MSD’s Keytruda improvess overall survival in Phase 3 oesophageal cancer

pharmafile | November 15, 2018 | News story | Research and Development Cancer, MSD, PD-L1, keytruda, pharma 

MSD has announced new Phase 3 data on its anti-PD-1 therapy Keytruda (pembrolizumab) as a second-line treatment for advanced or metastatic esophageal or esophagogastric junction carcinoma, demonstrating that the drug hit its primary endpoint in improving overall survival (OS) of patients with PD-L1+ tumours.

In 600 participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the oesophagus, or Siewert type I adenocarcinoma of the oesophagogastric junction for which first-line therapy has proven ineffective, and with a Combined Positive Score ≥10, Keytruda produced “statistically significant improvement” in OS versus chemotherapy alone.

However, despite this, the drug did not achieve statistical significance in OS improvement in patients with squamous cell histology and in the entire intention-to-treat (ITT) study population. MSD also stated that the trial’s secondary endpoints of progression-free survival and objective response rate were not formally tested because of the failure to reach OS in the full ITT population.

“In this pivotal trial, Keytruda resulted in a statistically significant and clinically meaningful improvement over standard chemotherapy in overall survival for patients with advanced oesophageal or oesophagogastric junction carcinoma whose tumours express PD-L1 with a CPS of 10 or greater,” remarked Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, and Chief Medical Officer at MSD. “This marks the sixth tumour type where Keytruda has demonstrated a survival benefit, and represents the first time an anti-PD-1 therapy has achieved overall survival for this patient population.”

“We are encouraged by these results of Keytruda as monotherapy in previously-treated patients, and look forward to continuing our research efforts in this significant area of unmet need with our ongoing Phase 3 trial, KEYNOTE-590, evaluating Keytruda in combination with chemotherapy as a first-line treatment for patients with oesophageal carcinoma.”

Matt Fellows

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