Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab
Characteristics
Start date
01.08.2021
–
Marketing authorisation:
24.06.2021
Resolution
20.01.2022
INN
Nivolumab
Brand name
Opdivo®
Pharm. company
Bristol-Myers Squibb GmbH & Co. KGaA
G-BA Procedure ID
D-717
ATC code
L01FF01
PD-1/PDL-1 inhibitors (L01FF)
DDD
17
mg
P
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
Studies and Results
Clinical trials
The CA209-142 study is an ongoing, open-label, uncontrolled clinical study involving 7 cohorts in a multicentre setting, as part of a prospective Phase II cohort study.
Adults with metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H); following prior fluoropyrimidine-based combination therapy
An additional benefit is not proven.
Overall, the data presented are not sufficient to demonstrate an additional benefit of nivolumab in combination with ipilimumab compared with the appropriate comparator therapy, and therefore the additional benefit of nivolumab in combination with ipilimumab is not proven for the treatment of metastatic colorectal cancer with mismatch repair deficiency or high microsatellite instability in adults following prior fluoropyrimidine-based combination chemotherapy.
mortality
For the endpoint of overall survival, a comparison of individual arms from different studies (Study CA209-6EP) was presented using various methods.
Particularly due to significant uncertainties arising from the identification, completeness and adjustment for confounders, the analyses presented in the dossier for study CA209-6EP are not suitable for assessing the additional benefit of nivolumab in combination with ipilimumab.
The analyses submitted for study CA209-6EP are therefore not suitable for assessing the additional benefit of nivolumab in combination with ipilimumab.
morbidity
For the endpoint categories of morbidity and health-related quality of life, the pharmaceutical manufacturer carried out before-and-after comparisons using data from CA209-142 (Cohort 2).
The results of the before-and-after comparisons from the CA209-142 study (Cohort 2) are not suitable for assessing the additional benefit of nivolumab in combination with ipilimumab in the endpoint categories of morbidity and health-related quality of life, as they do not allow for a comparison with the appropriate comparator therapy.
Health-related quality of life
Disease symptoms and health-related quality of life are assessed in the CA209-142 study using the cancer-specific EORTC QLQ-C30 questionnaire.
Health status is assessed using the visual analogue scale (VAS) of the EQ-5D.
The results of the before-and-after comparisons in study CA209-142 (Cohort 2) are not suitable for assessing the additional benefit of nivolumab in combination with ipilimumab in the endpoint categories of morbidity and health-related quality of life, as they do not allow for a comparison with the appropriate comparator therapy.
Side effects
Overall, the descriptive comparison is not suitable for assessing the additional benefit of nivolumab in combination with ipilimumab.
Conclusion
Overall, the data presented are not suitable for demonstrating any additional benefit of nivolumab in combination with ipilimumab compared with the appropriate comparator therapy; therefore, no additional benefit of nivolumab in combination with ipilimumab is proven.
Courtesy translation only, please refer to the German original.
