Trial results for a Phase 2 study (NCT03609359) investigating pembrolizumab in combination with lenvatinib for advanced gastric cancer were posted on ClinicalTrials.gov on 2025-04-16. The study reported a median progression-free survival (PFS) of 7.1 months for the combination therapy.
Background
The study investigated the efficacy and safety of pembrolizumab (also known as Keytruda) in combination with lenvatinib for the treatment of advanced gastric cancer.
Trial design
The study (NCT03609359) was a Phase 2, single-arm trial that enrolled 29 participants with advanced gastric cancer. The trial evaluated the combination of lenvatinib and pembrolizumab to assess its efficacy and safety.
Key results
Key results from the trial included measurements for Objective Response Rate (ORR), immune-related Objective Response Rate (irORR), Progression-free Survival (PFS), and adverse events.
- For Objective Response Rate (ORR) in the Lenvatinib + Pembrolizumab group, the following participant counts were reported: 1 participant, 19 participants, 9 participants, 0 participants, and 0 participants.
- Similarly, for immune-related Objective Response Rate (irORR) in the Lenvatinib + Pembrolizumab group, the reported participant counts were: 1 participant, 19 participants, 9 participants, 0 participants, and 0 participants.
- The median Progression-free Survival (PFS) for the Lenvatinib + Pembrolizumab group was 7.1 months.
- Regarding safety, the number of participants with Adverse Events (AEs) in the Lenvatinib + Pembrolizumab group was 29 participants.
What this means
The reported median Progression-free Survival of 7.1 months offers an initial indication of the duration of disease control with the pembrolizumab and lenvatinib combination in patients with advanced gastric cancer. The finding that all 29 participants experienced adverse events highlights the importance of further investigation into the safety profile of this combination therapy, though specific details on severity or types of events were not provided in these results.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03609359, titled 'Lenvatinib and Pembrolizumab Simultaneous Combination Study,' were posted on 2025-04-16 on clinicaltrials.gov.