Pembrolizumab (23) – Keytruda®
Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy.
Characteristics
| Start date | 01.08.2022 – Marketing authorisation: 25.04.2022 |
|---|---|
| Resolution | 19.01.2023 |
| INN | Pembrolizumab |
| Brand name | Keytruda® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-838 |
| ATC code | L01FF02 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 | 9.5 mg P |
| Therapeutic area | Oncological diseases Colorectal cancer (CRC) / Small intestine cancer |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Keytruda is indicated as monotherapy of colorectal cancer with MSI-H or with a dMMR as follows in adults: - For the treatment of unresectable or metastatic colorectal cancer (CRC) after prior fluoropyrimidine-based combination therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with non-resectable or metastatic colorectal cancer (CRC) with high-frequency microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR); after prior fluoropyrimidine-based combination therapy. | A patient-specific therapy depending on the type and number of previous therapies, the RAS and BRAF mutation status, the location of the primary tumor, the general condition and the risk of toxicity induced by anti-VEGF and anti-VEGFR substances with a choice of: - 5-fluorouracil in combination with folinic acid and irinotecan (FOLFIRI) with or without bevacizumab or aflibercept or ramucirumab - 5-fluorouracil in combination with folinic acid and irinotecan (FOLFIRI) with or without cetuximab or panitumumab (only for patients with RAS wild type) - 5-fluorouracil in combination with folinic acid and oxaliplatin (FOLFOX) with or without bevacizumab - Capecitabine in combination with oxaliplatin (CAPOX) with or without bevacizumab - 5-Fluorouracil in combination with folinic acid with or without bevacizumab - Capecitabine with or without bevacizumab - Irinotecan as monotherapy - Panitumumab as monotherapy (only for patients with RAS wild type) - Cetuximab as monotherapy (only for patients with wild-type RAS) - Trifluridine/tipiracil - Irinotecan in combination with cetuximab (only for patients with wild-type RAS) - Encorafenib in combination with cetuximab (only for patients with BRAF V600E mutation) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (KEYNOTE-164) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + ITC (MAIC) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The KEYNOTE-164 trial is a single-arm Phase II trial conducted between August 2015 and February 2021 at 34 trial centres in North America, Europe, Asia and Australia, involving a total of 124 patients.
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 additional benefit compared with the appropriate comparator therapy, and therefore the additional benefit of pembrolizumab as monotherapy is not proven in adult patients with locally advanced, unresectable or metastatic colorectal cancer with MSI-H or dMMR following prior fluoropyrimidine-based combination therapy.
- Data basis
- In the dossier for the benefit assessment, the pharmaceutical manufacturer presents the results of the registration trial for pembrolizumab. This is the KEYNOTE-164 trial, which enrolled patients with locally advanced, unresectable or metastatic colorectal cancer with MSI-H or dMMR.
- In addition, the pharmaceutical manufacturer has submitted indirect comparisons with individual treatment options.
- Overall, the adjusted and non-adjusted indirect comparisons presented are not suitable for demonstrating additional benefit compared with the appropriate comparator therapy.
- Conclusion
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy, and therefore the additional benefit of pembrolizumab as monotherapy in adult patients with locally advanced, unresectable or metastatic colorectal cancer with MSI-H or dMMR following prior fluoropyrimidine-based combination therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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