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)
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
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.
