Durvalumab
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Durvalumab: From Transitional Cell Carcinoma to Prostatic Urethra Urothelial Carcinoma
One-Sentence Summary
Durvalumab is an anti-PD-L1 antibody originally used to treat transitional cell (urothelial) carcinoma. The TxGNN model predicts it may be effective for prostatic urethra urothelial carcinoma, with a very high score of 99.98%. However, no clinical trials and no publications specific to this site were found in the data compiled for this report, so support is indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Transitional cell carcinoma (urothelial carcinoma) |
| Predicted New Indication | Prostatic urethra urothelial carcinoma |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 (preclinical or mechanism-based rationale only; no site-specific studies) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Durvalumab is known to be an anti-PD-L1 monoclonal antibody. It blocks the PD-L1 pathway that tumours use to evade immune attack, and it is already used in urothelial carcinoma, its original indication.
Prostatic urethra urothelial carcinoma has the same urothelial histology as the original indication, so the same PD-L1 biology may apply. This is an extrapolation from histological similarity, not from direct data. The very high TxGNN score supports the prediction, but it is a computational result and not clinical proof.
For context, other predicted indications for this drug include urothelial variants with some trial activity (see "Related Evidence in Other Predicted Indications" below).
Clinical Trial Evidence
Currently no related clinical trials registered for prostatic urethra urothelial carcinoma.
Related Evidence in Other Predicted Indications
These trials concern related urothelial or gynaecological conditions, not the predicted indication above. They are shown for context only.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03912818 | Phase 2 | Terminated | 7 | Durvalumab with neoadjuvant chemotherapy in variant-histology bladder cancer. Terminated early, so no efficacy conclusions can be drawn. |
| NCT02812420 | Early Phase 1 | Active, not recruiting | 54 | Pre-surgical durvalumab plus tremelimumab in muscle-invasive, high-risk urothelial carcinoma in patients ineligible for cisplatin. No results available. |
| NCT03452332 | Phase 1 | Completed | 20 | Hypofractionated radiotherapy with durvalumab and tremelimumab in recurrent or metastatic cervical, vaginal or vulvar cancer. Gives early safety and feasibility information. |
Literature Evidence
Currently no related literature available for prostatic urethra urothelial carcinoma.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN15569P | IMFINZI Concentrate for Solution for Infusion 50 mg/ml | Infusion, solution concentrate | Not specified in the data compiled |
Safety Considerations
- Drug Interactions: 81 interactions were recorded. Examples are listed below.
- Major: Adalimumab
- Moderate: corticosteroids (hydrocortisone, triamcinolone, dexamethasone, betamethasone, budesonide, prednisolone, prednisone, methylprednisolone, deflazacort), roflumilast, alefacept, alemtuzumab, anakinra, tetanus toxoid and anthrax vaccines
- Minor: zinc salts (acetate, gluconate, sulfate, chloride)
Immunosuppressive agents such as corticosteroids may work against the immune-activating effect of durvalumab, so concurrent use should be reviewed carefully.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on histological similarity to the approved urothelial indication and a high model score. No trials or publications address prostatic urethra urothelial carcinoma specifically, and warnings and contraindications from the package insert are not available. Other urothelial variants (sarcomatoid bladder and upper-tract carcinoma) have early-phase trials and could be a more evidence-supported research focus.
To proceed, the following is needed:
- Site-specific clinical or observational data, or inclusion of prostatic urethra involvement in existing urothelial trials
- The Singapore package insert, covering approved indication, warnings and contraindications
- Detailed mechanism-of-action data
- Review of how existing pivotal urothelial trial results apply to this tumour site
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.