Merck Says Keytruda Regimen Fails To Improve Event-Free Survival In Gastric Cancer Patients

Merck & Co Inc MRK announced topline results from the Phase 3 KEYNOTE-585 trial of Keytruda (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment regime.

The Keytruda + chemotherapy regime was followed by adjuvant treatment with Keytruda plus chemotherapy, then Keytruda monotherapy in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma. 

Also Read: Merck's Keytruda Combo Therapy Hits Primary Goal In Patients With Rare Form Of Gastric Cancer.

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, the study met one of its primary endpoints of pathological complete response (pCR) rate. 

It demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone. For the primary endpoint of event-free survival (EFS), there was an improvement in the Keytruda arm; however, the results did not meet statistical significance per the pre-specified statistical analysis plan. 

The overall survival (OS) endpoint was not formally tested since superiority was not reached for EFS. 

Price Action: MRK shares are down 0.80% at $110.20 on the last check Tuesday.