May 13, 2024
Merck Halts Combined Treatment of Keytruda plus vibostolimab Trial for Melanoma
Merck has issued an update regarding the Phase 3 KeyVibe-010 trial, which assesses a combined form of vibostolimab and pembrolizumab as supplementary therapy for patients who have undergone surgery for high-risk melanoma.
The pharmaceutical company has decided to halt the section of the trial involving the combined form of vibostolimab and pembrolizumab. This trial aims to compare the effectiveness of the combined form, which consists of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (branded as Keytruda), with the sole use of KEYTRUDA as supplementary treatment for patients who have undergone surgery for high-risk melanoma (Stage IIB-IV).
During a planned analysis, it was found that the main goal of the trial, which is the time until recurrence of cancer (known as recurrence-free survival or RFS), did not meet the predetermined criteria for potential effectiveness. Additionally, a higher number of patients in the combined treatment group discontinued all supplementary treatments compared to those in the KEYTRUDA-only group, primarily due to immune-related adverse events. This made it highly improbable that the trial would show a significant improvement in RFS.
Following the advice of an independent Data Monitoring Committee (DMC), Merck has decided to reveal which treatment each participant received and recommends that those who were receiving the combined treatment be offered the option to switch to KEYTRUDA monotherapy. Analysis of the trial's data is still ongoing, and the results will be disclosed to the scientific community and shared with regulatory bodies.
In the United States, KEYTRUDA has been approved for two uses in melanoma: for the treatment of patients with inoperable or metastatic melanoma, and for the supplementary treatment of adult and pediatric (ages 12 and older) patients with Stage IIB, IIC, or III melanoma following complete surgical removal of the tumor.
Vibostolimab is an investigational anti-TIGIT antibody developed by Merck. It works by restoring the immune system's ability to fight tumors by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), which activates T lymphocytes to target and destroy tumor cells. Merck is conducting an extensive clinical program to assess the safety and effectiveness of the combined form of vibostolimab and pembrolizumab, both alone and in combination with other treatments, in more than 3,000 patients.
Ongoing Phase 3 trials evaluating the combined form of vibostolimab and pembrolizumab in lung cancer, which are overseen by external data monitoring committees, include KeyVibe-003, KeyVibe-006, KeyVibe-007, and KeyVibe-008. Safety reviews conducted by these committees have not led to any changes in the trials thus far. Based on the findings of the KeyVibe-010 trial, no modifications are expected in these ongoing studies.
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