Merck’s Keytruda just keeps on proving its value to the company and patients. The company released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.
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Merck’s Keytruda just keeps on proving its value to the company and patients. The company released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.
The anti-PD-1 checkpoint inhibitor met its primary endpoint, significantly improving overall survival (OS) in patients with squamous cell carcinoma or adenocarcinoma whose disease progressed after standard therapy and whose cancers expressed PD-L1. There was a 31 percent decrease in the risk of death compared to a chemotherapy regimen of paclitaxel, docetaxel or irinotecan.
Merck notes that this is the first time an anti-PD-1 drug has shown a survival benefit in this patient population.
The data are being presented at the 2019 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco on Thursday, Jan. 17.
“The prognosis for patients diagnosed with esophageal cancer is poor, and for those who experience disease progression, there is no established standard of care, underscoring the need for improved therapies in the second-line setting,” stated Takashi Kojima, professor at the Department of Gastroenterology and Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan. “The significant improvement in overall survival observed with Keytruda in patients with squamous cell carcinoma or adenocarcinoma whose tumors expressed PD-L1 with a CPS of 10 or greater represents an important scientific advancement and has the potential to benefit patients who currently have limited treatment options.”
Merck had announced earlier that data from KEYNOTE-181 will be submitted to the U.S. Food and Drug Administration (FDA) and other regulatory agencies for review. It continues to evaluate Keytruda across multiple settings and stages of gastrointestinal cancer, including gastric, hepatocellular carcinoma and esophageal. This clinical program is evaluating more than 9,000 patients in 65 trials involving Keytruda, in addition to 7,000 patients in 35 trials affiliated with Merck. KEYNOTE-590, a Phase III trial, is studying Keytruda in combination with chemotherapy as a first-line therapy in esophageal cancer.
KEYNOTE-181 is looking at Keytruda alone compared to chemotherapy in more than 600 patients with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, or Siewert type I adenocarcinoma of the esophagogastric junction that has progressed after first-line standard therapy. The primary endpoint is overall survival. Secondary endpoints are progression-free survival (PFS), objective response rate (ORR) and safety and tolerability.
Today’s announcement follows a November 2018 announcement that Keytruda had beaten out chemotherapy at adding to the lifespan of some esophageal cancer patients. These results add to that, with the 31 percent reduced risk of death.
It is possible the results will make the drug the first in its class to gain approval. Esophageal cancer is the seventh most common cancer in the world. In the U.S., it is expected to affect 17,650 adults this year. Worldwide, about 572,000 new cases were diagnosed last year.
Keytruda has been approved as a monotherapy in lung cancer, melanoma and bladder cancer, and this data suggests esophageal cancer might be added to that list. However, last week at the JP Morgan Healthcare Conference, Merck’s R&D head, Roger Perlmutter, indicated that the bulk of the drug’s future will be in combinations. “We mounted an effort starting five years ago to explore the full use of the molecule in monotherapy,” he said at the meeting, and “we’re getting to the point where most of that monotherapy work is done.”
