Small bowel carcinoma with MSI-H or dMMR, pre-treated
Characteristics
Start date
01.08.2022
–
Marketing authorisation:
25.04.2022
Resolution
19.01.2023
INN
Pembrolizumab
Brand name
Keytruda®
Pharm. company
MSD Sharp & Dohme GmbH
G-BA Procedure ID
D-841
ATC code
L01FF02
PD-1/PDL-1 inhibitors (L01FF)
DDD
9.5
mg
P
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
Specialty
Bundling
Studies and Results
Clinical trials
The KEYNOTE 158 trial is a multicentre, open-label, single-arm Phase II trial that has been ongoing since February 2016.
The Zaanan 2011 study is a retrospective study conducted by the Association des Gastroentérologues Oncologues (AGEO) study group.
Adults with unresectable or metastatic small bowel cancer with high-frequency microsatellite instability (MSI-H) or with a mismatch repair deficiency (dMMR) and disease progression during or after at least one previous course of treatment
An additional benefit is not proven.
Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy, and therefore additional benefit is not proven for pembrolizumab as monotherapy in adult patients with unresectable or metastatic small bowel cancer with MSI-H or dMMR and disease progression during or after at least one prior course of treatment.
Morbidity – Progression-free survival
For the endpoints of progression-free survival and severe adverse events, the pharmaceutical manufacturer provides a descriptive comparison of the results of the two studies.
Health-related quality of life
The results on morbidity and health-related quality of life from the KEYNOTE 158 study are presented as supplementary information.
Side effects – severe adverse events
For the endpoints of progression-free survival and severe adverse events, the pharmaceutical manufacturer provides a descriptive comparison of the results from the two studies.
Conclusion
Due to the lack of randomisation, these comparisons are subject to inherent uncertainty and do not constitute an adequate method of indirect comparison.
Furthermore, there are no effects for which it can be reliably ruled out that they are due solely to systematic bias.
Overall, the data presented are not suitable for demonstrating additional benefit over the appropriate comparator therapy; consequently, an additional benefit of pembrolizumab as monotherapy is not proven.
Courtesy translation only, please refer to the German original.
