Avelumab is under clinical development by Merck and currently in Phase II for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Relapsed Acute Myeloid Leukemia have a 20% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Avelumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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), metastatic non-squamous non-small cell lung cancer, 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, 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, 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, progressing tenosynovial giant cell tumor/pigmented villonodular synovitis, melanoma, 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, microbiology and biomonitoring products, test assays, analytical reagents, and flow cytometry kits and instruments and end-to-end systems. The company serves healthcare, performance materials, and life sciences markets. It has a presence in Europe, North America, Asia-Pacific, Latin America and Middle East and Africa. Merck is headquartered in Darmstadt, Hesse, Germany.

For a complete picture of Avelumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.