Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI4736 (Durvalumab)
MEDI4736 · 18 trials · 15 indications
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Number of participants with Overall Survival (OS)
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
To compare the pathological complete response (pCR= ypT0 ypN0) rates of neoadjuvant treatment of sequential, nab-Paclitaxel followed by EC +/- the PD-L1 antibody MEDI4736 in patients with early triple negative breast cancer.
Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review \[BICR\]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. criteria are: Complete response \[CR\] = disappearance of all target lesions since baseline; and partial response \[PR\] = at least a 30% decrease in the sum of the diameters of target lesions.
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review \[BICR\]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. criteria are: Complete response \[CR\] = disappearance of all target lesions since baseline; and partial response \[PR\] = at least a 30% decrease in the sum of the diameters of target lesions.
Changes from baseline in laboratory parameters, vital signs, and ECGs
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as defined as the best response among all overall responses recorded from the start of treatment until progression, or the last evaluable disease assessment in the absence of progressive disease (PD) prior to the initiation of subsequent anti-cancer therapy, or discontinuation from the study, whichever occurs first.
The maximum tolerated dose (MTD), which is the highest dose within a cohort where no more than 1 out of 6 subjects experience DLTs or the highest protocol-defined dose for each agent in the absence of exceeding the MTD, will be evaluated using the following safety assessments: adverse events, serious advents, laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. Measurements will be aggregated to determine whether a subject has experienced a DLT as assessed by the investigator.
Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.
A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body weight, body temperature, blood pressure, pulse rate, and respiratory rate).
Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram (ECG) are reported. The data for \>0 participants with notable QT/QTc interval in local ECG from baseline are reported.
The ORR assessed by BICR in participants with non-squamous NSCLC who had received 2 or more prior lines of therapy is reported. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.
The ORR assessed by BICR in participants with squamous NSCLC who had received 1 and 2 or more prior lines of therapy is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.
The ORR assessed by BICR in participants with UC post-platinum PD-L1 status high 2L+ is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.
| Arm | Type | Description |
|---|---|---|
| Combination therapy | EXPERIMENTAL | Combination therapy (durvalumab + tremelimumab) : Patients will receive the combination therapy followed by monotherapy via intravenous (IV) infusion once Q4W: * Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) and * Durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab. |
| Monotherapy | EXPERIMENTAL | Monotherapy (Durvalumab 1,500 mg): Patients will receive durvalumab 1,500 mg via IV infusion Q4W on Week 0. |
| Standard of Care | ACTIVE_COMPARATOR | Standard of Care Chemotherapy Treatment |
| MEDI4736 | EXPERIMENTAL | MEDI4736 monotherapy |
| MEDI4736 + Tremelimumab | EXPERIMENTAL | MEDI4736 + tremelimumab combination therapy |
| MEDI4736 (durvalumab) monotherapy in Sub-study A | EXPERIMENTAL | MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors. |
| Standard of Care in Sub-study A | ACTIVE_COMPARATOR | Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors. |
| MEDI4736 (durvalumab) + tremelimumab in Sub-study B | EXPERIMENTAL | MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors. |
| Standard of Care in Sub-study B | ACTIVE_COMPARATOR | Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors. |
| MEDI4736 (durvalumab) monotherapy in Sub-study B | EXPERIMENTAL | MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors. |
| tremelimumab in Sub-study B | EXPERIMENTAL | tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors. |
| PLACEBO | PLACEBO_COMPARATOR | Placebo (matching placebo for intravenous infusion) |
| Taxane | ACTIVE_COMPARATOR | Nab-Paclitaxel 125 mg/m² weekly for 12 weeks |
| Epirubicin | ACTIVE_COMPARATOR | Epirubicin 90 mg/m² 2-weekly for 8 weeks |
| Cyclophosphamide | ACTIVE_COMPARATOR | Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks |
| Tremelimumab | EXPERIMENTAL | Tremelimumab monotherapy |
| MEDI4736 and tremelimumab | EXPERIMENTAL | - |
| MEDI4736 and AZD9150 | EXPERIMENTAL | - |
| Escalation | EXPERIMENTAL | MEDI4736 will be combined with gefitinib to assess safety and tolerability |
| Expansion Arm | EXPERIMENTAL | MEDI4736 will be combined with gefitinib |
| Dose Escalation | EXPERIMENTAL | MEDI4736 and tremelimumab received by intravenous infusion. |
| Arm A | EXPERIMENTAL | Medi4736 and tremelimumab received by intravenous infusion |
| Arm B | EXPERIMENTAL | MEDI4736 and tremelimumab received by intravenous infusion |
| Arm C | EXPERIMENTAL | MEDI4736 and tremelimumab received by intravenous infursion |
| MEDI4736 Q2W | EXPERIMENTAL | Evaluate MEDI4736 given every 2 weeks |
| MEDI4736 Q3W | EXPERIMENTAL | Evaluate MEDI4736 given every 3 weeks |
| MEDI4736 Dose Expansion | EXPERIMENTAL | evaluate MEDI4736 given every 2 weeks |
| MEDI4736 Q4W | EXPERIMENTAL | Evaluate MEDI4736 given every 4 weeks |
| MEDI4736 combined with another drug | EXPERIMENTAL | evaluate MEDI4736 in combination with another drug given every 4 weeks |
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | EXPERIMENTAL | Participants will receive intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Escalation Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Exploration Durvalumab 20 mg/kg (Q4W) | EXPERIMENTAL | Participants will receive IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion Non-SCCHN Cohort HPV positive (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with non-small-cell lung cancer (NSCLC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with hepatocellular carcinoma (HCC Total) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with advance cutaneous melanoma (ACM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with uveal melanoma (UM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with gastroesophageal cancer (GEC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with triple-negative breast cancer (TNBC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with pancreatic adenocarcinoma (PAC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with urothelial carcinoma (UC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with glioblastoma multiforme (GBM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with ovarian cancer (OC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with soft- tissue sarcoma (STS) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with small-cell lung cancer (SCLC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with microsatellite instability (MSI)-high cancer will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | EXPERIMENTAL | Participants with nasopharyngeal carcinoma (NPC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| MEDI4736 (Durvalumab) | BIOLOGICAL | A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC). |
| MEDI4736 (Durvalumab) + Tremelimumab | BIOLOGICAL | Durvalumab: A human mAb of IgG 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on IC. Tremelimumab: A human Ig G2 mAb that completely blocks the interaction of human CTLA-4 (cluster of differentiation \[CD\]152) with CD80 and CD86 and increase release of cytokines (interleukin \[IL\]-2 and interferon \[IFN\]-γ) from human T cells, peripheral blood mononuclear cells and whole blood. |
| Tremelimumab | DRUG | IV infusion |
| Cisplatin | DRUG | IV infusion |
| Carboplatin | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| MEDI4736 | BIOLOGICAL | Anti-PD-L1 antibody |
| MEDI4736+Tremelimumab | BIOLOGICAL | - |
| Cetuximab | BIOLOGICAL | Monoclonal Antibody |
| 5-fluorouracil (5FU) | DRUG | Chemotherapy Agent |
| MEDI4736 + Tremelimumab | DRUG | MEDI4736 + Tremelimumab combination therapy |
| Standard of Care | DRUG | Standard of Care |
| MEDI4736 (Durvalumab)+Tremelimumab | BIOLOGICAL | - |
| Paclitaxel + Carboplatin | DRUG | Chemotherapy Agents |
| Gemcitabine + Cisplatin | DRUG | Chemotherapy Agents |
| Gemcitabine + Carboplatin | DRUG | Chemotherapy Agents |
| Pemetrexed + Cisplatin | DRUG | Chemotherapy Agents |
| Pemetrexed + Carboplatin | DRUG | Chemotherapy Agents |
| Vinorelbine | DRUG | Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle. |
| Erlotinib | DRUG | Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration |
| MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) | DRUG | MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion |
| tremelimumab (anti-CTLA4) | DRUG | tremelimumab (anti-CTLA4) treatment by intravenous infusion |
| PLACEBO | OTHER | PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo). |
| MEDI4736 (Anti PD-L1) | DRUG | MEDI4736 1.5g total i.v. every 4 weeks As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by: MEDI4736 in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by MEDI4736 in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3). |
| nab-Paclitaxel | DRUG | nab-Paclitaxel 125 mg/m² weekly for 12 weeks |
| Epirubicin | DRUG | Epirubicin 90 mg/m² 2-weekly for 8 weeks |
| Cyclophosphamide | DRUG | Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks |
| AZD9150 | DRUG | AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion |
| Gefitinib | DRUG | Gefitinib QD |
Inclusion criteria: 1. Must have a life expectancy of at least 12 weeks. 2. Age ≥18 years at the time of screening. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative 3. Capable of givin...
MEDI4736, also known as durvalumab, is an investigational monoclonal antibody being studied for the treatment of several cancers, including non-small cell lung cancer, urothelial cancer, breast cancer, and recurrent or metastatic squamous cell carcinoma of the head and neck. It is currently in Phase 3 clinical development.
MEDI4736 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is an investigational monoclonal antibody in Phase 3 clinical trials for oncology indications.
MEDI4736 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of various cancers, including non-small cell lung cancer and head and neck cancer.
MEDI4736 has been studied in several clinical trials, including NCT02352948, a Phase 3 study in non-small cell lung cancer with 597 participants, and NCT02369874, a Phase 3 study in head and neck cancer with 736 participants. Both trials have been completed.
Yes, MEDI4736 is also known as durvalumab. The drug is being developed by AstraZeneca PLC under the ticker AZN and is currently in Phase 3 clinical trials for multiple oncology indications, including non-small cell lung cancer and urothelial cancer.