Nivolumab (18) – Opdivo®
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) |
| ICD-10 codes (AIS) | C18.0Malignant neoplasm of ileocecal valve, C18.1Malignant neoplasm of appendix, C18.2Malignant neoplasm of ascending colon, C18.3Malignant neoplasm of hepatic flexure, C18.4Malignant neoplasm of transverse colon, C18.5Malignant neoplasm of splenic flexure, C18.6Malignant neoplasm of descending colon, C18.7Malignant neoplasm of sigmoid colon, C18.8Malignant neoplasm of overlapping sites of colon, C18.9Malignant neoplasm of large intestine NOS, C19Malignant neoplasm of rectosigmoid junction, C20Malignant neoplasm of rectum |
| Alpha-ID codes (AIS) | I104488Malignant neoplasm of the rectosigmoid junction, I115345Carcinoma of the colon and sigmoid colon, I18119Malignant neoplasm of the rectum, I25671Malignant neoplasm of the flexura coli sinistra, I29955Malignant neoplasm of the colon, I29956Malignant neoplasm of the caecum, I29957Malignant neoplasm of the vermiform appendix, I29959Malignant neoplasm of the ascending colon, I29964Malignant neoplasm of the flexura coli dextra, I29966Malignant neoplasm of the transverse colon, I29971Malignant neoplasm of the descending colon, I29972Malignant neoplasm of the sigmoid colon |
| DDD | 17 mg P |
| Therapeutic area | Oncological diseases Colorectal cancer (CRC) / Small intestine cancer |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Opdivo is indicated in combination with ipilimumab for the treatment of metastatic colorectal cancer (CRC) with mismatch repair deficiency or high microsatellite instability in adults after prior fluoropyrimidine-based combination chemotherapy.
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| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with metastatic colorectal cancer (CRC) with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H); after prior fluoropyrimidine-based combination therapy. | 5-fluorouracil + folinic acid + irinotecan (FOLFIRI) ± bevacizumab or aflibercept or ramucirumab - 5-fluorouracil + folinic acid + irinotecan (FOLFIRI) ± cetuximab or panitumumab (only for patients with RAS wild type) - 5-fluorouracil + folinic acid + oxaliplatin (FOLFOX) ± bevacizumab - Capecitabine + oxaliplatin (CAPOX) ± bevacizumab - 5-fluorouracil + folinic acid ± bevacizumab - Capecitabine ± bevacizumab - Irinotecan as monotherapy - Panitumumab as monotherapy (only for patients with RAS wild type) - Cetuximab as monotherapy (only for patients with RAS wild type) - Trifluridine/tipiracil - Irinotecan + cetuximab (only for patients with RAS wild type) - Encorafenib + cetuximab (only for patients with BRAF V600E-mutation) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CA209-6EP) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + ITC (PID/PSM) |
|
Meta analysis
(best subpopulation) |
no |
- 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.
Associated procedures
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