Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Onivyde · 1 trial · 1 indication
The principal objective is to evaluate survival at 9 months in patients presenting with metastatic oesophageal squamous cell carcinoma (OSC) treated with Nal-IRI/LV5-FU or with paclitaxel.
| Arm | Type | Description |
|---|---|---|
| arm A: ONIVYDE | EXPERIMENTAL | ONIVYDE ONIVYDE will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14 ONIVYDE: 70 mg/m² intravenous over 90 minutes Folinic acid: 400 mg/m² intravenous over 30 minutes or L-folinic acid (racemic form L) 200 mg/m² over 30 minutes 5-FU: 2400 mg/m² over 46 hours |
| Arm B: TAXOL | ACTIVE_COMPARATOR | TAXOL Premedication consists of corticosteroids, H1 antihistamines and H2 antagonists during 30 minutes at time 1 hour before chemotherapy One cycle every 28 days (D1=D28) 80 mg/m2 IV over 60 minutes at D1, D8 and D15 |
| Name | Type | Description |
|---|---|---|
| Onivyde | DRUG | onivyde will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14. |
| Paclitaxel | DRUG | Paclitaxel : 80 mg/m2 IV during 60 minutes at D1, D8 and D15 |
Inclusion Criteria: * Histologically proven metastatic oesophageal squamous cell carcinoma * Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplat...
Onivyde is being studied as a second-line treatment for patients with metastatic oesophageal squamous cell carcinoma. It is an investigational small molecule in Phase 2 clinical development for this indication. The drug is being evaluated in a completed clinical trial that compared it to paclitaxel in this patient population.
Onivyde is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker TNGX. The company is conducting clinical research on this drug for the treatment of squamous cell carcinoma, specifically in the oncology therapeutic area.
Onivyde is in Phase 2 clinical development for squamous cell carcinoma. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy. The Phase 2 trial for this drug has been completed.
Onivyde has been studied in a Phase 2 clinical trial registered as NCT03719924. This trial evaluated the drug in combination with leucovorin and fluorouracil versus paclitaxel as second-line therapy in patients with metastatic oesophageal squamous cell carcinoma. The trial enrolled 106 participants and was conducted in France.
Onivyde is being studied in a biomarker-selected patient population, indicating that the clinical trial used specific biomarkers to select participants. However, the specific molecular target of Onivyde has not been disclosed in the available information. The drug is a small molecule modality used in oncology.