Cecilia Brown

DocwireNews

The phase 3 KeyVibe-008 trial has been discontinued based on the recommendations of an independent data monitoring committee, according to an announcement from Merck.The trial was evaluating an investigational fixed-dose combination of the anti-TIGIT antibody vibostolimab and the anti&ndash;PD-1 therapy pembrolizumab plus chemotherapy and comparing it with atezolizumab plus chemotherapy as a first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).&ldquo;At a preplanned analysis, data showed that the primary end point of overall survival met the prespecified futility criteria,&rdquo; company officials said in announcement. &ldquo;Additionally, when compared [with] 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.&rdquo;Merck officials said they are notifying study investigators of the decision and that patients should stop treatment with fixed-dose vibostolimab and pembrolizumab and be offered atezolizumab as a treatment option. The trial results will be shared with the scientific community, according to the announcement.Ongoing phase 3 studies evaluating the vibostolimab and pembrolizumab fixed-dose combination in lung cancer include KeyVibe-003, KeyVibe-006, and KeyVibe-007. These studies are &ldquo;routinely monitored by external data monitoring committees,&rdquo; and &ldquo;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,&rdquo; according to Merck.Source: <a href="https://www.merck.com/news/merck-provides-update-on-phase-3-keyvibe-008-trial-evaluating-an-investigational-fixed-dose-combination-of-vibostolimab-and-pembrolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer/" target="_blank" rel="noopener">Merck</a>

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Phase 3 KeyVibe-008 Trial of Vibostolimab Plus Pembrolizumab in ES-SCLC Discontinued

Small Cell Lung Cancer

The phase 3 KeyVibe-008 trial has been discontinued based on the recommendations of an independent data monitoring committee.

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