Cemiplimab (5) – Libtayo®

Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy

Characteristics

Start date 01.05.2023 – Marketing authorisation: 24.03.2023
Resolution 19.10.2023
INN Cemiplimab
Brand name Libtayo®
Pharm. company Dossier: Sanofi-Aventis Deutschland GmbH
New distributor: Regeneron GmbH
G-BA Procedure ID D-935
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
Therapeutic area Oncological diseases Non-small-cell lung carcinoma (NSCLC)
Reason for procedure New therapeutic indication
Specialty Bundling ACT change

Therapeutic indication of the resolution

Libtayo is indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC that expresses PD-L1 (in ≥ 1% 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
a) Adults with locally advanced or metastatic NSCLC with PD-L1 expression ≥ 50% without EGFR, ALK or ROS1 aberrations; first-line therapy - Pembrolizumab as monotherapy or - Atezolizumab as monotherapy or - Cemiplimab as monotherapy or - Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) or - Pembrolizumab in combination with carboplatin and either paclitaxel or nabPaclitaxel (only for patients with ECOG PS 0-1 and squamous NSCLC) or - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients with ECOG PS 0-1 and non-squamous NSCLC) or - Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin (only for patients with ECOG PS 0-1 and non-squamous NSCLC) or - Atezolizumab in combination with nab-paclitaxel and carboplatin (only for patients with ECOG PS 0-1 and non-squamous NSCLC)
b) Adults with locally advanced or metastatic NSCLC with PD-L1 expression ≥ 1 % to < 50 % without EGFR, ALK or ROS1 aberrations; first-line therapy - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients with ECOG PS 0-1 and non-squamous NSCLC) or - Pembrolizumab in combination with carboplatin and either paclitaxel or nabPaclitaxel (only for patients with ECOG PS 0-1 and squamous NSCLC) or - Atezolizumab as monotherapy (only for patients with PD-L1 expression ≥ 10 % in tumour-infiltrating immune cells) or - Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin (only for patients with ECOG PS 0-1 and a non-squamous NSCLC) or - Atezolizumab in combination with nab-paclitaxel and carboplatin (only for patients with ECOG PS 0-1 and non-squamous NSCLC) or - Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) or - Carboplatin in combination with a third-generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) cf. Annex VI to Section K of the Pharmaceutical Guideline (only for patients with ECOG PS 2) or - Carboplatin in combination with nab-paclitaxel (only for patients with ECOG PS 2). Translated with www.DeepL.com/Translator (free version)

Studies and Results

No. of studies
(best subpopulation) 		1 (EMPOWER-Lung 3) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + ITC (Bucher))
Reason for dividing into subpopulations (G-BA) Disease stage
ACT change 13.04.2023 – neue Leitlinien

  • Clinical trials
    • The EMPOWER-Lung 3 trial is an ongoing, double-blind, randomised, controlled Phase III trial comparing cemiplimab plus platinum-based chemotherapy with placebo plus platinum-based chemotherapy, which is being conducted at 74 trial centres in Europe and Asia.
    • The KEYNOTE 024 trial is an open-label, randomised, controlled Phase III trial comparing pembrolizumab with platinum-based combination chemotherapy, which was conducted from 2014 to 2016 at 142 trial centres in North America, Europe and Australia/New Zealand.
    • The KEYNOTE 042 trial is an open-label, randomised, controlled Phase IIItrial comparing pembrolizumab with a combination of carboplatin and either paclitaxel or pemetrexed, which was conducted from 2014 to 2022 at 196 trial centres in North and South America, Asia and Eastern Europe.
    • The KEYNOTE 189 trial is an ongoing, double-blind, randomised, controlled Phase IIIstudy comparing pembrolizumab plus platinum-based chemotherapy with platinum-based chemotherapy alone, which is being conducted at 143 study centres, including in Europe and North America.
    • The KEYNOTE 407 trial is an ongoing, double-blind, randomised, controlled Phase IIIstudy comparing pembrolizumab plus carboplatin-based chemotherapy with carboplatin-based chemotherapy alone, being conducted at 125 study centres, including in Europe, North America and Asia.

a) Adults with locally advanced or metastatic NSCLC with PD-L1 expression ≥ 50% and no EGFR, ALK or ROS1 aberrations; first-line treatment

  • An additional benefit is not proven.
  • Overall, no additional benefit has been demonstrated for cemiplimab in combination with platinum-based chemotherapy compared with the appropriate comparator therapy for adults with locally advanced or metastatic NSCLC with PD-L1 expression ≥ 50 % and no EGFR, No proof of ALK or ROS1 aberrations.
  • Overall review
    • When forming the relevant patient populations from the KEYNOTE trials, the pharmaceutical manufacturer only included in the adjusted indirect comparison the results of those patients for whom, according to a retrospective survey, carboplatin represented a suitable treatment option.
    • Significant proportions of the study populations in the KEYNOTE trials were therefore not included in the analyses. No such restriction of the populations was applied to the EMPOWER-Lung 3 trial.
    • There are therefore significant uncertainties regarding the comparability of the study populations between the studies presented, meaning that the indirect comparisons are not suitable for benefit assessment.

b) Adults with locally advanced or metastatic NSCLC with PD-L1 expression of ≥ 1 % to < 50 % and no EGFR, ALK or ROS1 aberrations; first-line treatment

  • The additional benefit is not proven.
  • Overall, there is no evidence of additional benefit for cemiplimab in combination with platinum-based chemotherapy compared with the appropriate comparator therapy for adults with locally advanced or metastatic NSCLC with PD-L1 expression of ≥ 1 % to < 50 % and no EGFR, There is no proof of ALK or ROS1 aberrations.
  • Overall review
    • When forming the relevant patient populations from the KEYNOTE trials, the pharmaceutical manufacturer only included in the adjusted indirect comparison the results of those patients for whom, according to a retrospective survey, carboplatin represented a suitable treatment option.
    • Relevant proportions of the study populations in the KEYNOTE trials were therefore not included in the analyses. No such restriction of the populations was applied to the EMPOWER-Lung 3 trial.
    • Furthermore, the submitted analyses include a significant proportion of patients with PD-L1 expression < 1 per cent, who – given the marketing authorisation for cemiplimab in combination with platinum-based chemotherapy – are not the subject of the assessment.
    • There are therefore significant uncertainties regarding the comparability of the study populations between the studies presented, meaning that the indirect comparisons are not suitable for benefit assessment.

Courtesy translation only, please refer to the German original.

Associated procedures



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