Median overall survival for the combination therapy was 12.7 months compared to just chemotherapy (10.9 months) – i.e. Keytruda added approximately 1.8 months to the overall survival.
- Keytruda reduced the risk of disease progression by 14%. Median progression-free survival was 6.5 months, compared to 5.6 months with just chemotherapy.
- 15% of participants discontinued treatment due to Keytruda side effects, with pneumonitis being the most common side effect related to discontinuation.
Merck offers a reimbursement program for Keytruda, as well as a Patient Support program. You can learn more about these programs by calling 855-257-3932 or 855-398-7832 respectively.
The Details: Keytruda
Outside of biliary tract cancer, Keytruda is also approved for use in recurrent, metastatic, or locally advanced cutaneous squamous cell carcinoma; high-risk early-stage, locally recurrent unresectable, or metastatic triple-negative breast cancer; MSI-H or dMMR advanced endometrial carcinoma; unresectable or metastatic tumor mutational burden-high solid tumors; renal cell carcinoma; Merkel cell carcinoma; hepatocellular carcinoma; esophageal cancer; gastric cancer; cervical cancer; microsatellite instability-high or mismatch repair deficient colorectal cancer; locally advanced or metastatic urothelial carcinoma; unresectable or metastatic melanoma; primary mediastinal large B-cell lymphoma; relapsed or refractory Hodgkin’s lymphoma; head and neck squamous cell cancer; and non-small cell lung cancer.
Keytruda has been evaluated in a large number of clinical studies. While relatively safe and well-tolerated, some adverse reactions have been linked to Keytruda use. These include, but are not limited to:
- Immune-mediated pneumonitis, colitis, hepatitis, thyroid disorders (thyroiditis, hyper- or hypothyroidism), endocrinopathies (adrenal insufficiency, hypophysitis), type 1 diabetes, nephritis, dermatitis (toxic epidermal necrolysis, Stevens-Johnson syndrome), myocarditis, or encephalitis
- Anemia (low red blood cell count), thrombocytopenia (low platelet count), and neutropenia (low white blood cell count)
- Fever and fatigue
- Infusion-site reactions such as hypersensitivity or anaphylaxis
- Nausea and vomiting
- Alopecia
- Polyneuropathy
- Diarrhea or constipation
- Appetite loss
About Biliary Tract Cancer
Biliary tract cancer is a rare cancer that manifests in the tubes that carry bile from the liver to the small intestine. It may be considered intrahepatic (forming in the bile ducts inside the liver) or extrahepatic (forming in the bile ducts outside the liver). Extrahepatic biliary tract cancer may also be broken down into perihilar or ductal. Doctors don’t know the exact cause of biliary tract cancer. However, risk factors have been identified. These include biliary cysts, being older in age, having a history of bile duct inflammation, being obese, having diabetes, or having been exposed to Thorotrast. Symptoms related to this cancer may include jaundice (yellowing of the skin, eyes, and mucous membranes); pale stools and dark urine; right abdominal pain; fever and chills; itchy skin; nausea and vomiting; appetite and weight loss; and general weakness.
