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, in combination with lazertinib for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test, also indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).

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), glioblastoma multiforme, 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.

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.