First-Line Pemetrexed plus @entity900 followed by XXXX Maintenance Therapy versus @entity4562 Monotherapy in East Asian Never-Smoker @entity1 with Locally Advanced or Metastatic Nonsquamous @entity1149 : Final Overall Survival Results from a Randomized Phase 3 Study.

@entity1 @entity4562 @entity470 @entity5 @entity1149 @entity900 @entity9512 @entity1349
INTRODUCTION: The primary analysis of this open-label, randomized, multicenter phase 3 study revealed no significant difference in progression-free survival between pemetrexed plus @entity900 followed by maintenance @entity4562 (PC/G) and @entity4562 monotherapy (G) in @entity1 with advanced nonsquamous @entity1149 ( @entity1149 ) and unknown @entity470 gene ( @entity470 ) mutation status; however, the hazard ratio favored PC/G. This report describes the final @entity1349 ( @entity1349 ) results. METHODS: Chemonaive, East Asian light ex-smokers/never-smokers with advanced nonsquamous @entity1149 and unknown @entity470 mutation status were randomized (1:1) to PC/G (n  = 118) or G (n  = 118). @entity470 mutation status was retrospectively determined for 76 @entity1 , 52 (68.4%) of whom had @entity470 -mutated @entity5 (exon 19 deletions in 26 and @entity9512 point mutation in 24). @entity1349 was analyzed by the Kaplan-Meier method. The study was registered at ClinicalTrials.gov (NCT01017874). RESULTS: Median @entity1349 was similar in the PC/G (26.9 months) and G (27.9 months) groups (hazard ratio  = 0.94, 95% confidence interval: 0.68-1.31, p  = 0.717). Median @entity1349 was longer with PC/G than with G in @entity1 with @entity470 wild-type @entity5 (28.4 versus 8.9 months) and longer with G than with PC/G in @entity1 with @entity470 -mutated @entity5 (45.7  versus 32.4 months), especially those with exon 19 deletions. Second-line postdiscontinuation therapy was common and included chemotherapy (PC/G, 41 of 118 [34.7%]; G, 73 of 118 [61.9%]) and rechallenge with an @entity470 tyrosine kinase inhibitor (PC/G, 27 of 118 [22.9%]; G, 9 of 118 [7.6%]). CONCLUSIONS: The progression-free survival and @entity1349 results from this study further demonstrate the importance of determining @entity470 mutation status to select the most appropriate first-line treatment for @entity1 with advanced @entity1149 .
