Phase 3 trial of adjuvant pembrolizumab in resected NSCLC posts results after 86.6 months

A phase 3 randomized controlled trial (RCT) investigated adjuvant pembrolizumab versus placebo in 1177 participants with stage IB-IIIA non-small cell lung cancer (NSCLC) who had undergone surgical resection (lobectomy or pneumonectomy) with or without prior adjuvant chemotherapy. The study's primary outcome was disease-free survival (DFS), with a secondary outcome focusing on DFS in participants with a PD-L1 tumor proportion score (TPS) of 50% or higher. The median follow-up was 86.6 months.

For the primary outcome of DFS and the secondary outcome of DFS in PD-L1 strong positive (TPS ≥50%) participants, the specific results, effect sizes, absolute numbers, p-values, and direction of effect were not reported in the posted results. The study hypothesis was that pembrolizumab would improve DFS compared to placebo.

No data on adverse events, serious adverse events, discontinuations, or tolerability were reported. The study's lead sponsor was Merck Sharp & Dohme LLC. Key limitations include the lack of reported efficacy and safety results, which prevents any assessment of benefit-risk. The practice relevance cannot be determined until complete, peer-reviewed data are available.

A major pharmaceutical company has posted results from a large, late-stage clinical trial. The study tested whether the immunotherapy drug pembrolizumab helps prevent cancer from returning in people with early-stage non-small cell lung cancer after they have had surgery to remove the tumor. The trial involved 1,177 patients and compared the drug to a placebo over a follow-up period of more than 7 years.

The main goal of the study was to see if pembrolizumab improved disease-free survival, which is the length of time after treatment that a person lives without the cancer coming back. The researchers also looked specifically at patients whose tumors had high levels of a specific marker called PD-L1. However, the actual numerical results for survival have not been made public yet.

Because the detailed findings on survival and safety are not available, it is too early to know what this means for patients. The study was funded by the drug's manufacturer. Readers should know that these are posted results, not a full scientific publication, and the key data is still pending. Patients should talk with their oncologist about the latest, fully published evidence when considering treatment options after surgery.