Libtayo (cemiplimab-rwlc) - 4 indications

Scroll down for additional information for each indication:

• for the treatment of cutaneous squamous cell carcinoma; approved September 2018
• for patients with previously treated advanced basal cell carcinoma; approved February 2021
• for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression; approved February 2021
• for the first-line treatment of patients with advanced NSCLC with no EGFR, ALK or ROS1 aberrations; approved November of 2022

General Information

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody.

Libtayo is specifically indicated for the treatment of:

• patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation;
•  patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate
• for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. 
• in combination with chemotherapy for the first-line treatment of patients with advanced NSCLC with no EGFR, ALK or ROS1 aberrations with metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, irrespective of PD-L1 expression or histology

Libtayo is supplied as an intravenous solution. The recommended dosage is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. 

Mechanism of Action

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody. Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response.

Side Effects

Adverse effects associated with the use of Libtayo may include, but are not limited to, the following:

• fatigue
• rash
• diarrhea
• musculoskeletal pain
• nausea
• pruritus

Indication 1 - for the treatment of cutaneous squamous cell carcinoma

approved September 2018

Clinical Trial Results

The FDA approval of Libtayo for cutaneous squamous cell carcinoma was based on two open label clinical trials. A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment. After a median follow-up of 8.9 months, the treatment had reduced tumor volume in 47% of the 108 CSCC patients, with 61% of responses lasting six months or longer. Response rates for metastatic CSCC specifically were 47%, including 5% with complete responses. For inoperable, locally advanced CSCC, the response rate was 49%.

Indication 2 - for patients with previously treated advanced basal cell carcinoma

approved February 2021

Clinical Trial Results

The FDA approval of Libtayo for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, was based on an open-label, multi-center, non-randomized Phase 2 trial of patients with unresectable locally advanced BCC or metastatic BCC (nodal or distant). Patients received Libtayo 350 mg every 3 weeks. 112 patients were included in the efficacy analysis. Patients in both cohorts had either progressed on HHI therapy, had not had an objective response after 9 months on HHI therapy, or were intolerant of prior HHI therapy. The primary efficacy endpoint was confirmed objective response rate (ORR). In the metastatic BCC cohort the ORR was 21% and in the locally advanced BCC cohort the ORR was 31%. 

Indication 3 - for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression

approved February 2021

Clinical Trial Results

The open-label, randomized, multi-center Phase 3 trial, called EMPOWER-Lung 1, was designed to investigate the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations. PD-L1 expression was confirmed using the Agilent Dako PD-L1 IHC 22C3 pharmDx kit. The primary endpoints were OS and PFS. in the subset of patients proven to have PD-L1 expression of at least 50%, Libtayo reduced the risk of death by 43% compared to chemotherapy. The median OS was 22 months versus 14 months. The median PFS was 6.2 months versus 5.6 months.

Indication 4 - for the first-line treatment of patients with advanced NSCLC with no EGFR, ALK or ROS1 aberrations

Approved November of 2022

Clinical Trial Results

Approval was based on the global Phase 3 trial, EMPOWER-Lung 3, investigating Libtayo in combination with a physician's choice of platinum-doublet chemotherapy compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, irrespective of PD-L1 expression or tumor histology, and with no ALK, EGFR or ROS1 aberrations. 

The trial was stopped early based on a recommendation by the Independent Data Monitoring Committee after the Libtayo combination demonstrated a significant improvement in overall survival (OS), the primary endpoint. Efficacy results comparing the Libtayo combination to chemotherapy alone showed a 22-month median OS versus 13 months, representing a 29% relative reduction in the risk of death. The 12-month probability of survival was 66% for the Libtayo combination versus 56% for chemotherapy, per Kaplan-Meier estimates. The median PFS was 8 months versus 5 months, representing a 44% reduction in the risk of disease progression. The 12-month probability of PFS for the Libtayo combination was 38% versus 16% for chemotherapy. The overall response rate was 43% versus 23% and the median duration of response was 16-months versus 7 months.