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.>