MSD (Merck & Co) has discontinued the Phase III KeyVibe-008 trial designed to evaluate a fixed-dose combination of vibostolimab and pembrolizumab with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC).
The company’s decision follows a recommendation from an independent Data Monitoring Committee (DMC) after a pre-planned analysis indicated that the trial’s primary endpoint of overall survival (OS) met pre-specified futility criteria.
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Vibostolimab is an investigational anti-TIGIT antibody developed to activate T lymphocytes and help destroy tumour cells.
The randomised, double-blind Phase III trial aimed to assess the co-formulation of vibostolimab and MSD’s anti-PD-1 therapy pembrolizumab (Keytruda), along with chemotherapy against atezolizumab in combination with chemotherapy, for the first-line treatment of ES-SCLC patients.
It enrolled 460 patients and the secondary endpoints focused on progression-free survival and objective response rate.
Patients in the fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs than those in the control arm.
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By GlobalDataMSD is now conducting a comprehensive analysis of the study.
Investigators have been informed that patients should cease treatment with the fixed-dose combination and may opt for atezolizumab treatment instead.
MSD, however, is continuing with its clinical development programme in lung cancer, focusing on earlier stages of the disease and new combinations.
Other ongoing Phase III studies of the vibostolimab and pembrolizumab combination in lung cancer are KeyVibe-003, KeyVibe-006 and KeyVibe-007.
Last week, MSD and Daiichi Sankyo dosed the first subject in the Phase III IDeate-Lung02 clinical trial of ifinatamab deruxtecan (I-DXd) in people with relapsed small cell lung cancer (SCLC).
