Durvalumab (8) – Imfinzi®
Primarily advanced or recurrent endometrial cancer, combination with carboplatin and paclitaxel; maintenance therapy, combination with olaparib
Characteristics
| Start date | 01.09.2024 – Marketing authorisation: 26.07.2024 |
|---|---|
| Resolution | 20.02.2025 |
| INN | Durvalumab |
| Brand name | Imfinzi® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-1096 |
| ATC code | L01FF03 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C54.1Malignant neoplasm of endometrium |
| Alpha-ID codes (AIS) | I27788Endometrial carcinoma |
| Therapeutic area | Oncological diseases Endometrial cancer (EC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling Combination therapy |
| Therapeutic indication of the resolution |
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Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of primary advanced or recurrent endometrial cancer in adults who are eligible for systemic therapy, followed by maintenance treatment with Imfinzi in combination with olaparib in endometrial cancer with mismatch repair failure (pMMR). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma with mismatch repair failure (pMMR) who have not yet received systemic therapy as postoperative or adjuvant therapy to treat- primary advanced disease,- recurrent disease;- patients with newly diagnosed disease | Carboplatin + paclitaxel followed by watchful waiting |
| b) | Adult patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma with mismatch repair failure (pMMR) who have not yet received systemic therapy as postoperative or adjuvant therapy to treat- primary advanced disease,- recurrent disease;- patients with recurrent disease | Carboplatin + paclitaxel followed by watchful waiting |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DUO-E) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
a) Female patients with newly diagnosed disease
- The conclusion is that, for the group of patients with a newly diagnosed disease, durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, provides considerable additional benefit.
- The certainty of the evidence for the identified additional benefit is classified as an ‘indication’.
- mortality
- For the endpoint of overall survival, a statistically significant advantage was observed in the patient population of patients with newly diagnosed disease for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib.
- The extent of the prolongation in overall survival achieved is assessed as a marked improvement.
- Morbidity – Dyspnoea
- For the endpoint of dyspnoea (assessed using the EORTC QLQ-C30), a statistically significant disadvantage was observed with durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
- Morbidity – loss of appetite
- For the endpoint of loss of appetite (assessed using the EORTC QLQ-C30), there was a statistically significant disadvantage compared to durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
- Morbidity – constipation
- For the endpoint of constipation (assessed using the EORTC QLQ-C30), there was a statistically significant difference in favor of durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
- Morbidity – Patient Global Impression of Severity (PGIS)
- No statistically significant difference was observed between the treatment groups for symptoms assessed using the PGIS.
- Health-related quality of life – Cognitive functioning
- For the endpoint of cognitive functioning (assessed using the EORTC QLQ-C30), there was no statistically significant difference between the treatment groups.
- Side effects – severe adverse events (CTCAE grade ≥ 3)
- For the endpoint of severe adverse events, there was no statistically significant difference between the treatment groups.
- Side effects – Anaemia (severe adverse events)
- For the endpoint of anaemia (severe adverse events), there was a statistically significant disadvantage for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, compared with placebo in combination with carboplatin and paclitaxel, followed by placebo.
- Overall assessment
- In the overall analysis, the clear advantage in terms of overall survival is offset by moderate disadvantages in endpoints within the morbidity category.
- These disadvantages do not call into question the extent of the improvement in overall survival.
- No difference relevant to the benefit assessment was identified for the endpoint categories of health-related quality of life and side effects.
b) Patients with recurrent disease
- Consequently, no additional benefit is identified for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, in patients with recurrent disease.
- mortality
- In the patient population with recurrent disease, no statistically significant difference was observed between the treatment arms; consequently, no advantage can be inferred here.
- Morbidity – Patient Global Impression of Severity (PGIS)
- No statistically significant difference was observed between the treatment groups in terms of symptoms assessed using the PGIS.
- Health-related quality of life – Cognitive functioning
- For the endpoint of cognitive functioning (assessed using the EORTC QLQ-C30), there was no statistically significant difference between the treatment groups.
- Side effects – severe adverse events (CTCAE grade ≥ 3)
- For the endpoint of severe adverse events, there was no statistically significant difference between the treatment groups.
- Side effects – Anaemia (severe adverse events)
- For the endpoint of anaemia (severe adverse events), there was a statistically significant disadvantage for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, compared with placebo in combination with carboplatin and paclitaxel, followed by placebo.
- Overall assessment
- Overall, no differences relevant to the benefit assessment were observed in the endpoint categories of overall survival, health-related quality of life and side effects.
- With regard to morbidity, moderate disadvantages are observed.
Courtesy translation only, please refer to the German original.
Associated procedures
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