Johnson and Johnson Amivantamab Dual Anti-Domestic Start-Up Phase III Clinical has submitted BLA to the FDA

From: Insight Database () from: CDE official website Amivantamab (research and development code: JNJ-61186372) is johnson and Johnson developed EGFR/c-Met dual resistance, in March this year, the drug was certified by the FDA breakthrough therapy;
Lazertinib, a third-generation EGFR small molecule inhibitor developed by Johnson and Johnson, is currently at its highest level in the country to Phase I clinically.
prior to this Phase III clinical launch, Johnson and Johnson conducted Phase 1 clinical trials in 2019 on safety, PK, Exploratory Phase 2 recommended doses, and initial efficacy in patients with advanced non-small cell lung cancer.
from: Insight Database () CTR20202472 is a parallel, random, double-blind international multi-center Phase III clinical, international target group of 1000 people, domestic target group of 200 people, carried out in 35 hospitals in China, the main researcher is the Director of Shanghai Chest Hospital Lu Wei.
have not yet recruited patients.
The main purpose of this trial was to assess the efficacy of amivantamab and Lazertinib in patients with local late stage or metastasis NSCLC who were positive for the EGFR mutation (exon 19 missing or exon L858R replacement).
endpoint indicators for this trial are progress-free lifetime (PFS, expected to reach 42 months), secondary endpoint indicators include total lifetime (OS, expected to be 60 months), objective mitigation rate (ORR), mitigation duration (DOR), and so on.
addition, according to the Insight database, Johnson and Johnson registered six Amivantamab clinical trials at ClinicalTrials.gov, including two Phase III clinical trials, and in addition to taking drugs with Lazertinib, Johnson and Johnson explored Amivantamab's joint treatment with Capra/Pemite to treat NSCLC patients inserted by EGFR 20 exons.
: Insight Database () At the 2020 ASCO Conference, Johnson and Johnson published the results of the CHRYSALIS Study I (NCT02609776).
data show that in patients with advanced NSCLC with EGFR exon 20 insertion mutations, Amivantamab treatment showed lasting remission: 36% total remission rate (ORR) and 1 median remission duration (DOR) in all assessable patients The 0-month, clinical benefit rate (≥ partial remission of the disease stabilization ≥12 weeks) was 67%, or in previously assessable patients receiving platinum-containing chemotherapy, the ORR was 41%, the medium DOR was 7 months, and the clinical benefit rate was 72%.
note that there are currently no FDA-approved drugs for EGFR exon 20 mutations, and Amivantamab is the first treatment for such patients.
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