Durvalumab
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Durvalumab: Toward a New Indication — Prostatic Urethra Urothelial Carcinoma
(Original approved indication is not documented in this evidence pack — see Data Gap note below)
One-Sentence Summary
Durvalumab is an anti-PD-L1 monoclonal antibody (identified from clinical trial descriptions within this evidence pack, e.g. “Anti-PD-L1 Antibody (Durvalumab)” in NCT02812420); its original approved indication and formal mechanism-of-action record are not available in the current dataset (flagged as Data Gap DG002). The TxGNN model’s top-ranked prediction is Prostatic Urethra Urothelial Carcinoma (score 99.98%), but this specific prediction currently has zero clinical trials and zero publications supporting it — it is a pure model prediction (L5). Within the same evidence pack, a lower-ranked candidate, Endocervical Carcinoma (rank 6), has meaningfully stronger support (2 clinical trials + 1 review, L2).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in evidence pack (Data Gap) |
| Predicted New Indication | Prostatic Urethra Urothelial Carcinoma |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L5 |
| EU Market Status | Not marketed (Not Marketed) |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism-of-action (MOA) data for durvalumab is not available in this evidence pack (Data Gap DG002, severity: High), and the drug’s original approved indication is also absent from the dataset. However, clinical trial records elsewhere in this same evidence pack consistently describe durvalumab as an anti-PD-L1 immune checkpoint inhibitor antibody (e.g. NCT02812420, NCT03912818, NCT04065269, NCT03452332), which allows a mechanistic interpretation even without a formal MOA field.
For the top-ranked prediction, the model’s own rationale notes that prostatic urethra urothelial carcinoma is an anatomical sub-site of urothelial carcinoma, a tumour type in which anti-PD-L1 checkpoint blockade has an established biological rationale (PD-L1 expression driving immune evasion). The mechanistic logic is therefore plausible — the tumour lineage shares immune-microenvironment features with urothelial carcinomas already studied with durvalumab — but no clinical trial or literature evidence in this pack directly supports this specific sub-type, so the prediction currently rests entirely on the TxGNN model score (0.9998).
Notably, other candidates in this same evidence pack targeting related urothelial and PD-L1-relevant tumour types (kidney pelvis sarcomatoid transitional cell carcinoma, infiltrating bladder urothelial carcinoma sarcomatoid variant, and endocervical carcinoma) do have supporting trial and/or literature evidence, reinforcing that the underlying checkpoint-inhibition mechanism is being actively tested in adjacent disease areas — see “Other Predicted Indications” below.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
Currently no related literature available
Other Predicted Indications (Same Evidence Pack)
This evidence pack tracks 10 TxGNN-predicted indications for durvalumab. Ranked by TxGNN score, but evidence strength varies considerably — the strongest real-world support is found in Endocervical Carcinoma (rank 6, L2), not the top-ranked prediction.
| Rank | Predicted Disease | TxGNN Score | Evidence Level | Decision Stage | Recommendation | Supporting Evidence |
|---|---|---|---|---|---|---|
| 2 | Kidney pelvis sarcomatoid transitional cell carcinoma | 99.98% | L3 | S1 | Research Question | 1 trial: NCT02812420 (Early Phase 1, n=54, Grade B) |
| 3 | Infiltrating bladder urothelial carcinoma, sarcomatoid variant | 99.98% | L3 | S1 | Research Question | 2 trials: NCT03912818 (Phase 2, terminated, n=7, Grade C), NCT02812420 (Grade B) |
| 4 | Renal pelvis papillary urothelial carcinoma | 99.98% | L5 | S0 | Hold | None |
| 5 | Uterine ligament adenocarcinoma | 99.92% | L5 | S0 | Hold | None |
| 6 | Endocervical carcinoma | 99.91% | L2 | S2 | Proceed with Guardrails | 2 trials: NCT04065269 (Phase 2, n=174), NCT03452332 (Phase 1, completed, n=20); 1 literature: PMID 37467967 (Review, 2023) |
| 7 | Adenoid cystic carcinoma of the cervix uteri | 99.91% | L5 | S0 | Hold | None |
| 8 | Uterine ligament serous adenocarcinoma | 99.91% | L5 | S0 | Hold | None |
| 9 | Signet ring cell variant cervical mucinous adenocarcinoma | 99.90% | L5 | S0 | Hold | None |
| 10 | Intestinal variant cervical mucinous adenocarcinoma | 99.90% | L5 | S0 | Hold | None |
Note: none of the trials above are durvalumab monotherapy trials — all use durvalumab in combination (with tremelimumab, chemotherapy, radiotherapy, or an ATR inhibitor/olaparib), so even the best-supported candidate (endocervical carcinoma) lacks single-agent efficacy evidence.
EU Market Information
Durvalumab currently has 0 EU marketing authorization licenses recorded in this evidence pack; market status is marked as Not marketed (Not Marketed). No product name, dosage form, or approved indication text is available to tabulate.
Cytotoxicity
Durvalumab is an oncology therapeutic (anti-PD-L1 immune checkpoint inhibitor, identified from clinical trial descriptions in this pack) used across multiple carcinoma types, so this section applies.
| Item | Content |
|---|---|
| Cytotoxicity Classification | Immunotherapy (Anti-PD-L1 checkpoint inhibitor, per trial descriptions in this evidence pack) |
| Myelosuppression Risk | Please refer to the SmPC warnings and precautions |
| Emetogenicity Classification | Please refer to the SmPC warnings and precautions |
| Monitoring Items | Please refer to the SmPC warnings and precautions |
| Handling Protection | Please refer to the SmPC warnings and precautions |
Safety Considerations
Please refer to the SmPC for safety information.
(Note: key warnings, contraindications, and drug-drug interaction data are all flagged as Blocking Data Gaps (DG001) in this evidence pack — TFDA/SmPC labelling has not yet been retrieved.)
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction (Prostatic Urethra Urothelial Carcinoma) has no clinical trial or literature evidence — it is a pure model prediction (L5, decision stage S0). In addition, a Blocking-severity data gap (DG001: missing TFDA/SmPC warnings and contraindications) prevents this candidate from even entering the S1 safety pre-screen, regardless of efficacy evidence.
To proceed, the following is needed:
- Retrieve TFDA/SmPC warnings, contraindications, and full prescribing information (Blocking gap, DG001)
- Retrieve durvalumab’s formal mechanism-of-action and original approved-indication records (High-priority gap, DG002)
- If pursuing a repurposing candidate from this pack, consider re-scoping toward Endocervical Carcinoma (rank 6), which already has L2 evidence (2 trials + 1 review) and a “Proceed with Guardrails” recommendation — a substantially stronger starting point than the top TxGNN-ranked prediction
- Direct clinical trial or literature search specific to prostatic urethra urothelial carcinoma, since none currently exists in this pack
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.