Johnson and Johnson EGFR/c-Met dual resistance to market application with Phase I data

EGFR mutations are common genetic mutations in patients with non-small cell lung cancer, accounting for about 10% to 15%, and in Asian populations, this number is about 40% to 50%.
EGFR exon 20 insertion mutation accounts for about 9% of all EGFR mutation non-small cell lung cancer patients.
patients with EGFR exon 20 insertion mutations in non-small cell lung cancer are generally insensitive to EGFR-TKI treatment and have a worse prognostic period than patients with more common EGFR mutations (exon 19 missing/L858R replacement).
, the standard treatment for such patients is conventional cytotoxic drug chemotherapy.
fda has not yet approved targeted therapies specifically for patients with EGFR exon 20 insertion mutation NSCLC, amivantamab is the first drug to be marketed to regulators for treatment of such patients.
, Johnson and Johnson also launched the Expanded Access Program (EAP).
eligible patients in the U.S. are likely to receive the drug while amvantamab is being approved by the FDA.
Amivantamab is a dual-specific antibody that targets EGFR drug-resistant mutations, MET mutations, and amplification, binding both EGFR and c-Met's extracellular structures, blocking the binding of the mating to EGFR and MET, promoting the degradation of the subject, and triggering antibody-dependent cytotoxicity.
Johnson and Johnson's application for listing is based on data from the I-Phase I CHRYSALIS study on the single-drug therapy queue.
CHRYSALIS study was a multi-center, open-label, multi-queue trial that evaluated the efficacy and safety data of amivantamab monodrides and a combined lazertinib (EGFR T790M inhibitor) for the treatment of advanced NSCLC in adults.
early data on the insertion of EGFR exons 20 into the queue of patients with the mutant NSCLC were presented at the ASCO2020 conference.
data showed that all 39 patients with ORR were 36%, with a medium duration of 10 months and a medium PFS of 8.3 months, patients who had previously received platinum-containing chemotherapy had ORR of 41% (12/29), a medium DOR of 7 months and a medium PFS of 8.6 months.
: ASCO2020 At the ESMO2020 Conference, Johnson and Johnson released data on the efficacy of the amivantamab joint oral lazertinib.
in 20 patients who were treated for the first time, the objective remission rate was 100% at 7 months.
in 45 patients who were drug-resistant and had not received chemotherapy, the objective remission rate of combination therapy reached 36%, including 1 patient who was fully remission and 15 patients who were partially relieved.
September 23, Amivantamab applied for implied approval in two clinical trials in China: 1) joint treatment of EGFR 19 exon loss or L858R activation mutation, local late stage or progressive NSCLC patients without previous treatment; Patients with missing or L858R-activated mutations who have progressed after first-generation (e.g., erotinib, gyfeitinib, etc.) or second-generation (e.g., afatinib, daktinib, etc.) TKI for first-line treatment or third-generation TKI (e.g., oseltinib) for first- or second-line treatment.
October 17, amivantamab was also awarded a breakthrough therapy qualification in China by CDE for the treatment of patients with platinum-containing bidal chemotherapy who progressed during or after chemotherapy, or who had a metastasis or surgically unseistable non-small cell lung cancer that was impatient with the carrier skin growth factor tolerance (EGFR) 20 exon 20.
is currently studying EGFR/c-Met dual resistance Worldwide Source: NextPharma There are currently 8 EGFR/c-Met dual resistances worldwide.
fastest-growing domestic enterprises is EMB-01, which was released at the AACR conference in June this year.
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