Trial results for the study NCT03727880, investigating pembrolizumab with or without defactinib for resectable pancreatic ductal adenocarcinoma, were posted on ClinicalTrials.gov on 2026-02-04. The study reported a 0% pathologic complete response rate in both the combination arm and the pembrolizumab monotherapy arm.
Background
Pembrolizumab is a PD-1 antibody. Defactinib is a focal adhesion kinase (FAK) inhibitor. This study aimed to evaluate combining standard chemotherapy with pembrolizumab, with and without defactinib, for resectable pancreatic ductal adenocarcinoma (PDAC).
Trial design
The Phase 2 study (NCT03727880) investigated pembrolizumab with or without defactinib as neoadjuvant and adjuvant treatment for resectable pancreatic ductal adenocarcinoma. It enrolled 28 participants. The study compared two treatment arms: Arm A (pembrolizumab and defactinib) and Arm B (pembrolizumab alone). The trial aimed to assess effectiveness, safety, and immune response.
Key results
Key measurements from the trial included pathologic complete response (pCR) rate, overall survival (OS), disease-free survival (DFS), and the number of participants experiencing study drug-related toxicities.
- Pathologic Complete Response (pCR) Rate: 0% for both Arm A (Pembrolizumab and Defactinib) and Arm B (Pembrolizumab).
- Overall Survival (OS): Arm A showed a mean of 25.01 months (Standard Deviation: 14.48), while Arm B showed a mean of 27.39 months (Standard Deviation: 19.54).
- Disease Free Survival (DFS): Arm A showed a mean of 16.59 months (Standard Deviation: 14.33), while Arm B showed a mean of 15.99 months (Standard Deviation: 15.20).
- Study Drug-related Toxicities: 6 participants in Arm A experienced toxicities, compared to 3 participants in Arm B.
What this means
The Phase 2 trial results indicate that neither the combination of pembrolizumab and defactinib nor pembrolizumab monotherapy achieved a 0% pathologic complete response in participants with resectable pancreatic ductal adenocarcinoma. Overall survival and disease-free survival rates were comparable between the two arms. The combination arm reported a higher incidence of study drug-related toxicities (6 participants) compared to pembrolizumab monotherapy (3 participants). These findings suggest that adding defactinib did not improve efficacy and was associated with more toxicities in this setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov. The results for study NCT03727880, titled "Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma," were posted on 2026-02-04 on clinicaltrials.gov.