Merck Pauses Phase 3 TIGIT Trial Due to Immune-Mediated Adverse Events

1. Merck has announced a temporary halt to its Phase 3 clinical trial of its TIGIT inhibitor due to immune-mediated adverse events that led to patient discontinuations.
2. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is an immune checkpoint receptor that is being investigated as a potential target for cancer immunotherapy.
3. The Phase 3 trial was evaluating the safety and efficacy of Merck's TIGIT inhibitor in combination with its PD-1 inhibitor, Keytruda, in patients with advanced solid tumors.
4. The decision to pause the trial was made after a review by an independent Data Monitoring Committee, which identified an imbalance in immune-mediated adverse events leading to discontinuations in the treatment arm.
5. Merck has stated that it is working closely with regulatory authorities and clinical trial investigators to review the data and determine the next steps for the trial.
6. This development underscores the potential risks and challenges associated with immunotherapy treatments, which can sometimes trigger severe immune responses.
7. The pause in the trial does not affect other ongoing trials involving Merck's TIGIT inhibitor or Keytruda.
8. Merck has not disclosed the specific nature of the immune-mediated adverse events or the number of patients affected.
9. The company has emphasized its commitment to patient safety and the importance of a thorough review of the trial data.
10. The outcome of this review could have significant implications for the future development and use of TIGIT inhibitors in cancer treatment.