Endometrial cancer
The EU has approved 10 indications of 5 drugs in endometrial cancer. 3 of them need a biomarker result: MMR/MSI (3). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| dMMR / MSI-H3 | ||||
Imfinzi | Mismatch repair deficient (dMMR) | Monotherapy | Maint. advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy |
Jemperli | Monotherapy | 2L advanced | Progressed on or following prior treatment with a platinum-containing regimen | |
Keytruda | Monotherapy | Any line advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation | |
| pMMR / MSS2 | ||||
Imfinzi | Mismatch repair proficient (pMMR) | + olaparib | Maint. advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy |
Lynparza | Mismatch repair proficient | + durvalumab | Maint. advanced | After first-line treatment with durvalumab in combination with carboplatin and paclitaxel without progression |
| No biomarker required5 | ||||
Jemperli | None | + carboplatin and paclitaxel | 1L advanced | Candidates for systemic therapy |
Imfinzi | None | + carboplatin and paclitaxel | 1L advanced | Then maintenance (see the maintenance entries); Candidates for systemic therapy |
Keytruda | None | + carboplatin and paclitaxel | 1L advanced | Candidates for systemic therapy |
Lenvima | None | + pembrolizumab | Any line advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation |
Keytruda | None | + lenvatinib | Any line advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
Rozlytrekconditional | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older | |
| RET fusion1 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Biomarkers in endometrial cancer
Label wording10
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.
- Dostarlimab (Jemperli)
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
- Dostarlimab (Jemperli)
JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.
- Durvalumab (Imfinzi)
IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy
- Durvalumab (Imfinzi)
IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
- Durvalumab (Imfinzi)
IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
- Olaparib (Lynparza)
Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
- Lenvatinib (Lenvima)
LENVIMA in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.