Approval Probability
TA Base Rate
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Also known as Durvalumab, Durvalumab (Cohort 1-3), Durvalumab (MEDI4736), durvalumab
Durvalumab and Tremelimumab · 2 trials · 3 indications
Overall Response Rate (ORR) using Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ORR was defined as the number (percentage) of participants with a confirmed Complete Response (CR) or confirmed Partial Response (PR) and was estimated for each treatment arm with corresponding 2-sided 95% exact confidence intervals (CIs). A confirmed response of CR/PR meant that a response of CR/PR was recorded at one visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit, and not less than 4 weeks after the visit when the response was first observed, with no evidence of progression between the initial and CR/PR confirmation visit.
| Arm | Type | Description |
|---|---|---|
| Durvalumab and Tremelimumab | EXPERIMENTAL | Cycles/courses 1-3: Durvalumab 1.5g q4wks Tremelimumab 75 mg q4wks Cycles/courses ≥4: Durvalumab 1.5g q4wks Tremelimumab 75 mg q12wks |
| Doxorubicin | ACTIVE_COMPARATOR | Doxorubicin 75 mg/qm q3wks for 6 courses |
| ARM A | EXPERIMENTAL | - |
| ARM B | EXPERIMENTAL | - |
| ARM C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Durvalumab and Tremelimumab | BIOLOGICAL | immun checkpoint inhibitor |
| Doxorubicin | DRUG | Anthracycline |
| AZD1775 and carboplatin (CBPT) | DRUG | AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks. |
| AZD6738 and olaparib | DRUG | AZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks |
Inclusion Criteria: * 1\. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years at time of study entry 3. Body weight \> 3...
Durvalumab is an investigational antibody being studied for multiple cancers, including triple negative breast neoplasms, extensive-stage small cell lung cancer, invasive bladder cancer, metastatic non-small cell lung cancer, and non-small cell lung cancer. It is currently in Phase 3 clinical development and is not FDA approved.
Durvalumab is a monoclonal antibody (mab) that targets PD-L1, a protein that helps cancer cells evade the immune system. By blocking PD-L1, durvalumab aims to enhance the body's immune response against tumors. This mechanism is being evaluated across several oncology indications.
Durvalumab is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting multiple clinical trials to evaluate durvalumab as a potential treatment for various solid tumors.
Durvalumab is in Phase 3 clinical development for extensive-stage small cell lung cancer and other indications. It is an investigational drug, meaning it has not yet received FDA approval. Several Phase 3 trials are ongoing or completed, with a total of 8 clinical trials registered.
Durvalumab is being studied in 8 clinical trials, including NCT03043872 (CASPIAN), a Phase 3 trial combining durvalumab with tremelimumab and chemotherapy in untreated extensive-stage small cell lung cancer. Other trials include NCT03446547, NCT04449861, and NCT04712903, all evaluating durvalumab in lung cancer settings.
Durvalumab is also known as Durvalumab/Tremelimumab Combination Therapy, referring to its use in combination with tremelimumab. It is also referred to as Durvalumab (MEDI4736), Durvalumab + Chemotherapy, and SC durvalumab + rHu. These names describe different regimens or formulations of the same drug.