Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2, first-line, combination with fluoropyrimidine- and platinum-based chemotherapy
Characteristics
Start date
01.01.2024
–
Marketing authorisation:
24.06.2021
Resolution
20.06.2024
INN
Pembrolizumab
Brand name
Keytruda®
Pharm. company
MSD Sharp & Dohme GmbH
G-BA Procedure ID
D-1024
ATC code
L01FF02
PD-1/PDL-1 inhibitors (L01FF)
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
Specialty
Bundling
ACT change
Studies and Results
Clinical trials
KEYNOTE 062 is a completed, multicentre, randomised controlled trial (RCT) comparing pembrolizumab as monotherapy with pembrolizumab in combination with chemotherapy, consisting of cisplatin + capecitabine or cisplatin + 5-FU, and against placebo in combination with this chemotherapy.
KEYNOTE 859 is a double-blind, multicentre RCT comparing pembrolizumab in combination with chemotherapy, consisting of cisplatin + 5-FU or oxaliplatin + capecitabine, with placebo in combination with this chemotherapy.
Adults with locally advanced, unresectable or metastatic HER2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction (GEJ) with PD-L1-expressing tumours (CPS ≥ 1); first-line treatment
An additional benefit is not proven.
mortality
The meta-analytical summary of the Keynote 859 and Keynote 062 studies shows a statistically significant advantage in survival time for the endpoint of overall survival with treatment using pembrolizumab + chemotherapy compared with chemotherapy, consisting of cisplatin + 5-fluorouracil or cisplatin + capecitabine or oxaliplatin + capecitabine.
The results from the Keynote 859 study show a median difference of 1.6 months, whilst no data on median survival were available for the KEYNOTE 062 study.
Taking into account the effect estimates from the individual studies and the meta-analytic summary, a relevant improvement can be observed at the endpoint level; however, it is not possible to reliably determine the extent of this advantage, which is minor but nevertheless significant.
The data presented on morbidity, health-related quality of life and side effects are considered unassessable, as key requirements for evidence of additional benefit are deemed not to have been met and this data set as a whole does not permit a proper assessment.
Overall assessment
Consequently, it is not possible, amongst other things, to weigh up the only minor advantage in the overall survival endpoint against the endpoints in the categories of morbidity, health-related quality of life and side effects.
In the overall assessment, therefore, no additional benefit can be established with the requisite certainty.
Courtesy translation only, please refer to the German original.
