Non-small cell lung cancer, PD-L1 expression ≥ 1 per cent, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy
Characteristics
Start date
15.06.2025
–
Marketing authorisation:
15.05.2025
Resolution
04.12.2025
INN
Nivolumab
Brand name
Opdivo®
Pharm. company
Bristol-Myers Squibb GmbH & Co. KGaA
G-BA Procedure ID
D-1220
ATC code
L01FF01
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
Reason for procedure
New therapeutic indication
Therapeutic indication of the resolution
Opdivo is indicated in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by Opdivo as monotherapy for adjuvant treatment of resectable non-small cell lung cancer with tumour cellPD-L1 expression ≥ 1%, in adults at high risk of recurrence.
Subpopulation
Indication
Comparator
Erwachsene mit resezierbarem nicht-kleinzelligem Lungenkarzinom mit hohem Rezidivrisiko und einer Tumorzell-PD-L1-Expression ≥ 1 %; neoadjuvante und adjuvante Therapie
Studies and Results
Clinical trials
The CA209-77T trial is a double-blind, randomised Phase IIIstudy comparing nivolumab in combination with platinum-based chemotherapy during the neoadjuvant treatment phase, followed by nivolumab as monotherapy during the adjuvant treatment phase following surgery, with platinum-based chemotherapy during the neoadjuvant treatment phase, followed by placebo during the adjuvantphase following surgery.
Adults with resectable non-small cell lung cancer at high risk of recurrence and tumour cell PD-L1 expression ≥ 1%; neoadjuvant and adjuvant therapy
The additional benefit is not proven.
The CA209-77T study is not suitable for assessing additional benefit, as the appropriate comparator therapy specified by the G-BA for this resolution has not been implemented.
Consequently, there are no suitable data available for an assessment of the additional benefit of nivolumab in combination with platinum-based chemotherapy (neoadjuvant) followed by nivolumab as monotherapy (adjuvant).
Summary of the assessment
For adults with tumour cells-PD-L1 expression ≥ 1 % and a high risk of recurrence, there are no suitable data available for assessing the additional benefit of nivolumab in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by nivolumab as monotherapy for adjuvant treatment.
The CA209-77T study is not suitable for assessing additional benefit, as the appropriate comparator therapy specified by the G-BA for this resolution has not been implemented.
Consequently, an additional benefit over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
