Nivolumab (16) – Opdivo®
Renal cell carcinoma (RCC), first-line, combination with cabozantinib
Characteristics
| Start date | 01.05.2021 – Marketing authorisation: 13.04.2021 |
|---|---|
| Resolution | 21.10.2021 |
| INN | Nivolumab |
| Brand name | Opdivo® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-684 |
| ATC code | L01FF01 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C64Malignant neoplasm of kidney, except renal pelvis |
| Alpha-ID codes (AIS) | I19876Renal cell carcinoma |
| DDD | 17 mg P |
| Therapeutic area | Oncological diseases Renal cell carcinoma (RCC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling Combination therapy |
| Therapeutic indication of the resolution |
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|
OPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with non-pretreated advanced renal cell carcinoma (RCC) with favorable risk profile (IMDC score 0) | Pembrolizumab in combination with Axitinib |
| b) | Adult patients with non-pretreated advanced renal cell carcinoma (RCC) With intermediate (IMDC score 1-2) or unfavorable risk profile (IMDC score ≥ 3) | - Avelumab in combination with axitinib (only for patients with an unfavourable risk profile) or – Nivolumab in combination with ipilimumab or – Pembrolizumab in combination with axitinib |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CheckMate 9 ER) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
yes |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
a) Adult patients with previously untreated, advanced renal cell carcinoma with a favourable risk profile (IMDC score 0)
- Additional benefit is not proven for nivolumab in combination with cabozantinib compared with the appropriate comparator therapy.
- The adjusted indirect comparison submitted by the pharmaceutical manufacturer of nivolumab in combination with cabozantinib (CheckMate 9ER) versus pembrolizumab in combination with axitinib (KEYNOTE-426) includes patients with any risk profile.
- The pharmaceutical manufacturer has not provided a separate analysis of patient population a) from the adjusted indirect comparison of nivolumab in combination with cabozantinib versus pembrolizumab in combination with axitinib.
- Consequently, there are no suitable data available to assess the additional benefit of nivolumab in combination with cabozantinib for patient population (a).
b) Adult patients with untreated, advanced renal cell carcinoma with an intermediate (IMDC score 1–2) or unfavourable risk profile (IMDC score ≥ 3)
- An additional benefit of nivolumab in combination with cabozantinib compared with the appropriate comparator therapy is not proven.
- In the absence of direct comparative studies of nivolumab in combination with cabozantinib versus the appropriate comparator therapy, the pharmaceutical manufacturer presents a total of three adjusted indirect comparisons using the procedure described by Bucher et al.
- In doing so, it considers the following populations: patients with any risk profile, patients with an intermediate or unfavourable risk profile, and patients with an unfavourable risk profile.
- The pharmaceutical manufacturer does not allocate the results to the separate patient populations a) and b).
- Consequently, there is no separate analysis for patient population b) taking all three adjusted indirect comparisons into account.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of nivolumab in combination with cabozantinib for patient population b).
Courtesy translation only, please refer to the German original.
Associated procedures
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