Merck Pulls Plug On Two Keytruda Late-Stage Studies On Underwhelming Data

Thursday, Merck & Co Inc MRK provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630.

Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating Keytruda (pembrolizumab) in combination with stereotactic body radiotherapy (SBRT) for stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery.

The decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis.

Also Read: Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer.

At the pre-specified interim analysis, Keytruda, combined with SBRT, did not demonstrate an improvement in event-free survival or overall survival, the study's primary endpoint and key secondary endpoint, respectively, compared to placebo plus SBRT.

The benefit/risk profile of the combination did not support continuing the trial.

Keytruda combined with SBRT was associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo.

Merck is also discontinuing the Phase 3 KEYNOTE-630 trial of Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC.

The DMC recommended stopping the study for futility as the risk/benefit profile did not support continuing the trial.

Data from a pre-planned analysis showed that Keytruda did not cross the boundary for statistical significance in recurrence-free survival (RFS), the study's primary endpoint.

The study's key secondary endpoint, OS, was not formally tested, but at the time of the analysis, the results did not favor Keytruda compared to placebo.

Data analyses for KEYNOTE-867 and KEYNOTE-630 are ongoing, and the results will be shared with the scientific community and regulatory agencies.

Price Action: MRK stock is down 0.27% at $117.70 at the last check on Thursday.

Read Next:

• Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects.

Photo Courtesy of Merck