Trial results for the Phase 3 KEYVIBE-007 study (NCT05226598) investigating pembrolizumab/vibostolimab coformulation (MK-7684A) in combination with chemotherapy for metastatic non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-11-13. The study found that the coformulation did not demonstrate an improvement in overall survival compared to pembrolizumab plus chemotherapy, with median overall survival of 19.4 months versus 23.5 months, respectively, in participants with PD-L1 TPS ≥1%.
Background
The KEYVIBE-007 study evaluated a coformulation of pembrolizumab, an established immunotherapy, with vibostolimab (MK-7684A) as a potential new treatment option for patients with metastatic non-small cell lung cancer.
Trial design
The KEYVIBE-007 study (NCT05226598) was a Phase 3, randomized trial that enrolled 739 participants with metastatic non-small cell lung cancer. The study compared the efficacy of pembrolizumab/vibostolimab coformulation (MK-7684A) in combination with chemotherapy (including carboplatin, cisplatin, paclitaxel, or nab-paclitaxel) against pembrolizumab plus chemotherapy. The primary hypothesis was to determine if the coformulation was superior with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Key results
The trial evaluated overall survival (OS) in two main populations:
- Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
- For the MK-7684A + Chemotherapy arm, the median OS was 19.4 Months.
- For the Pembrolizumab + Chemotherapy arm, the median OS was 23.5 Months.
- A Log Rank analysis reported a Hazard Ratio (HR) of 1.14 (95.0% CI: 0.87 to 1.5) with a p-value of 0.8335.
- Overall Survival (OS) in All Participants
- For the MK-7684A + Chemotherapy arm, the median OS was 20.0 Months.
- For the Pembrolizumab + Chemotherapy arm, the median OS was 19.7 Months.
- A Log Rank analysis reported a Hazard Ratio (HR) of 1.0 (95.0% CI: 0.82 to 1.23) with a p-value of 0.5104.
What this means
The results of the KEYVIBE-007 trial indicate that the combination of pembrolizumab/vibostolimab coformulation (MK-7684A) with chemotherapy did not demonstrate superiority in overall survival compared to pembrolizumab plus chemotherapy alone in participants with metastatic non-small cell lung cancer. Specifically, in the primary analysis population of PD-L1 TPS ≥1%, the median OS was numerically lower in the coformulation arm. These findings suggest that adding vibostolimab to pembrolizumab and chemotherapy did not provide additional clinical benefit in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05226598, titled "Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)," were posted on 2025-11-13 on clinicaltrials.gov.