Nivolumab (29) – Opdivo®
Colorectal cancer with MSI-H or dMMR, first-line treatment, in combination with ipilimumab
Characteristics
| Start date | 15.06.2025 – Marketing authorisation: 19.12.2024 |
|---|---|
| Resolution | 18.12.2025 |
| INN | Nivolumab |
| Brand name | Opdivo® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-1189 |
| 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 |
| Therapeutic area | Oncological diseases |
| 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 colorectal cancer with mismatch repair deficiency or high microsatellite instability in adults in the following cases: – First-line treatment of unresectable or metastatic colorectal cancer |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene mit nicht resezierbarem oder metastasiertem Kolorektalkarzinom mit Mismatch-Reparatur-Defizienz oder hoher Mikrosatelliteninstabilität; Erstlinientherapie |
Studies and Results
- Clinical trials
- The CA209-8HW trial is an open-label, three-arm, randomised controlled trial that began in 2019 and is currently ongoing, comparing nivolumab in combination with nivolumab versus nivolumab versus chemotherapy as determined by the treating physician.
- The KEYNOTE 177 trial is a completed, open-label, randomised controlled trial comparing pembrolizumab with chemotherapy as determined by the treating physician.
Adults with unresectable or metastatic colorectal cancer with mismatch repair deficiency or high microsatellite instability; first-line treatment
- The additional benefit is not proven.
- Consequently, there are no data available in the overall review that would allow an assessment of the additional benefit.
- Overall review
- A key prerequisite for including studies in an adjusted indirect comparison via a bridge comparator is the similarity of the studies. In this regard, there are significant differences between the CA209-8HW and KEYNOTE 177 studies with respect to the testing of MSI-H and dMMR status.
- Consequently, against the backdrop of a result that is only just statistically significant, the data on overall survival are not suitable for drawing conclusions regarding additional benefit.
- Given the central importance of overall survival data in this therapeutic indication and for demonstrating additional benefit through indirect comparisons, and taking into account the limited data available on patient-relevant endpoints, the adjusted indirect comparison is, on the whole, assessed as unsuitable for drawing conclusions regarding additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
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