The Keytruda trial discontinuations brings MSD’s total axed trials in August to three after it also scrapped its KeyVibe-008 trial citing similar concerns. Image credit: JeanLucIchard via Shutterstock

Merck & Co (MSD) has announced that it is discontinuing two Phase III Keytruda (pembrolizumab) clinical trials.

The KEYNOTE-867 (NCT03924869) trial was evaluating Keytruda plus stereotactic body radiation therapy (SBRT) compared to placebo plus SBRT for the treatment of adult patients with unresected stage I or II non-small cell lung cancer (NSCLC).

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Based on the recommendation of an independent data monitoring committee (DMC), MSD said KEYNOTE-867 was being discontinued because Keytruda in combination with SBRT did not meet the study’s primary endpoint of demonstrating improvement in event-free survival (EFS), or its secondary endpoint of improved overall survival (OS).

MSD’s data revealed that Keytruda in combination with SBRT was associated with higher rates of adverse events (AEs), including those leading to death, in comparison to SBRT and placebo.

The Phase III KEYNOTE-630 trial (NCT03833167) was evaluating Keytruda for the adjuvant treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC).

The DMC recommended axing this trial for ‘futility’ in light of the overall risk/benefit profile of the trial not supporting its continuation. MSD’s preliminary data showed that Keytruda did not cross the statistical significance boundary in the study’s primary endpoint of recurrence-free survival (RFS).

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MSD stated it had informed study investigators and advised study participants to consult with their study team and physician regarding the next steps and treatment options. It added that data analyses for KEYNOTE-867 and KEYNOTE-630 are ongoing and that it would share full results with the scientific community and regulatory agencies in due course.

According to GlobalData’s pharmaceutical database, Keytruda generated global sales of around $25m in 2023, with sales forecast to peak in 2027 at around $34.3m.

GlobalData is the parent company of Clinical Trials Arena.

This month also saw MSD discontinue its Phase III KeyVibe-008 trial (NCT05224141). Designed to evaluate a fixed-dose combination of vibostolimab and Keytruda with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC), pre-planned analysis showed that the primary endpoint of recurrence-free survival (RFS) met the prespecified futility criteria.

Prelude Therapeutics recently entered a partnership with MSD to evaluate its lead candidate, PRT3789, in combination with Keytruda for the treatment of SMARCA4-mutated cancers.