Durvalumab

Evidence Level: L5

Predicted Indications: 6

Durvalumab

Pharmacist Assessment Report

Durvalumab: From Transitional Cell Carcinoma to Uterine Ligament Adenocarcinoma

One-Sentence Summary

Durvalumab has a recorded relation to transitional cell carcinoma in the knowledge graph. In Australia it is marketed as Imfinzi. The TxGNN model predicts it may be useful for uterine ligament adenocarcinoma. However, no clinical trials and no publications were found for this disease, so the prediction currently rests on the model score alone.

Quick Overview

Item	Content
Original Indication	Transitional cell carcinoma (a relation recorded in the knowledge graph; the Australian licence record contains no approved indication text)
Predicted New Indication	Uterine ligament adenocarcinoma
TxGNN Prediction Score	0.9992
Evidence Level	L5
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Durvalumab is generally understood to be an anti-PD-L1 antibody, a type of immune checkpoint inhibitor. This comes from general knowledge of the drug class, not from the compiled data.

A possible rationale is that some gynaecological adenocarcinomas may depend on PD-L1 signalling to evade the immune system. In that case, blocking PD-L1 could be relevant. This is speculative. No study in the compiled data examines PD-L1 biology or durvalumab response in uterine ligament adenocarcinoma, and the link to the original tumour type cannot be verified.

The model score is very high (0.9992), but it is a statistical prediction and not evidence of clinical benefit.

Clinical Trial Evidence

Currently no related clinical trials registered for uterine ligament adenocarcinoma.

Literature Evidence

Currently no related literature available for uterine ligament adenocarcinoma.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 11911X	Imfinzi	Solution concentrate for I.V. infusion, 120 mg in 2.4 mL	Not stated in the licence record compiled for this report

This is a single-ingredient product and its licence status is valid.

Cytotoxicity

Durvalumab is used in cancer, so this section is included.

Item	Content
Cytotoxicity Classification	Immunotherapy (anti-PD-L1 antibody, not a conventional cytotoxic)
Myelosuppression Risk	Please refer to the Product Information (PI) warnings and precautions
Emetogenicity Classification	Please refer to the Product Information (PI) warnings and precautions
Monitoring Items	Please refer to the Product Information (PI) warnings and precautions
Handling Protection	Please refer to the Product Information (PI) and local institutional policy

Safety Considerations

Drug Interactions: The interaction screen returned 81 interactions. The first 20 are summarised here.

Major: adalimumab.
Moderate:
- Corticosteroids: hydrocortisone, triamcinolone, dexamethasone, betamethasone, budesonide, prednisolone, prednisone, methylprednisolone and deflazacort.
- Immunomodulators: alefacept, alemtuzumab and anakinra.
- Others: roflumilast, a tetanus toxoid vaccine and an anthrax vaccine.
Minor: zinc salts (acetate, gluconate, sulfate and chloride).

Many of these are immunosuppressive or immune-modulating agents, so co-prescribing needs careful review.

For warnings and contraindications, please refer to the TGA-approved Product Information (PI) for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no supporting trials or publications for this specific disease, so the evidence level is L5. The mechanistic link cannot be checked because MOA data are missing. The licence record also lists no approved indication text.

To proceed, the following is needed:

Any clinical or preclinical study directly examining durvalumab in uterine ligament adenocarcinoma, such as case series, PD-L1 expression data or trial registrations.
Detailed mechanism of action data.
The TGA Product Information (PI), to confirm the approved indications, warnings and contraindications.
A separate review of the neighbouring prediction, endocervical carcinoma (score 0.9991). It has one completed Phase 1 trial (NCT03452332, n=20, radiotherapy with durvalumab and tremelimumab). This trial addresses safety and feasibility, not efficacy, but it may be a better-supported starting point.
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.