Trial results for a Phase 2 study (NCT03184571) investigating pembrolizumab in combination with bemcentinib for advanced non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-09-25. The study reported an Objective Response Rate (ORR) of 10 participants in Cohort A, which included patients with previously treated adenocarcinoma of the lung.
Background
This study investigated the combination of pembrolizumab and bemcentinib in patients with advanced non-small cell lung cancer (NSCLC), specifically those with NSCLC Stage IV and adenocarcinoma of the lung, including cases of metastatic lung cancer.
Trial design
The Phase 2, open-label, multi-center, single-arm study (NCT03184571) enrolled 99 participants. The trial aimed to assess the anti-tumor activity and safety of bemcentinib in combination with pembrolizumab in patients with previously treated, advanced adenocarcinoma of the lung. The study enrolled three cohorts of participants: Cohort A consisted of participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy; Cohort B consisted of participants who received a maximum of one prior line of an anti-programmed [therapy]; and Cohort C consisted of participants with previously treated, advanced adenocarcinoma of the lung.
Key results
Key results from the study included Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), and Progression-free Survival (PFS).
- For Objective Response Rate (ORR): Cohort A reported an ORR in 10 participants. Cohort B and Cohort C each reported an ORR in 0 participants. The ORR for Total Patients was 10 participants.
- For Disease Control Rate (DCR): Cohort A achieved a DCR in 24 participants. Cohort B achieved a DCR in 12 participants. Cohort C achieved a DCR in 10 participants. The DCR for Total Patients was 46 participants.
- Regarding Duration of Response (DoR): The median DoR for Cohort A was 8.1 months. The median DoR for Total Patients was also 8.1 months.
- For Progression-free Survival (PFS): The median PFS for Cohort A was 35.7 weeks. The median PFS for Cohort B was 26.1 weeks.
What this means
The results from this Phase 2 single-arm study suggest that the combination of pembrolizumab and bemcentinib demonstrated some anti-tumor activity, particularly in Cohort A of patients with advanced adenocarcinoma of the lung who had received prior platinum-containing chemotherapy but no prior immunotherapy. The observed Objective Response Rate and Disease Control Rate in this cohort, along with median Duration of Response and Progression-free Survival, indicate potential benefit in this specific patient group. However, the absence of objective responses in Cohorts B and C highlights the need for further investigation into patient selection and treatment efficacy across different prior treatment histories.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03184571, titled "Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)," were posted on 2025-09-25 on clinicaltrials.gov.