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Merck to Discontinue 2 Phase 3 Trials on Keytruda
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Merck to Discontinue 2 Phase 3 Trials on Keytruda
Aug 29, 2024 4:34 AM

07:10 AM EDT, 08/29/2024 (MT Newswires) -- Merck ( MRK ) said Thursday it is discontinuing two phase 3 trials evaluating Keytruda based on the recommendations of an independent data monitoring committee.

One of the trials is evaluating Keytruda in combination with stereotactic body radiotherapy for the treatment of stage I or II non-small cell lung cancer.

The company said the committee's review of data from a planned interim analysis showed that the combination therapy did not demonstrate an improvement in event-free survival or overall survival, the trial's primary endpoint and a key secondary endpoint. The combination therapy was also associated with higher rates of adverse events.

Meanwhile, the second trial is evaluating Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma.

According to Merck ( MRK ), the independent committee found that Keytruda's risk/benefit profile does not support the trial's continuation. The company said data from a pre-planned analysis showed that the product did not demonstrate statistical significance in the trial's primary endpoint of recurrence-free survival.

Merck ( MRK ) said data analyses for both trials are still ongoing.

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