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)
DDD
17
mg
P
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
Specialty
Bundling
Studies and Results
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.
