Avelumab is under clinical development by Merck and currently in the Phase I, Phase II and Phase III 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 Avelumab’s likelihood of approval (LoA) and phase transition for Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis) took place on 06 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Avelumab overview

Avelumab (MSB-0010718C, Bavencio) is a programmed human IgG1 lambda monoclonal antibody. It is formulated as solution and concentrate solution for intravenous route of administration. Avelumab is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. It is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, in combination with axitinib is indicated  for the first-line  treatment of patients with advanced renal cell carcinoma (RCC), and for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

Avelumab (MSB-0010718C) is under development for the treatment of advanced or metastatic squamous anal cancer (SCCAC), adenocarcinoma of the gastro esophageal junction, gastric cancer, homologous-recombination deficient (HRD) ovarian cancer, diffuse large b-cell lymphoma, non-small cell lung cancer, bladder cancer, metastatic transitional cell carcinoma of the urothelium including the bladder, urethra, renal pelvis, and ureter, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, head and neck cancer squamous cell carcinoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, TNBC, squamous non-small cell lung cancer, colorectal cancer, neuroendocrine carcinoma, renal pelvis cancer, upper urinary tract cancer and bladder cancer, urethral cancer, progressing tenosynovial giant cell tumor/pigmented villonodular synovitis,  follicular lymphoma, hepatocellular carcinoma, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, muscle invasive bladder cancer (MIBC), recurrent head and neck cancer squamous cell carcinoma, endometrial cancer, peripheral t-cell lymphomas (PTCL),anaplastic large cell lymphoma (ALCL),natural killer cell lymphomas, transformed mycosis fungoides, angioimmunoblastic t-cell lymphoma (AITL)/immunoblastic lymphadenopathy, angiosarcoma, glioblastoma (GBM),small-cell lung cancer, osteosarcoma, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, malignant mesothelioma, hepatobiliary system tumor, adrenocortical carcinoma (adrenal cortex cancer), head and neck cancer squamous cell carcinoma, pancreatic cancer, mantle cell lymphoma, meningioma, squamous cell carcinoma, penile cancer and precancerous condition. It was also under development for the treatment of neuroendocrine gastroenteropancreatic tumors (GEP-NET), neuroendocrine tumors, renal cell carcinoma, Hodgkin lymphoma (B-Cell Hodgkin lymphoma), gastric cancer, melanoma, adenocarcinoma of the gastroesophageal junction (third-line therapy), epithelial ovarian cancer (first line therapy, second-line therapy),fallopian tube cancer, peritoneal cancer, non-small cell lung cancer (second line therapy), cervical cancer, Merkel cell carcinomax, nasopharyngeal cancer, leiomyosarcoma, pancreatic ductal adenocarcinoma, relapsed /refractory multiple myeloma, colon cancer, central nervous system tumor, glioma and head and neck cancer.

Merck overview

Merck, a subsidiary of E. Merck KG, is a science and technology company. It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials. Merck also provides a wide range of products including lab water systems, gene editing tools, cell lines, antibodies and end-to-end systems. The company serves healthcare, performance materials, and life sciences markets. It has presence in Europe, North America, Asia-Pacific, Latin America and Middle East and Africa. Merck is headquartered in Darmstadt, Hesse, Germany.

Quick View Avelumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Avelumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Musculoskeletal Disorders
  • Non Malignant Disorders
  • 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.