Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted Priority Review with a PDUFA, or target action, date of September 22, 2017.

“An estimated nearly one-hundred-thousand people are living with gastric cancer in the US, yet little progress has been made in bringing forward new treatment options to these patients for whom chemotherapy has long been the standard of care,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA to bring Keytruda to people with gastric cancer who have progressed after receiving chemotherapy and are in urgent need of another option.”

The application submitted to the FDA is seeking approval for Keytruda monotherapy in previously treated patients at a fixed dose of 200 mg administered intravenously every three weeks. The application is based on data from cohort one of the phase 2 KEYNOTE-059 trial investigating Keytruda in heavily pretreated patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after two or more lines of chemotherapy. Data from cohort one of KEYNOTE-059 will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 2 – 6, 2017 during an oral session on Sunday, June 4 at 9:00 a.m. - 9:12 a.m. CDT (Location: Hall D2).

Merck is committed to investigating new approaches across the spectrum of cancers with more than 500 clinical trials evaluating Keytruda (pembrolizumab) in more than 30 tumor types, including multiple gastrointestinal cancers like gastric cancer. Specific to gastric cancer, Merck’s broad clinical development program encompasses all stages of advanced disease and is investigating Keytruda as monotherapy and in combination with other cancer treatments across multiple lines of therapy. To date, the program includes four gastric cancer registration-enabling studies and numerous other gastrointestinal cancer studies are underway.

Gastric cancer, also called stomach cancer, is a type of cancer that begins in the stomach and tends to develop slowly over many years. Most gastric cancers are adenocarcinomas, which develop from the cells of the innermost lining (mucosa) of the stomach. Risk factors for gastric cancer include gender, age, ethnicity, geography and infection with Helicobacter pylori. Worldwide, gastric cancer is the fifth most common type of cancer and the third leading cause of cancer death. Each year there are approximately 952,000 newly diagnosed cases of gastric cancer resulting in approximately 723,000 deaths worldwide. It is estimated that in 2017, more than 10,000 people will die from gastric cancer in the US alone.

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

Studies of Keytruda – from the largest immuno-oncology program in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The Keytruda clinical programme seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with Keytruda, including the exploration of several different biomarkers across a broad range of tumours.

Keytruda is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. Keytruda for injection is supplied in a 100 mg single-dose vial.