Libtayo® (cemiplimab) is now approved in Canada for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test with no EGFR, ALK, or ROS1 aberrations...

Regeneron Pharmaceuticals, Inc...and Sanofi today announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo® (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated:...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 expression positive (≥50%)…Adenocarcinoma, large cell, NSCLC NOS…Preferred…cemiplimab-rwlc (category 1) PD-L1 ≥50%....The following continuation maintenance regimens added...Cemiplimab-rwlc ± pemetrexed (category 1)

PD-L1 ≥50% First-Line Therapy...The following regimens added as Other Recommended...Cemiplimab-rwlc + paclitaxel + (carboplatin or cisplatin) (category 1). PD-L1 ≥50%....The following continuation maintenance regimens added...Cemiplimab-rwlc ± pemetrexed (category 1).

At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 26·1 months (95% CI 22·1–31·8; 149 [52%] of 284 died) versus 13·3 months (10·5–16·2; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 0·57, 95% CI 0·46–0·71; p<0·0001), median progression-free survival was 8·1 months (95% CI 6·2–8·8; 214 events occurred) in the cemiplimab group versus 5·3 months (4·3–6·1; 236 events occurred) in the chemotherapy group (HR 0·51, 95% CI 0·42–0·62; p<0·0001).

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).

Regeneron Pharmaceuticals...and Sanofi today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Libtayo (cemiplimab) as monotherapy in two advanced cancers...The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells...The positive opinion for Libtayo in advanced NSCLC is based on results from a Phase 3 trial, which allowed for the enrollment of patients with disease characteristics...

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). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%)...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

In the cemiplimab arm (n=238), 33.6%, 31.9%, and 34.5% of patients had PD-L1 ≥90%, >60% to <90%, and ≥50% to ≤60%, respectively...Overall, the benefit (OS, PFS, and ORR) with cemiplimab was superior to chemotherapy, and incrementally associated with PD-L1 expression levels.

CO rate to cemiplimab was 73.9%. In the ITT population, cemiplimab was associated with higher response rate (36.5% vs 20.6%), longer median duration of response (21.0 months vs 6.0 months) and lower rates of Grade ≥3 adverse events regardless of attribution (37.2% vs 48.5%) compared to chemo. In this study, 1L cemiplimab monotherapy significantly improved OS and PFS vs chemo in pts with advanced NSCLC with PD-L1 ≥50%, despite high CO rate, providing rationale for cemiplimab as a new treatment option for this patient population.

...Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

In this study, 1L cemiplimab monotherapy significantly improved OS and PFS vs chemo in pts with advanced NSCLC with PD-L1 ≥50%....In the PD-L1 ≥50% ITT population...median OS was not reached (95% CI: 17.9–NE) with cemiplimab (n=283) vs 14.2 months (95% CI: 11.2–17.5) with chemo (HR, 0.54; 95% CI: 0.43–0.68; P<0.0001)...In the ITT population, cemiplimab was associated with higher response rate (36.5% vs 20.6%), longer median duration of response (21.0 months vs 6.0 months)...

Sanofi today announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo® (cemiplimab) to platinum-doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells.

In EMPOWER-Lung 1, pts were randomised 1:1 to CEMI 350 mg IV Q3W or investigator's choice of CHEMO….In all, 69/565 (12.2%) pts with PD-L1 ≥50% had treated, clinically stable brain metastases at randomization….CEMI showed superior efficacy outcomes vs CHEMO: longer median OS (not reached vs 20.7 mo; HR = 0.42, 0.20–0.87), longer median PFS (12.5 vs 5.3 mo; HR = 0.34, 0.18–0.63), a higher ORR (55.9% vs 11.4%) and a longer median duration of response (31.7 mo vs 12.5 mo; table)....Three-year follow up data shows durable clinical benefits and an acceptable safety profile with 1L CEMI monotherapy in subgroup analysis of pts with aNSCLC and brain metastases.

In EMPOWER-Lung 1 pts were randomised 1:1 to first-line (1L) cemiplimab monotherapy or chemo for NSCLC with ≥50% programmed cell death-ligand 1 (PD-L1) expression….In EMPOWER-Lung 1, at ∼3-year follow-up of pts with laNSCLC, 1L cemiplimab monotherapy led to a median overall survival (OS) of 26.1 vs 13.9 mo with chemo (HR: 0.67; 0.38–1.17; p = 0.1532). Progression-free survival (PFS) was 8.1 vs 6.2 mo (HR: 0.56; 0.34–0.95; p = 0.0286). Objective response rate (ORR) was 49% vs 31%. Median duration of response (DOR) was 18.8 vs 6.2 mo.

In this post-hoc analysis, patients with advanced NSCLC across multiple PD-L1 ≥50% subgroups, CEMI resulted in significant overall improvement and delayed TTD in GHS/QoL and multiple patient-reported cancer-related and lung cancer-specific functions and symptoms.

...we aimed to evaluate the efficacy and toxicity of first-line single-agent ICIs versus ICI combinations for advanced NSCLC patients with PD-L1 ≥ 50%....In terms of OS, cemiplimab provided the best benefit versus chemotherapy (HR: 0.57, 95% CI: 0.43-0.77)...

At a median follow-up of 11.6 months (interquartile range 7.2–18.2 months), cemiplimab provided significantly better PFS vs chemotherapy and numerically longer OS...Objective response rates (ORR) and Kaplan–Meier estimated median duration of response (DOR) were also numerically improved with cemiplimab vs chemotherapy....In patients with laNSCLC and with PD-L1 ≥50%, 1L cemiplimab monotherapy demonstrated a significant improvement in PFS, numerically longer OS, and numerically better ORR and DOR vs chemotherapy.

At 2 yrs, numerically more pts receiving cemiplimab vs pembrolizumab were alive (59% vs 49%) and significantly more were alive w/o progression (37% vs 18%)....In advanced NSCLC pts with PD-L1 ≥50%, cemiplimab mono demonstrated significant improvements in PFS and ORR, and comparable OS, safety/tolerability vs pembrolizumab.