Retifanlimab is under clinical development by Incyte and currently in Phase II for Refractory Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Refractory Acute Myeloid Leukemia have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Retifanlimab’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.

Retifanlimab overview

Retifanlimab (Zynyz) is a humanized IgG4 kappa monoclonal antibody produced in Chinese hamster ovary cells. It is formulated as solution for intravenous route of administration. Zynyz is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Retifanlimab (MGA-012) is under development for the treatment of solid tumors including retroperitoneal sarcoma, newly-diagnosed glioblastoma multiforme, muscle-invasive urothelial carcinoma, well differentiated liposarcoma and dedifferentiated liposarcoma, advanced penile squamous cell carcinoma, recurrent and metastatic squamous cell carcinoma of the head and neck including oropharyngeal cancer, oral cavity cancer, hypopharynx cancer, and laryngeal cancer, metastatic melanoma, anal cancer, recurrent glioblastoma multiforme, metastatic non-small cell lung cancer, relapsed or refractory acute myeloid leukemia, metastatic urothelial cancer, metastatic renal cell carcinoma, cervical cancer, metastatic adenosquamous carcinoma of the pancreas, metastatic triple negative breast cancer, endometrial cancer, HER2 positive gastric cancer, gastroesophageal junction adenocarcinoma and soft tissue sarcoma. The therapeutic candidate is administered as an intravenous infusion. It is a monospecific, bivalent and it’s half life last from days to weeks. It is based on Fc Optimization platform technology. The therapeutic candidate acts by targeting Programmed Cell Death Protein 1. It was also under development for hematological malignancies, squamous carcinoma of the anal canal, esophageal squamous cell carcinoma and merkel cell carcinoma.

Incyte overview

Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, b-cell malignancies, solid tumors, non-small cell lung cancer, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

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

This content was updated on 2 September 2023

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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.