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On Thursday, Merck & Co Inc (NYSE:MRK) announced discontinuing the Phase 3 KeyVibe-008 trial based on an independent Data Monitoring Committee (DMC) recommendation.
The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab and Keytruda (pembrolizumab), in combination with chemotherapy, compared to Roche Holdings AG’s (OTC:RHHBY) Tecentriq (atezolizumab) in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Also Read: FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug.
At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) 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.
Merck and Daiichi Sankyo recently announced that the first patient has been dosed in the IDeate-Lung02 Phase 3 trial of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed SCLC versus treatment of physician’s choice of chemotherapy.
Merck and Daiichi Sankyo also expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager that is currently being evaluated in a Phase 1/2 clinical trial.
The companies are planning to evaluate MK-6070 in combination with I-DXd in certain patients with SCLC, and other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics.
Price Action: MRK stock is up 0.82% at $113.09 at last check Thursday.
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