Trial results for a Phase 3 study comparing ociperlimab with tislelizumab against pembrolizumab in participants with untreated non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2026-05-12. The study was terminated, and results indicated that the experimental combination yielded a median overall survival of 31.9 months, compared to 29.4 months for the pembrolizumab arm, with no statistically significant difference.
Background
The terminated study investigated ociperlimab plus tislelizumab in comparison to pembrolizumab in adults with high levels of programmed cell death ligand-1 (PD-L1). The target population included individuals with locally advanced/recurrent or untreated metastatic non-small cell lung cancer (NSCLC). The primary objective was to evaluate the efficacy and safety of the ociperlimab and tislelizumab combination in this specific patient group.
Trial design
The terminated Phase 3 study (NCT04746924) enrolled 669 participants with non-small cell lung cancer (NSCLC). The trial's purpose was to evaluate the efficacy and safety of ociperlimab plus tislelizumab compared with pembrolizumab in adults with high levels of PD-L1, locally advanced/recurrent or untreated metastatic NSCLC. The primary endpoint for the study was not listed in the posted results. The study arms included Arm A: Ociperlimab Plus Tislelizumab and Arm B: Pembrolizumab Plus Placebo.
Key results
The trial reported overall survival (OS) data:
- In Arm A (Ociperlimab Plus Tislelizumab), the median overall survival was 31.9 months.
- In Arm B (Pembrolizumab Plus Placebo), the median overall survival was 29.4 months.
A Hazard Ratio (HR) of 0.97 (95% Confidence Interval: 0.76 to 1.23) was reported, with a p-value of 0.405. Additionally, a safety run-in substudy reported adverse events experienced by 7, 5, and 4 participants across different reporting instances.
What this means
The trial's termination means a full evaluation of the experimental combination's efficacy and safety against pembrolizumab in this population is not available. The reported overall survival data showed a numerical difference, with the ociperlimab plus tislelizumab arm having a median OS of 31.9 months compared to 29.4 months for the pembrolizumab arm. However, the associated Hazard Ratio of 0.97 and p-value of 0.405 indicate that this difference was not statistically significant. This suggests that the experimental combination did not demonstrate a superior overall survival benefit over pembrolizumab in the context of this terminated study. The limited adverse event data from a safety run-in substudy does not provide comprehensive safety insights for the full trial population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04746924, titled "A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer", were posted on 2026-05-12 on clinicaltrials.gov.