Janssen Pharmaceutical Firms of Johnson & Johnson introduced the submission of a biologics license utility (BLA) searching for FDA approval of amivantamab for the therapy of metastatic non small-cell lung most cancers (NSCLC) sufferers with epidermal development issue receptor (EGFR) exon 20 insertion mutations with illness development whereas on or after therapy with platinum-based chemotherapy.1
Amivantamab, a fully-human EGFR and mesenchymal epithelial transition issue (MET) bispecific antibody with immune cell-directing exercise, targets tumors with activating and resistance EGFR and MET mutations and amplifications. The investigational drug obtained breakthrough remedy designation from the FDA for the indicated affected person inhabitants in March, and this BLA submission is the primary regulatory submission for the therapy of NSCLC with EGFR exon 20 insertion mutations.
EGFR mutations are a few of the commonest in NSCLC, and EGFR exon 20 insertion mutations are the third commonest major EGFR mutation. They typically go undetected, however broader use of subsequent era sequencing might assist determine extra sufferers with EGFR exon 20 insertion mutations.
“This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options,” Peter Lebowitz, MD, PhD; world therapeutic space head, oncology, Janssen Analysis & Improvement, LLC; stated in an announcement. “We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs.”
The submission for approval relies on early leads to the monotherapy arm of the Part I CHRYSALIS examine (NCT02609776), a multi-center, open-label, multi-cohort examine of amivantamab’s security and efficacy in superior NSCLC sufferers each as a monotherapy and together with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI).
The information, which have been introduced a poster presentation on the American Society of Scientific Oncology (ASCO) Digital Scientific Program in May, discovered that sufferers within the monotherapy cohort noticed a 36% general response price, and sufferers who had beforehand undergone platinum-based chemotherapy noticed a 41% response price.2
Knowledge from the Part I trial additionally help the institution of an expanded entry program (NCT04599712) that makes some sufferers eligible for amivantamab therapy forward of the approval whereas the FDA opinions the BLA.
“Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at Johnson & Johnson are committed to improving outcomes for patients diagnosed with this complex, deadly disease. With today’s submission for amivantamab, we are one step closer to that goal,” Mathai Mammen, MD, PhD; world head, Janssen Analysis & Improvement, Johnson & Johnson, stated. “We are steadfast in our focus to advance novel therapeutics and medicines that will transform the trajectory of some of the most challenging and deadly diseases of our time, including lung cancer.”
1. Janssen Submits Utility to U.S. FDA Searching for Approval of Amivantamab for the Therapy of Sufferers with Metastatic Non-Small Cell Lung Most cancers with EGFR Exon 20 Insertion Mutations. Information launch. Janssen Pharmaceutical Firms of Johnson & Johnson; December 3, 2020. Accessed December 4, 2020. https://www.janssen.com/janssen-submits-application-us-fda-seeking-approval-amivantamab-treatment-patients-metastatic-non
2. Janssen Proclaims Part 1 Outcomes for Bispecific Antibody Amivantamab within the Therapy of Sufferers with Superior Non-Small Cell Lung Most cancers Harboring Exon 20 Insertion Mutations. Information launch. Janssen Pharmaceutical Firms of Johnson & Johnson; May 18, 2020. Accessed December 4, 2020. https://www.janssen.com/janssen-announces-phase-1-results-bispecific-antibody-amivantamab-treatment-patients-advanced-non