Late-breaking ESMO presentation shows Libtayo monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of greater than 50%.- Regeneron + Sanofi.

Positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) were shared in a presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The trial compared Libtayo monotherapy to platinum-doublet chemotherapy in patients whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of greater than 50%.These results form the basis of regulatory submissions, including in the U.S. and European Union. Results :The late-breaking ESMO presentation expands on topline results shared in April. In the overall trial population (n=710), the median follow-up was 13 months for both Libtayo (n=356; range: <1-32 months and chemotherapy n="354;" range:><1-32 months. among these patients libtayo demonstrated the following results compared to chemotherapy: 32 reduced risk of death hazard ratio hr="0.68;" 95 confidence interval ci: 0.53-0.87 p="0.0022)." 22-month median overall survival os 95 ci: 18 months to not yet evaluable compared to 14 months 95 ci: 12-19 months. 41 reduced risk of disease progression hr="0.59;" 95 ci: 0.49-0.72 p><0.0001). the median progression-free survival pfs was 6.2 months 95 ci: 4.5-8.3 months compared to 5.6 months 95 ci: 4.5-6.1 months. 37 objective response rate orr 95 ci: 32-42 3 complete response cr and 33 partial response pr rate compared to 21 orr 95 ci: 17-25 1 cr and 20 pr rate. a prespecified analysis of data from patients whose cancers had confirmed pd-l1 expression greater than 50 n="563)" was also conducted : in this group the median follow-up was 11 months for both libtayo n="283;" range:><1-32 months and chemotherapy n="280;" range:><1-30 months and libtayo demonstrated the following results compared to chemotherapy:43 reduced risk of death hr="0.57;" 95 ci: 0.42-0.77 p="0.0002)." median os was not yet reached 95 ci: 18 months to not yet evaluable compared to 14 months 95 ci: 11-18 months. 46 reduced risk of disease progression hr="0.54;" 95 ci: 0.43-0.68 p><0.0001). the median pfs was 8 months 95 ci: 6-9 months compared to 6 months 95 ci: 5-6 months.39 orr 95 ci: 34-45 2 cr and 37 pr rate compared to 20 orr 95 ci: 16-26 1 cr and 19 pr rate. the trial also found a direct correlation between tumor response and pd-l1 expression level in libtayo-treated patients : the orr was highest 46 range: 36-56 in tumors with greater than 90 pd-l1 expression with target tumors shrinking by more than 40 after 6 months of treatment on average per last observation carried forward method. this correlation with pd-l1 expression level was not observed with chemotherapy. in the overall trial population the median duration of exposure to libtayo was 27 weeks range:><1-115 weeks and 18 weeks for chemotherapy range:><1-87 weeks. overall adverse events aes occurred in 88 of libtayo patients and 94 of chemotherapy patients. grade 3 or higher aes occurred in 37 of libtayo patients and 49 of chemotherapy patients. immune-mediated aes were reported in 17 of libtayo patients and included hypothyroidism 6 hyperthyroidism 4 pneumonitis 2 hepatitis 2 skin adverse reaction 2 arthritis increased blood thyroid stimulating hormone thyroiditis colitis nephritis and peripheral neuropathy each 1. treatment discontinuation due to an ae occurred in 6 of libtayo patients and 4 of chemotherapy patients. no new libtayo safety signals were observed.>