Durvalumab
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Durvalumab
Durvalumab: Uterine ligament adenocarcinoma
One-Sentence Summary
Durvalumab is a PD-L1 immune checkpoint antibody. The knowledge graph records transitional cell carcinoma as its original indication (a relation recorded in the knowledge graph, not a confirmed approved indication). The TxGNN model predicts it may be effective for uterine ligament adenocarcinoma, but no clinical trials and no publications currently support this specific prediction. The prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Uterine ligament adenocarcinoma |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (2 of 2) – CDSCO approval status is not included in this data |
| Number of Listed Products | 2 (valid: 2) |
| Number of Approvals | 2 licences (both single-ingredient, valid) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Durvalumab is known as a PD-L1 inhibitor: by blocking PD-L1 it can restore T-cell antitumour activity. Its link to the original indication comes from the TxGNN model (deep learning); the score comes from the model and may reflect similarities the model learned between related diseases, not biological evidence.
Gynaecological adenocarcinomas could, in principle, express PD-L1 and respond to checkpoint blockade. However, this is only a hypothesis. No trial, publication or tumour-specific PD-L1 data for uterine ligament adenocarcinoma was provided, so the very high TxGNN score is a computational prediction only.
Other Predicted Indications (for context)
| Rank | Predicted Disease | TxGNN Score | Evidence Level |
|---|---|---|---|
| 2 | Endocervical carcinoma | 0.9991 | L5 (see note below) |
| 3 | Adenoid cystic carcinoma of the cervix uteri | 0.9991 | L5 |
| 4 | Uterine ligament serous adenocarcinoma | 0.9991 | L5 |
| 5 | Signet ring cell variant cervical mucinous adenocarcinoma | 0.9990 | L5 |
| 6 | Intestinal variant cervical mucinous adenocarcinoma | 0.9990 | L5 |
Note: the one trial linked to endocervical carcinoma is a Phase 1 study in recurrent or metastatic cervical, vaginal or vulvar cancer. It does not address the top-ranked disease, uterine ligament adenocarcinoma, and does not state which histologies were enrolled. It is therefore not counted as evidence for the top-ranked prediction.
Clinical Trial Evidence
Currently no related clinical trials registered for uterine ligament adenocarcinoma.
For reference, the nearest related study, listed under the rank-2 prediction (endocervical carcinoma):
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03452332 | Phase 1 | Completed | 20 | Hypofractionated radiotherapy plus durvalumab and tremelimumab in recurrent or metastatic cervical, vaginal or vulvar cancer; early safety and feasibility study, no efficacy results available |
Literature Evidence
Currently no related literature available for uterine ligament adenocarcinoma.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 108524 | Imfinzi Injection (AstraZeneca) | Vial of 10 ml injection | Indication text not available |
| Registration No. 108392 | Imfinzi Injection (AstraZeneca) | Vial of 2.4 ml injection | Indication text not available |
Safety Considerations
- Drug Interactions: 81 interactions were recorded. Examples:
- Major: adalimumab
- Moderate: corticosteroids (hydrocortisone, dexamethasone, prednisolone, prednisone, methylprednisolone, budesonide, betamethasone, triamcinolone, deflazacort), roflumilast, alefacept, alemtuzumab, anakinra, anthrax vaccine, tetanus toxoid vaccine
- Minor: zinc salts (acetate, gluconate, sulfate, chloride)
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for uterine ligament adenocarcinoma rests solely on a TxGNN score of 0.9992. No clinical trials or publications address this disease, so the evidence level is L5.
To proceed, the following is needed:
- Disease-specific evidence (trials, case series or PD-L1 expression data) for uterine ligament adenocarcinoma
- Mechanism of action data for durvalumab
- Package insert warnings and contraindications, which are required before any safety screening
- Indication text for the two licences, to confirm the approved uses in India
- If cervical cancer is of interest, a more relevant research question than the top-ranked disease, since the Phase 1 trial NCT03452332 offers early safety data in that setting
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.