Merck halts two late-stage Keytruda studies in early-stage settings

Merck & Co. announced on Thursday that it is halting two Phase III trials examining the anti-PD-1 therapy Keytruda (pembrolizumab) in earlier treatment stages. The studies involved patients with stage I or II non-small-cell lung cancer (NSCLC) and those with cutaneous squamous cell carcinoma (cSCC). The decision followed interim analyses that did not meet the desired outcomes.

The first study, named KEYNOTE-867, investigated the efficacy of Keytruda combined with stereotactic body radiotherapy (SBRT) in treating approximately 436 patients with stage I or II NSCLC. This group included individuals who were medically unable to undergo surgery or had declined it. During a scheduled interim analysis, it was found that the Keytruda treatment arm did not show improvements in event-free survival or overall survival (OS), which were the trial's main and secondary endpoints, respectively.

Additionally, the combination of Keytruda and SBRT was linked to increased adverse events (AEs), including AEs that resulted in death, compared to the group that received SBRT and a placebo.

The second study, KEYNOTE-630, examined Keytruda as an adjuvant therapy for about 430 high-risk patients with locally advanced cSCC who had undergone surgery and radiation. Following a planned interim analysis, the study's data monitoring committee advised ending the trial due to futility. Keytruda did not meet the statistical significance boundary for recurrence-free survival, the study’s primary endpoint. Although the secondary endpoint of overall survival was not formally examined at the time, the results did not favor Keytruda over the placebo.

Further analyses of both trials are in progress, with results expected to be disclosed at a later date.

This announcement comes shortly after Merck revealed that quarterly sales of Keytruda surpassed $7 billion for the first time. The increasing sales were attributed to the drug's expanding label and its growing use in early-stage therapies. Nevertheless, Merck has faced challenges in advancing Keytruda up the treatment ladder. For instance, in May, the Phase III KEYNOTE-B21 study in newly diagnosed endometrial cancer patients failed to achieve its objectives, marking a rare setback for the drug.

Keytruda has been a significant player in Merck's product lineup, with its wide-ranging approvals and adoption. However, these recent trial discontinuations highlight the complexities and hurdles in clinical drug development, even for a well-established medication. The company remains committed to ongoing analyses and future presentations of the results, aiming to ensure the best possible outcomes for patients across various cancer types.

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