Merck Stops Lung Cancer Drug Trial
- Merck has announced the discontinuation of the Phase 3 KeyVibe-008 trial for its lung cancer drug, pembrolizumab.
- This decision was made based on recommendations from an independent Data Monitoring Committee.
- The halt raises concerns about the drug's efficacy or safety in advanced lung cancer treatment.
A clinical trial is currently assessing the efficacy of a fixed-dose combination of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, alongside chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This new regimen is being compared to atezolizumab combined with chemotherapy, aiming to improve outcomes for patients facing this aggressive cancer. Adverse reactions associated with KEYTRUDA have been documented in several studies. In KEYNOTE-054, 14% of patients with stage III melanoma discontinued treatment due to adverse effects, with pneumonitis and colitis being the most common. Similarly, in KEYNOTE-042, 19% of patients with advanced non-small cell lung cancer (NSCLC) experienced adverse reactions, including pneumonitis and pneumonia, leading to treatment discontinuation. Further analysis from KEYNOTE-671 revealed that 18% of patients receiving KEYTRUDA in combination with platinum-based chemotherapy had to stop treatment due to adverse reactions, with acute kidney injury and interstitial lung disease being notable causes. In other trials, such as KEYNOTE-564 and KEYNOTE-868, serious adverse reactions were reported in 20% and 35% of patients, respectively, highlighting the potential risks associated with KEYTRUDA. KEYTRUDA is currently indicated for various cancer treatments, including recurrent or metastatic head and neck squamous cell carcinoma and advanced endometrial carcinoma. The ongoing trial aims to provide more insights into the safety and efficacy of this new combination therapy for lung cancer patients.