The phase 3 trial was investigating the vibostolimab and pembrolizumab combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer.
RT’s Three Key Takeaways:
- Trial Discontinuation: Merck halted the phase 3 KeyVibe-008 trial for the vibostolimab and pembrolizumab combination with chemotherapy in extensive-stage small cell lung cancer due to meeting pre-specified futility criteria for overall survival and higher adverse event rates.
- Comparative Analysis: The combination therapy was being compared to atezolizumab with chemotherapy, with results showing the investigational combination had more adverse events and immune-related adverse events.
- Future Directions: Merck says it will continue to analyze the study data and remains committed to investigating new treatment approaches for small cell lung cancer.
Merck has discontinued the phase 3 KeyVibe-008 trial evaluating an investigational fixed-dose combination of vibostolimab and pembrolizumab in patients with extensive-stage small cell lung cancer based on the recommendation of an independent Data Monitoring Committee.
Vibostolimab is an anti-TIGIT antibody, and pembrolizumab (Keytruda) is Merck’s anti-PD-1 therapy. The drugs were being evaluated in combination with chemotherapy, compared to atezolizumab in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small-cell lung cancer.
At a pre-planned analysis, data showed that the primary endpoint of overall survival met the pre-specified futility criteria. Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs. A comprehensive analysis of this study is ongoing.
Merck is notifying study investigators of the decision and that patients should stop ongoing treatment with the fixed-dose combination of vibostolimab and pembrolizumab and be offered the option to be treated with atezolizumab. Results will be shared with the scientific community.
Small Cell Lung Cancer Treatment
“Small cell lung cancer remains a difficult disease to treat, as evident by the 7% five-year survival rate and limited advancements in treatment options,” says Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, in a release. “Innovative research plays a critical role in improving our understanding to help patients achieve better outcomes, and while we hoped the results would be different, we remain committed to investigating novel approaches to treat this debilitating disease. We are extremely grateful to all of the patients, caregivers, and investigators for their participation in this study.”
Ongoing phase 3 studies evaluating the vibostolimab and pembrolizumab fixed-dose combination in lung cancer, which are routinely monitored by external data monitoring committees, include KeyVibe-003, KeyVibe-006, and KeyVibe-007. Interim external data monitoring committee safety reviews have not resulted in any study modifications to date, and the studies are undergoing ongoing comprehensive safety monitoring.
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