Regeneron Pharmaceuticals...announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.

PD-L1≥1-49% First-Line Therapy...The following regimens added as Other Recommended...Cemiplimab-rwlc + paclitaxel + (carboplatin or cisplatin) (category 1). PD-L1≥1-49%....The following continuation maintenance regimens added...Cemiplimab-rwlc ± pemetrexed (category 1)

Cemiplimab + chemo showed improved efficacy compared with chemo alone in PD-L1–positive patients with advanced NSCLC.

Regeneron Pharmaceuticals...announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression....The positive opinion is supported by results from the global Phase 3 EMPOWER-Lung 3 trial...

This post-hoc analysis included pts with baseline liver mets from three phase 3 trials of cemiplimab (cemi; anti-PD-1) in non-small cell lung cancer (NSCLC) and cervical cancer...in EMPOWER-Lung 1 (1L treatment for advanced NSCLC with PD-L1 ≥50%), among pts with liver mets, cemiplimab monotherapy demonstrated notably longer OS (not reached vs 7.4 months; hazard ratio [HR] 0.38) and PFS (6.2 vs 4.2 months; HR 0.51), as well as higher ORR (29% vs 15%) vs chemo (Table). Similar improvement was observed for EMPOWER-Lung 3 Part 2 (1L cemiplimab+chemo vs placebo+chemo for advanced NSCLC with all PD-L1 levels). In EMPOWER-Cervical 1 (2L treatment of recurrent cervical cancer with all PD-L1 levels), cemiplimab showed comparable OS, PFS, and ORR vs chemo in the liver mets subgroup.

The Phase 3 trial of Sanofi and Regeneron’s PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy...Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels....Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death

Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p<0·0001)….Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population.

...Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory 4....

...Part 1 only: Expression of PD-L1 in ...

...Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory 4....

...Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory 4....

Patients were randomized 1:1 to cemiplimab 350 mg IV every 3 weeks or investigator’s choice of chemotherapy (NCT03088540)….Per independent review committee, median overall survival (OS, 18.7 vs 11.7 months), median progression-free survival (PFS, 10.4 vs 5.3 months), and objective response rate (ORR, 41.2% vs 8.8%) were superior with cemiplimab vs chemotherapy...1L cemiplimab monotherapy improved OS, PFS, and ORR vs chemotherapy, in patients with advanced NSCLC with PD-L1 ≥50%, and clinically stable brain metastases at baseline.