Regeneron and Sanofi Present Results of Libtayo (cemiplimab) in P-III EMPOWER-Lung 3 Study as 1L Treatment of Advanced NSCLC at ESMO 2021

September 20, 2021 Auto Bot Clinical Trials 0

Shots:

  • The P-III EMPOWER-Lung 3 study evaluates Libtayo (350mg, q3w for 108wks.) + Pt doublet CT vs CT alone in a ratio (2:1) in 466 patients with LA/mNSCLC irrespective of histology & across all PD-L1 expression levels, 84% had an ECOG 1 performance status
  • The trial met its 1EPs & 2EPs i.e., improvement in OS in an overall population; m-OS (22 vs 13mos.) with 29% reduction in risk of death; probability of survival & PFS (66% & 56%) & (38% & 16%) @12mos; m-PFS (8 vs 5mos.) with 46% reduction in risk of disease progression; ORR (43% vs 23%) & m-DoR (16 vs 7mos.)
  • The therapy has improved pain symptoms, favorable PRO’s & no new safety signals observed. The median duration of exposure (38 & 21wks.)

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