Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. According to GlobalData, Phase I drugs for Gastroesophageal (GE) Junction Carcinomas have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
Amivantamab overview
Amivantamab-vmjw (Rybrevant) is a low-fucose human immunoglobulin G1-based bispecific antibody developed using recombinant DNA technology. It is formulated as solution and concentrate for solution for intravenous infusion. Amivantamab is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Amivantamab is under development for the treatment of non-small-cell lung cancer (NSCLC), recurrent squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), metastatic colorectal cancer, renal cell cancer (RCC), medullary thyroid cancer (MTC), gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). It is administered as an intravenous and subcutaneous infusion. The drug candidate is a bi-specific monoclonal antibody that targets EGFr and cMet with exon-20 insertion. It is based on DuoBody technology platform. The drug candidate is a new molecular entity (NME).
It was under development for gastroesophageal cancer (GEC), esophageal cancer, and gastric cancer.
Johnson & Johnson overview
Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products and medical devices. The company conducts business through its operating companies. It provides pharmaceuticals for immune disorders, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; and medical devices for use in cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, healthcare professionals and hospitals. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US) and Latin America. J&J is headquartered in New Brunswick, New Jersey, the US.
For a complete picture of Amivantamab’s drug-specific PTSR and LoA scores, buy the report here.
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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 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.
