Trial results for the NEOMUN study (NCT03197467) investigating pembrolizumab (Keytruda) in a neoadjuvant setting for resectable non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-04-04. The study reported a probability of 86.2% for disease-free survival at 6 months in the treated patient population.
Background
Pembrolizumab is an immunotherapy drug. This Phase 2 study, known as NEOMUN, investigated pembrolizumab in a neoadjuvant setting for patients with Stage II/IIIA non-small cell lung cancer (NSCLC) who were suitable for curative intent surgery.
Trial design
The NEOMUN study (NCT03197467) was an open-label, single-arm, prospective, monocenter, Phase 2 clinical trial. It enrolled 30 participants with non-small cell lung cancer (NSCLC) of Stage II/IIIA, suitable for curative intent surgery. The study investigated pembrolizumab in a neoadjuvant setting. 29 patients were treated in compliance with the protocol.
Key results
The trial results provided several outcome measurements for the pembrolizumab treatment arm:
- The probability of Disease-free Survival at 6 Months was reported as 86.2%.
- The median change in Tumor Size was -4.0 mm, indicating a reduction.
- The median change in PET Activity was -1 standardized uptake value [SUV].
- Regarding Tumor Response According to RECIST 1.1 Criteria, participant counts for various response categories were 0, 6, 19, and 3.
- For Tumor Response Evaluation - Pathologic Response, participant counts for various response categories were 4, 18, 3, and 4.
What this means
The results from the NEOMUN trial suggest that pembrolizumab, when used in a neoadjuvant setting for resectable Stage II/IIIA NSCLC, is associated with a notable 6-month disease-free survival probability of 86.2%. The observed median reductions in tumor size and PET activity further support its activity in this patient population. These findings provide initial insights into the potential benefit of neoadjuvant pembrolizumab for patients undergoing curative intent surgery for NSCLC.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03197467, titled "Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer," were posted on 2025-04-04 on clinicaltrials.gov.