Pts with MET-altered aNSCLC documented by local testing reported here, received 2000 mg REGN5093 IV once every 3 weeks....As of Nov 21, 2022 the overall response rate (ORR) was 13% (9/70). Among the 65 pts evaluable for central lab confirmation of MET alterations, the ORR in TKI naïve pts was 27% (4/15) in pts with centrally confirmed MET ex14 mutations and 36% (5/14) in pts with confirmed MET Amp by FISH or NGS, in tissue or ctDNA, and MET protein overexpression by IHC (≥75% tumor cells with 3+).

44 pts (median age 66 years; 55% male; 66% Asian) were enrolled who received a total of 158 doses of REGN5093; total patient exposure was approximately 467 patient-weeks….As of 22 Nov 2021, of 36 pts who received the 2000 mg dose, 6 had a partial response (5 had prior anti–PD-(L)1 therapy). These responses occurred in 2/5 in pts with exon 14 skipping mutation who were naïve to MET tyrosine kinase inhibitor (TKI); 0/10 in pts with exon 14 skipping mutation previously treated with TKI; and 4/21 in MET TKI-naïve pts with MET gene amplification, protein overexpression, or both....These early results suggest REGN5093 may have a therapeutic benefit in pts with MET-altered NSCLC and showed promising efficacy signals with an acceptable safety profile.