The Janssen Pharmaceutical Companies of
The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.[1] The Company has also established an expanded access program (EAP) [NCT04599712][2] for patients in the
Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.[3],[4],[5],[6] In
'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,' said
The BLA submission for amivantamab is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI)[8], in adult patients with advanced NSCLC.[9] In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.8,[10] Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the
'Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at
EGFR mutations, leading to uncontrolled cancer cell growth and division[11], are some of the most common mutations in NSCLC.[12] EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.13 However, EGFR exon 20 insertion mutations are also often undetected.[13] Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertion mutations and broader use of NGS can help to detect these mutations.[14] Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and, in addition, carries a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.[15] Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months[16], which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months.[17]
In 2018, Janssen entered into a license and collaboration agreement with
RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same, or get bigger.
About Amivantamab
Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.3,4,5,6 Amivantamab is pending regulatory review as a potential treatment for patients with NSCLC with EGFR exon 20 insertion mutations whose tumors typically do not respond to current standard of care. Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab. The production and development of the antibody followed
About the Amivantamab Expanded Access Program Protocol (EAP)
The amivantamab EAP is for
About Non-Small Cell
Worldwide, lung cancer is the most common cancer, and NSCLC makes up 80 to 85 percent of all lung cancers.[18],[19] The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cellcarcinoma.19 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.11 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.[20] The five-year survival rate for all patients with metastatic NSCLC with EGFR mutations treated with EGFR TKIs is less than 20 percent.[21],[22] Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.11
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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