PracticeUpdate: What is the EMPOWER-Lung 3 Trial?
Dr. Henry: Late breaking abstract LBA 51, EMPOWER is spelled E-M, EMPOWER-Lung 3 trial. Cemiplimab in combination with platinum-doublet chemotherapy, first-line advanced non-small cell lung cancer is advanced non-small cell, stage IV first line. This is another PD-L1 inhibitor, cemiplimab, with platinum-doublet chemotherapy, squamous or non-squamous, they stratified of course PD-L1 levels, they randomized 2 to 1, delivered every 4 weeks.
PracticeUpdate: What were the trial outcomes?
Dr. Henry: Primary endpoint was overall survival, large number of patients, 466, the median OS (overall survival) 21.9 versus 13, strong hazard ratio of 0.71, and some other parameters just for your interest to show how it was very effective: progression-free survival 8.2 versus 5 months, hazard ratio strongly positive, disease control rate duration of response 15.6 versus 7.3 months. Of course, for the PD-L1's higher, in this coded study 51% or greater, people always do better. You're enriching your population where a checkpoint inhibitor might work. Hazard ratio is 0.61, progression-free 0.47, PD-L1 less than 1% there was still a response, but this is probably the chemo background entering in, not so much the inhibitor, the checkpoint inhibitor plus the chemotherapy. So while this works in all histologies, recall this was squamous or non-squamous, getting their chemo with or without this checkpoint inhibitor. Another strong trial, especially if you're PD-L1 enriched for consideration. Also in the States, we already have pembrolizumab (trade name Keytruda) plus chemotherapy with similar results. So now two checkpoint inhibitors with chemotherapy, patient enrichment with PD-L1 strong positive results.