Merck & Co Reports Keytruda Trial Failure in Endometrial Cancer Study
Merck & Co's Phase III KEYNOTE-B21 clinical trial of Keytruda plus chemotherapy in high-risk endometrial cancer patients has failed to meet its primary endpoint of disease-free survival (DFS) improvement. The secondary goal of overall survival (OS) was not tested due to the lack of superiority in DFS. Keytruda's safety profile remains consistent with previous studies, showing no new safety signals. Comprehensive data analysis is currently ongoing. Keytruda already has approvals in the US for certain types of advanced endometrial carcinoma. Merck Research Laboratories remains committed to evaluating Keytruda-based combinations in endometrial and other gynecologic malignancies.
Key Takeaways
- Merck & Co's (MSD) Phase III KEYNOTE-B21 clinical trial of Keytruda plus chemotherapy in high-risk endometrial cancer patients fails to meet the primary endpoint of disease-free survival (DFS) improvement.
- The trial involved 1,095 patients and assessed adjuvant treatment with Keytruda plus chemotherapy, irrespective of radiotherapy status versus adjuvant placebo plus chemotherapy.
- Secondary endpoint of safety was achieved with Keytruda's safety profile in line with prior studies, showing no new safety signals.
- Keytruda has existing approvals in the US for certain advanced endometrial carcinoma types, including combination with Lenvima and monotherapy for MSI-H or mismatch repair deficient patients.
- Merck Research Laboratories will continue to focus on Keytruda's established role in advanced endometrial carcinoma and progress clinical research for Keytruda-based combinations in various gynecologic malignancies.
Analysis
Merck & Co's KEYNOTE-B21 trial failure for Keytruda in high-risk endometrial cancer may impact patients, oncologists, and investors. The financial consequences for Merck are uncertain in the short term, but could limit Keytruda's growth in this indication. Other organizations, such as Roche and AstraZeneca, could benefit if their competing products fill the gap. In the long term, Merck's commitment to Keytruda-based combinations in gynecologic malignancies suggests they will work on new trials to expand Keytruda's role. Patients with endometrial cancer may see alternative treatments emerge as a result. Overall, the market for endometrial cancer treatments remains competitive and dynamic.
Did You Know?
- Phase III KEYNOTE-B21 clinical trial: This is a late-stage clinical trial conducted by Merck & Co to test the safety and efficacy of their drug, Keytruda, in combination with chemotherapy for high-risk endometrial cancer patients.
- Disease-free survival (DFS) improvement: DFS is a measure of the length of time after treatment that a patient survives without any signs or symptoms of cancer.
- Keytruda's safety profile and approvals: Keytruda, also known by its generic name pembrolizumab, is an immunotherapy drug that has already been approved by the US Food and Drug Administration (FDA) for certain types of advanced endometrial carcinoma.