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).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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).

See Also:

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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.