Amivantamab by Johnson & Johnson for Colorectal Cancer: Likelihood of Approval

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% 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.

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), 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.

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