Johnson & Johnson Submits New Amivantamab (EGFR/cMET Bispecific Antibody) Indication for Approval in China
Johnson & Johnson
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On December 8, according to the CDE official website, Johnson & Johnson's Amivantamab new indication was submitted for marketing authorization in China (acceptance number: JXSS2300088). The speculated indication may be for the combination with chemotherapy to treat EGFR-mutated NSCLC patients with disease progression during or after osimertinib treatment.
AmivantamabSubmitted for marketing approval in China for the first time in October this year, and is currently under review.(Application No.: JXSS2300080)。
Source: CDE Official Website
Amivantamab is the world's first approved EGFR/cMET bispecific antibody, which received FDA approval in May 2021 based on Phase Ib clinical data for the treatment of EGFR exon 20 insertion mutation NSCLC that progressed after platinum-based chemotherapy.
On November 20, Johnson & Johnson announced that it had submitted a supplemental Biologics License Application (sBLA) to the FDA for the new indication of this drug, in combination with chemotherapy, to treat EGFR-mutated NSCLC patients whose disease has progressed during or after treatment with osimertinib.
Previously, Johnson & Johnson presented data from the MARIPOSA-2 and MARIPOSA Phase III clinical trials at the 2023 ESMO Congress, and recently disclosed the Asian subgroup analysis results of these two studies at the ESMO Asia meeting, which were consistent with the overall population outcomes.
MARIPOSA-2A Phase III trial of Amivantamab (Rybrevant) combined with lazertinib and chemotherapy for NSCLC patients after osimertinib resistance.Study Meets Dual Primary Endpoints, this is the first Phase III study to demonstrate a clinically meaningful improvement in PFS with osimertinib as a later-line treatment.
Results of the Asian subgroup analysis showed:
Among the 657 enrolled patients, 131 were randomly assigned to the Amivantamab plus chemotherapy group and 263 to the chemotherapy group, including 63 and 127 Asian patients, respectively.
At a median follow-up of 9.5 months, the risk of disease progression or death was reduced by 46% in the Amivantamab + chemotherapy group (HR=0.54; 95% CI: 0.37-0.81; P=0.002).Median PFS was 6.8 months (vs 4.2 months in the chemotherapy group), comparable to the overall population. ORR was 66% (vs 32% in the chemotherapy group); median intracranial PFS was 12.45 months (vs 8.5 months in the chemotherapy group).In terms of safety, the incidence of AE in Asian patients isTotalTarget PopulationSimilar.
MARIPOSA StudyIt shows that Amivantamab + Lazertinib significantly outperformed osimertinib as first-line treatment for EGFR-mutated advanced NSCLC, reducing the risk of disease progression or death by 30%, with benefits observed regardless of whether patients had brain metastases; DOR was extended by 9 months, and OS showed a favorable trend.
Results of the Asian subgroup analysis showed:
Among the 1,074 enrolled patients, 629 were Asian patients, randomly assigned to either the Amivantamab plus Lazertinib group (429 patients) or the Osimertinib group (429 patients), with 250 and 251 Asian patients, respectively. In the Asian patient population, the median age was 63 years, 61%/57% were female, and 44%/43% had a history of brain metastases.
At a median follow-up of 22.5 months,Amivantamab+Lazertinib Reduced the Risk of Disease Progression or Death by 35% in Asian Patients(HR=0.65; 95% CI: 0.50–0.83; P<0.001), with a median PFS of 27.5 months (vs 18.3 months in the osimertinib group), comparable to the overall population;ORR is 88%(95% CI: 84-92) (vs. osimertinib group 85%); the median DoR for patients with confirmed responses was 26.1 months (vs. osimertinib group 17.5 months).In terms of safety,Incidence of Adverse Events (AE) and TotalBodySimilar populations.
Development of EGFR/c-Met Antibody Drugs Led by Johnson & JohnsonAccording to the Insight database, there are 10 new drugs in clinical stages globally, of which 7 have entered clinical trials in China.
In China, MCLA-129, co-developed by Betta Pharmaceuticals and Merus, and EMB-01 from EpimAb Biotherapeutics are both EGFR/c-Met bispecific antibodies. Meanwhile, Genor Biopharma has developed a trispecific antibody, GB263T, targeting two distinct epitopes of EGFR and c-Met. Additionally, AstraZeneca has strategically developed an EGFR/c-Met dual-target ADC.
