Amivantamab is under clinical development by Johnson & Johnson and currently in the Phase I and Phase II 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 Amivantamab’s likelihood of approval (LoA) and phase transition for Hepatocellular Carcinoma took place on 14 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

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), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), metastatic colorectal cancer, esophageal 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).

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

Quick View Amivantamab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Amivantamab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Johnson & Johnson
  • Originator: Janssen Research & Development and Genmab
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.