Cemiplimab (2) – Libtayo®

Non-small cell lung carcinoma (NSCLC), first-line

Characteristics

Start date 01.08.2021 – Marketing authorisation: 21.06.2021
Resolution 20.01.2022
INN Cemiplimab
Brand name Libtayo®
Pharm. company Dossier: Sanofi-Aventis Deutschland GmbH
New distributor: Regeneron GmbH
G-BA Procedure ID D-705
ATC code L01FF06 PD-1/PDL-1 inhibitors (L01FF)
ICD-10 codes (AIS) C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung
Alpha-ID codes (AIS) I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas
DDD 17 mg P
Therapeutic area Oncological diseases Non-small-cell lung carcinoma (NSCLC)
Reason for procedure New therapeutic indication
Regulatory status Conditional Approval
Specialty Bundling

Therapeutic indication of the resolution

Libtayo is indicated as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) that expresses PDL1 (in ≥ 50% of tumour cells) and has no EGFR, ALK or ROS1 aberrations. The treatment is intended for:

- Patients with locally advanced NSCLC who are not candidates for definitive radiochemotherapy, or

- Patients with metastatic NSCLC.
Subpopulation Indication Comparator
Adults with locally advanced NSCLC who are not candidates for definitive radiochemotherapy or with metastatic NSCLC expressing PD-L1 in ≥ 50% of tumour cells and without EGFR, ALK or ROS1 aberrations; first-line therapy. Pembrolizumab

Studies and Results

No. of studies
(best subpopulation) 		1 (R2810-ONC-1624)
Study design
(best subpopulation) 		H2H vs. non-ACT + ITC (Bucher)
Meta analysis
(best subpopulation) 		no

  • Clinical trials
    • The R2810-ONC-1624 trial is an ongoing, open-label RCT comparing cemiplimab with platinum-based combination chemotherapy.

Adults with locally advanced NSCLC who are not candidates for definitive chemoradiotherapy, or with metastatic NSCLC that expresses PD-L1 in ≥ 50% of tumour cells and without EGFR, ALK or ROS1 aberrations; first-line treatment

  • An additional benefit is not proven.
  • Overall, there are therefore no suitable data available to assess the additional benefit of cemiplimab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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