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MSD’s Keytruda boosts overall survival by 31% in advanced oesophageal cancer

pharmafile | January 16, 2019 | News story | Research and Development Cancer, MSD, keytruda, oesophageal cancer, pharma 

MSD has unveiled new Phase 3 data for its blockbuster anti-PD-1 immunotherapy Keytruda (pembrolizumab), showing that the drug succeeded in hitting its primary endpoint of improving overall survival (OS) as a monotherapy in the second-line treatment of of advanced or metastatic esophageal or esophagogastric junction carcinoma.

The company said that the results represented the first time that an anti-PD-1 therapy has shown a survival benefit in this patient population. The data showed that Keytruda reduced the risk of death by 31% compared to paclitaxel, docetaxel or irinotecan chemotherapy in patients with squamous cell carcinoma or adenocarcinoma who progressed after standard therapy and whose tumors expressed PD-L1.

The therapy was also trialled in patients with squamous cell histology and in the entire intention-to-treat (ITT) study population, but it did not achieve statistical significance for OS in these groups.

“The prognosis for patients diagnosed with oesophageal 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,” explained Dr 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 tumours 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.”

MSD’s Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, and Chief Medical Officer, also remarked on the findings: “Oesophageal cancer often progresses aggressively, so we are encouraged to see these overall survival results for Keytruda as monotherapy in previously treated patients. Merck is committed to understanding the clinical benefit of Keytruda across a range of gastrointestinal cancers, including oesophageal cancer. Along with other new data for Keytruda and from our broad oncology portfolio, we are pleased to share our latest clinical research in gastrointestinal cancers at ASCO GI.”

Matt Fellows

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