Pembrolizumab (trade name: Keytruda), the monoclonal antibody, has
been available for the treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) in adults whose tumors express the
T-cell receptor ligand PD-L1 and who have received a prior chemotherapy
The German Institute for Quality and Efficiency in Health Care
(IQWiG) examined in a dossier assessment whether the drug offers an
added benefit over the appropriate comparator therapy also for these
‘There is considerable added benefit of pembrolizumab in lung cancer patients for whom further chemotherapy (with docetaxel or pemetrexed) or nivolumab is an option.’
The findings revealed that there is an indication of considerable
added benefit of pembrolizumab for patients for whom further
chemotherapy (with docetaxel or pemetrexed) or nivolumab is an option.
For patients for whom these treatments are no longer indicated, however,
an added benefit is not proven.
No data for one of two research questions
The Federal Joint Committee (G-BA) distinguished two groups of
patients: patients for whom further chemotherapy with docetaxel or
pemetrexed or treatment with nivolumab is an option and patients for
whom this is not the case. For the first group, data from the KEYNOTE
010 study, which compared pembrolizumab with docetaxel, were available.
To assess an added benefit for the second group, the new drug would
have had to be compared with best supportive care, i.e. care optimized
for the individual patient to alleviate symptoms and improve quality of
life. Since no such study data were available, there was no hint of an
added benefit for this research question.
Advantages in mortality, morbidity and some side effects
The KEYNOTE 010 study showed an indication of considerable added
benefit in the patient-relevant outcome "overall survival", a hint of
considerable added benefit in the outcome category "morbidity"
(alopecia, sore mouth, and peripheral neuropathy), and several hints of
lesser harm of major or considerable extent in the category "side
effects" from the new drug.
This was offset by hints of considerably greater harm in
immune-related side effects. In the overall assessment, these did not
raise doubts about the positive effects, however. In summary, there is
therefore an indication of considerable added benefit of pembrolizumab
in comparison with the appropriate comparator therapy for this research
G-BA decides on the extent of added benefit
The dossier assessment is part of the early benefit assessment
according to the Act on the Reform of the Market for Medicinal Products
(AMNOG) supervised by the G-BA. After publication of the dossier
assessment, the G-BA conducts a commenting procedure and makes a final
decision on the extent of the added benefit.