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)
ICD-10 codes (AIS)
C17.0Malignant neoplasm of duodenum,
C17.1Malignant neoplasm of jejunum,
C17.2Malignant neoplasm of ileum,
C17.3Meckel´s diverticulum, malignant,
C17.8Malignant neoplasm of overlapping sites of small intestine,
C17.9Malignant neoplasm of small intestine, unspecified
Alpha-ID codes (AIS)
I107040Malignant neoplasm of the duodenojejunal junction,
I24721Malignant neoplasm of the jejunum,
I25404Malignant neoplasm of the duodenum,
I25410Malignant neoplasm of the ileum,
I25413Malignant neoplasm of the small intestine,
I29952Malignant neoplasm of a Meckel´s diverticulum
DDD
9.5
mg
P
Therapeutic area
Oncological diseases
Colorectal cancer (CRC) / Small intestine cancer
Reason for procedure
New therapeutic indication
Specialty
Bundling
Therapeutic indication of the resolution
Keytruda is indicated as monotherapy for the treatment of the following tumours with MSI-H or
with a a dMMR in adults:
- unresectable or metastatic small bowel carcinoma with disease progression during or after at least one prior therapy.
Subpopulation
Indication
Comparator
Adults with non-resectable or metastatic small bowel carcinoma with high-frequency microsatellite instability (MSI-H) or with mismatch repair deficiency (dMMR) and disease progression during or after at least one previous therapy
Treatment according to physician's choice
Studies and Results
No. of studies
(best subpopulation)
1
(KEYNOTE 158)
Study design
(best subpopulation)
Single-arm + other comparison
Meta analysis
(best subpopulation)
no
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.
