Johnson and Johnson EGFR-MET dual resistance and third-generation EGFR-TKI combination therapy were approved for 4 clinical trials in China.

According to the latest announcement today by the Drug Review Center (CDE) of the State Drug Administration of China, the combination therapy of the EGFR-MET dual anti-drug amivantamab injection and the third generation of the EGFR-TKI drug lazertinib tablets by Johnson and Johnson has obtained four clinical trials with implied approvals for the adaptation of amivantamab injections/lazertin. Ib tablets are used in the treatment of EGFR 19 exon loss or L858R activation mutations, and in patients with first- or second-generation TKI for first-line therapy or for disease progression in patients with disease progression after first- or second-line treatment with third-generation TKI (e.g. oxytinib).
amivantamab injection/lazertinib tablet combination drug for the treatment of NSCLC patients with EGFR 19 exon loss or L858R activation mutations, treated with oghitinib or other approved third-generation EGFR TKI, and progression of the disease after platinum-containing dual-drug chemotherapy.
it is worth mentioning that both of these drugs are in research and development by Johnson and Johnson through licensing and partner development, and have now become the company's key research and development projects in the field of cancer research and development.
of these, Amivantamab, was awarded a breakthrough treatment by the FDA in March, and Lazertinib was introduced by Johnson and Johnson's Janssen for more than $1.25 billion in 2018.
Photo Source: CDE Screenshot Amivantamab (code: JNJ-6372) is a dual-specific antibody that targets EGFR and MET, which not only blocks ligand binding to EGFR and MET, promotes the degradation of the subject, but also triggers antibody-dependent cytotoxicity.
antibody was developed by Jansen and Genmab using Genmab's DuoBody technology platform.
, the FDA awarded the drug Breakthrough Therapy for the treatment of metastasis NSCLC patients with EGFR exon 20 insertion mutations.
that clinical trials of the innovative therapy in this area have been positive results and are expected to submit regulatory applications in the United States by the end of the year.
Lazertinib is an efficient, oral, irreversible third-generation tyrosine kinase inhibitor (TKI) that is being developed for the treatment of NSCLC patients with EGFR gene mutations.
is known to be highly specific to EGFR, which carries specific activation gene mutations, and can cross the blood-brain barrier.
2018, Johnson and Johnson's Janssen acquired exclusive rights to the drug worldwide, excluding South Korea, for an advance of $50 million and a development and promotion milestone payment that is expected to be as high as $1.205 billion.
phase 1/2 clinical trial presented at the 2018 ASCO Conference showed that lazertinib was able to achieve an objective remission rate (ORR) of 61% in NSCLC patients who were already resistant to EGFR-TKI, and 55% of intracranial ORR in patients with brain metastasis tumors.
we all know that lung cancer is the number one cancer.
NSCLC accounts for about 85% of lung cancer cases.
about 75% of NSCLC patients diagnosed with late stages, with a five-year survival rate of only 5%.
public data show that EGFR mutations occur in 10% to 35% of NSCLC worldwide, and about 50% of NSCLC patients in China have EGFR gene mutations.
this is why many of the world's targeted drugs for lung cancer have been developed to try to suppress cancer by inhibiting the activity of the mutant EGFR.
from the first to the third generation, several tyrosine kinase inhibitors (TKI) drugs for EGFR have been introduced in the past, bringing clinical improvements to many patients.
, however, access to the drug in patients treated with TKI has allowed the disease to continue to progress.
in response to drug resistance in patient treatment, scientists in the drug development community are working to develop new drugs, including the dual anti-drug amivantamab, which Johnson and Johnson is jointly developing, and the third-generation EGFR TKI drug lazertinib.
that the combination therapy of the two drugs was approved clinically in China is another advance in their clinical development process.
note that in July this year, Johnson and Johnson registered a phase 3 clinical study of the first-line treatment of locally advanced or metastasis non-small cell lung cancer of EGFR mutations in Amivantamab joint lazertinib at ClinicalTrials.gov. To evaluate the efficacy and safety of the combination therapy compared to osexitinib or single-drug first-line treatment of EGFR mutations (exon 19 missing or exon 21 L858R replacement), local late stage or metastasis non-small cell lung cancer.
, according to public information, the study plans to include 1,000 subjects and will officially launch patient recruitment in October this year.
that the combination therapy of the amivantamab injection and lazertinib tablets has been approved clinically in China, meaning that the combined therapy will soon be conducted in China.
we congratulate Johnson and Johnson and hope that these studies will be carried out smoothly and bring new hope for treatment to patients at an early time.
: The Drug Review Center of the State Drug Administration of China. Retrieved Sep 15,2020, from. #