Cemiplimab (Libtayo)

General information

Class/mechanism: PD-1 antibody. Cemiplimab is a recombinant human monoclonal antibody which binds to the PD-1 receptor on T-cells and blocks its interaction with PD-L1 and PD-L2, which immune system inhibition and facilitates anti-tumor immune response.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.

Toxicity management

• Immunotherapy toxicity management

Diseases for which it is established

• Cervical cancer
• Cutaneous basal cell carcinoma
• Cutaneous squamous cell carcinoma
• Non-small cell lung cancer
  • Non-small cell lung cancer, nonsquamous

Patient drug information

• Cemiplimab (Libtayo) package insert
• Cemiplimab (Libtayo) patient drug information (Chemocare)

History of changes in FDA indication

Cutaneous basal cell carcinoma

• 2021-02-09: Approved for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)
• 2021-02-09: Accelerated approval for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)

Cutaneous squamous cell carcinoma

• 2018-09-28: Approved for patients with metastatic cutaneous squamous cell carcinoma (CSCC). (Based on R2810-ONC-1423 and R2810-ONC-1540)
• 2018-09-28: Approved for patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. (Based on R2810-ONC-1423 and R2810-ONC-1540)

Non-small cell lung cancer

• 2021-02-22: Approved for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) 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. (New disease entity; based on EMPOWER-Lung 1)
• 2022-11-08: Approved in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. (Based on EMPOWER-Lung 3 part 2)

History of changes in EMA indication

• 2019-06-28: Initial conditional authorization as Libtayo.
• 2023-05-27: LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in at least 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation.
• 2023-05-27: LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in at least 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have metastatic NSCLC.
• 2023-05-27: LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. (Based on EMPOWER-Cervical 1)

History of changes in Health Canada indication

• 2019-04-10: Initial notice of compliance with conditions for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

History of changes in PMDA indication

• 2022-12-23: Initial approval

Also known as

• Code name: REGN-2810
• Generic name: cemiplimab-rwlc
• Brand name: Libtayo