Merck & Co – known as MSD outside the US and Canada – has announced that the US Food and Drug Administration (FDA) has approved its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC).

The approval, which represents the sixth gastrointestinal cancer indication for Keytruda-based regimens in the US, means Keytruda can now be used alongside gemcitabine and cisplatin to treat patients with locally advanced unresectable or metastatic BTC.

BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 20,000 people are diagnosed with the disease each year in the US and about 70% of BTC patients are diagnosed at an advanced stage.

The FDA’s approval was supported by results from the late-stage KEYNOTE-966 trial, which demonstrated a significant overall survival benefit in these patients versus chemotherapy alone.

The results showed that the Keytruda regimen reduced the risk of death by 17%, demonstrating a median overall survival of 12.7 months versus 10.9 months for chemotherapy alone.

Dr Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, said: “Many patients with BTC are diagnosed with locally advanced or metastatic disease, at which point they are not eligible for surgery and face poor survival outcomes with limited treatment options.

“With this approval, Merck is proud to offer a new treatment option to certain patients with locally advanced unresectable or metastatic BTC, and their healthcare providers, that has shown an overall survival benefit compared to chemotherapy alone.”

Beyond BTC, Keytruda holds approvals to treat a wide variety of cancers, including specific cases of bladder cancer, melanoma and Hodgkin’s lymphoma.

Last month, the therapy was approved in the US as part of a combination treatment for patients with earlier stages of lung cancer.

The FDA’s decision specifically applies to patients with resectable non-small cell lung cancer and means that Keytruda can now be used in combination with platinum-containing chemotherapy as a neoadjuvant therapy to prepare patients for the surgical removal of their tumour and then as a single agent as an adjuvant treatment after surgery.

https://www.pmlive.com/pharma_news/mercks_keytruda_combination_granted_fda_approval_for_biliary_tract_cancer_1503287