Durvalumab is under clinical development by AstraZeneca and currently in the Phase I, Phase II, Phase III and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Durvalumab’s likelihood of approval (LoA) and phase transition for Epithelial Ovarian Cancer took place on 28 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Durvalumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Durvalumab overview

Durvalumab (MEDI-4736, Imfinzi, Fidursi, Imfinzio) a programmed death-ligand 1 (PD-L1) blocking antibody. It is formulated as solution and concentrate solution for intravenous route of administration. Imfinzi is indicated as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC). and for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide), and adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.

It is under development for the treatment of advanced or metastatic papillary renal cell carcinoma, poorly differentiated thyroid carcinoma, anaplastic thyroid cancer, follicular thyroid cancer, medullary thyroid cancer and papillary thyroid cancer, HER2 negative metastatic breast cancer, esophageal squamous cell carcinoma, secondary central nervous system lymphoma and secondary diffuse large B-cell lymphoma (DLBCL), pulmonary sarcomatoid carcinoma, bile duct cancer, non-small cell lung cancer, metastatic colorectal cancer, glioblastoma multiforme, recurrent head and neck cancer squamous cell carcinoma, esophageal squamous cell carcinoma (ESCC), head and neck cancer squamous cell carcinoma, hepatocellular carcinoma, metastatic biliary tract cancer, esophageal cancer, Epstein-Barr virus positive (EBV+) nasopharyngeal carcinoma, adenocarcinoma of the gastro-esophageal junction, renal cell carcinoma, ovarian cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, muscle invasive bladder cancer (MIBC), mycosis fungoides, sezary syndrome, malignant pleural mesothelioma, myelodysplastic syndrome, small-cell lung cancer, non-muscle invasive bladder cancer (NMIBC) (superficial bladder cancer), endometrial cancer, diffuse large b-cell lymphoma, primary mediastinal B-cell lymphoma, follicular thyroid cancer, oropharyngeal cancer, human papillomavirus (HPV) associated cancer, t-cell lymphomas, primary mediastinal b-cell lymphoma, germ cell tumors, soft tissue sarcoma, transitional cell carcinoma (urothelial cell carcinoma), b-cell chronic lymphocytic leukemia, lymphoma, refractory multiple myeloma, relapsed multiple myeloma, B-cell non-Hodgkin lymphoma, breast cancer, triple-negative breast cancer, endometrial cancer, hormone-sensitive prostate cancer, esophageal cancer, primary CNS lymphoma, anaplastic large cell lymphoma, small-cell lung cancer, malignant pleural mesothelioma, fallopian tube cancer, peritoneal cancer, oropharyngeal cancer, metastatic breast cancer, ovarian cancer, metastatic adenocarcinoma of the pancreas, vulvar cancer, vaginal cancer, human papillomavirus (HPV) associated cancer, gastric cancer, pancreatic ductal adenocarcinoma, esophageal cancer, melanoma, oral cavity (mouth) cancer, leiomyosarcoma, gallbladder cancer, metastatic melanoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, metastatic biliary tract cancer, papillary renal cell carcinoma, metastatic renal cell carcinoma, transitional cell carcinoma (urothelial cell carcinoma), angiosarcoma, dedifferentiated liposarcoma, osteosarcoma, bladder carcinoma, ureter cancer, urethral cancer, chronic lymphocytic leukemia (CLL).

It was also under development for metastatic cervical cancer, neuroendocrine tumor, multiple myeloma (Kahler disease) as firstline therapy, relapsed and refractory multiple myeloma, diffuse large B-cell lymphoma, peripheral T-cell lymphomas (PTCL), Post-Polycythemia Vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (POST-ET MF), primary myelofibrosis, B-cell chronic lymphocytic leukemia, lymphoma and recurrent head and neck cancer squamous cell carcinoma (first line therapy) and unspecified cancer.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

Quick View Durvalumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Durvalumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.