Double Flops For Merck's Lung Cancer Studies

Merck & Co Inc MRK announced full results from the Phase 2 KeyVibe-002 trial of vibostolimab/pembrolizumab combo, with or without docetaxel for metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. 

Data showed that vibostolimab/pembrolizumab plus docetaxel extended median progression-free survival (PFS) by 2.4 months compared to those treated with docetaxel alone, though the results did not reach statistical significance (5.6 months vs. 3.2 months); (p=0.0910). 

Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; p=0.9622).

Vibostolimab/pembrolizumab plus docetaxel improved overall survival (OS) compared with docetaxel alone, though these results did not reach statistical significance. 

Vibostolimab/pembrolizumab alone did not show an improvement in OS compared to docetaxel alone. 

The median OS for vibostolimab/pembrolizumab plus docetaxel was 10.2 months, 7.5 months for vibostolimab/pembrolizumab alone and 8.8 months for docetaxel. 

The overall response rate for patients receiving vibostolimab/pembrolizumab plus docetaxel was 29.9%, 6.0% for vibostolimab/pembrolizumab alone and 15.3% for docetaxel. 

The median duration of response (DOR) was 6.5 months for the vibostolimab/pembrolizumab plus docetaxel arm. Median DOR was not reached for the vibostolimab/pembrolizumab arm and the docetaxel arm.

Merck also announced that it will stop the Phase 3 KEYLYNK-008 of Keytruda in combination with maintenance Lynparza in metastatic squamous non-small cell lung cancer based on an independent Data Monitoring Committee recommendation.

At the interim analysis, Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not demonstrate an improvement in overall survival (OS) compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo.

The study's other dual primary endpoint, progression-free survival (PFS), was not statistically significant, but there was a numerical improvement compared to the control arm. 

Price Action: MRK shares are down 0.76% at $104.83 on the last check Thursday.