Johnson amivantamab EU application for listing: treatment of EGFR exoded...

Johnson and Johnson (JNJ) Janssen Pharmaceuticals recently announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for Amivantamab (JNJ-61186372, JNJ -6372), used to treat patients with metastasis non-small cell lung cancer (NSCLC) with insertion mutations in exons No. 20 of the skin growth factor acceptor (EGFR) gene after failure to undergo platinum-containing chemotherapy.
month, Janssen Pharmaceuticals also filed a biopharmaceutical licensing application (BLA) with the U.S. Food and Drug Administration (FDA).
noted that this marks the first regulatory filing by the European Union and the United States for the treatment of NSCLC patients with EGFR exon 20 insertion mutations.
approved, amivantamab would be the first therapy specifically targeting EGFR exon 20 insertion mutation NSCLC.
amivantamab is an all-human EGFR-interstital dermistic transformation factor (MET) dual-specific antibody in the study, with immune cell-oriented activity, targeting tumors carrying activated and drug-resistant EGFR and MET mutations and amplification.
production and development of Amivantamab follows a licensing agreement between Jansen Biotech and Genmab for the use of the DuoBody technology platform.
Amivantamab BLA and MAA, both based on the results of the Issue I CHRYSALIS Study (NCT02609776).
data show that in patients with advanced NSCLC with EGFR exon 20 insertion mutations, amivantamab treatment showed lasting remission: (1) total remission rate (ORR) was 36% in all assessable patients and median remission duration (DOR) was 1 0 months, clinical benefit rate (≥ partial remission of disease stabilization ≥12 weeks) was 67% ;(2) In previously assessable patients receiving platinum-containing chemotherapy, ORR was 41%, the mesodor was 7 months, and the clinical benefit rate was 72%.
In March, the FDA granted amivantamab breakthrough drug eligibility (BTD) to treat patients with metastasis NSCLC who developed the condition after receiving platinum-containing chemotherapy, EGFR No. 20 exons with insertion mutations, according to ORR and DOR data from the CHRYSALIS study.
Peter Lebowitz, M.D., Global Therapeutics, Jansen Research and Development, said,
The EU MAA submission is an important milestone in our commitment to developing innovative targeted therapies for lung cancer patients.
this is an important step towards this goal, to improve the prognostic prognostics of patients with EGFR exon 20 insertion mutation NSCLC, which currently do not have approved targeted therapies.
, lung cancer is the most common type of cancer, with non-small cell lung cancer (NSCLC) accounting for 80-85% of all lung cancers.
subsypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
most common drive mutation in NSCLC is a change in the EGFR gene, a subject of tyrosine kinase that helps cells grow and divide.
EGFR mutations were found in 10%-15% of NSCLC patients and 40%-50% of Asian NSCLC adenocarcinoma patients.
EGFR No. 20 exon insertion mutation is a unique sub-group of lung adenocarcinoma, accounting for at least 9% of all EGFR mutations.
currently, the five-year survival rate for patients with metastasis NSCLC is only 6%.
NSCLC patients with insertion mutations in EGFR No. 20 exons are generally insensitive to the treatment of approved GFR subject tyrosine kinase inhibitors (TKI) and have a worse prognosis than in patients with more common EGFR mutations (exon 19 absence/L858R replacement).
Currently, for lung cancer patients with insertion mutations in EGFR No. 20 exons, the estimated total survival time (OS) is 16 months, and the clinical standard treatment is conventional cytotoxic chemotherapy, with no approved targeted therapy.
the mechanism of action of amivantamab (photo source document - doi-10.1158/2159-8290.CD-20-0116) CHRYSALIS A first human body Open label, multi-center Phase I studies are evaluating the safety, pharmacological dynamics, and efficacy of amivantamab as a single drug therapy, as well as in combination with the new third-generation EGFR-TKI drug lazertinib, to treat adult patients with advanced NSCLC.
the study, 50 patients with EGFR No. 20 exon insertion mutations received the recommended phase II dose (RP2D: 1050 mg, weight ≥80 kg patients 1400 mg) amivantamab treatment.
of these 50 patients, 39 were assessed for remission and received ≥2 disease assessments, 29 of which had previously received platinum-containing chemotherapy.
13 different EGFR exon 20 insertion mutations were found in 39 patients.
data show that the total observed mitigation rate (ORR) was 36% (95% CI:21-53) in all assessable patients and 41% (95% CI:24-61) in patients who had previously received platinum-containing chemotherapy.
addition, the medium duration of remission (DoR) was 10 months in all 14 remission patients and 7 months in patients who had previously received remission with platinum-containing chemotherapy.
In all patients, the medium non-progression lifetime (PFS) was 8.3 months (95% CI: 3.0-14.8) and in patients who had previously received platinum-containing chemotherapy, the medium PFS was 8.6 months (95% CI:3.7-14.8).
In all patients, the clinical benefit rate (≥ partial remission (PR) or disease stabilization ≥11 weeks) was 67% (95% CI:50-81) and in patients who had previously received platinum-containing chemotherapy, the clinical benefit rate was 72% (95% CI:53-87).
were observed in patients who had previously received treatment and had previously received platinum-containing chemotherapy.
tumor response is most common in the first disease assessment after initiating treatment.
study, the most common adverse events (AEs) at all levels were rashes, infusion-related reactions (IRR), and methicilitis.
IRR occurs primarily in the first infusion and does not interfere with subsequent infusion therapy.
no ≥ level 3 rash was reported in 1 patient with level 3 diarrhea (6% of patients had any level of diarrhea).
6% of patients developed treatment≥-related level 3 AE, including high amylaseemia, hypokalemia, lipase elevation, and shoulder/chest pain.
6% of patients reported serious adverse events associated with treatment, such as cellulitis, interstitiotic lung disease, and shoulder/chest pain.
original source: Janssen Submits European Marketing Authorisation application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung With EGFR Exon 20 Insertion Mutations This article was originally published from Bio Valley, for more information please download Bio Valley APP (