Janssen Announces China Approval of Rybrevant® (Amivantamab) in Combination with Lazcluze® (Lazertinib) for First-Line Treatment of EGFR Exon 19 Del or L858R-Mutated Advanced NSCLC

China Finance Network August 8th: Johnson & Johnson announced today that its innovative therapeutic drug Riqiu (Amivantamab Injection) has been officially approved by the National Medical Products Administration (NMPA), in combination with Liqiu (Lazertinib Mesylate Tablets), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

This approval marks the third lung cancer indication for Amivantamab in China this year. Previously, Rybrevant was approved as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations, as well as for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with classical EGFR mutations whose disease has progressed during or after EGFR TKI therapy. This chemotherapy-free regimen significantly extends overall survival compared to Osimertinib, with the median survival not yet reached, and an expected extension of more than one year.

Amivantamab is a bispecific antibody that simultaneously targets EGFR and MET. It can inhibit both the EGFR and MET pathways, degrade EGFR and MET receptors, and possesses immune cell-directed activity. The synergistic action of these three mechanisms effectively suppresses and kills tumor cells. Lazertinib is a third-generation EGFR tyrosine kinase inhibitor (TKI). Studies have confirmed that the combination of amivantamab and lazertinib can improve disease progression in patients with EGFR-mutated advanced non-small cell lung cancer and effectively reduce the complexity and heterogeneity of acquired resistance mechanisms.

This approval is based on the results of the Phase III MARIPOSA trial, which aimed to evaluate the efficacy and safety of amivantamab in combination with lazertinib compared to osimertinib monotherapy as a first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR classical mutations. The study results showed that, compared to osimertinib, the combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30%, with a median progression-free survival (PFS) of 23.7 months, versus 16.6 months in the osimertinib group (HR= 0.70 [95% CI: 0.58, 0.85]; P-value <0.001).

The study also observed that, in the MARIPOSA Asian subgroup population, compared with Osimertinib, the combination of Amivantamab and Lazertinib reduced the risk of disease progression or death by 35%. After a median follow-up of 22.5 months, the median PFS for the Amivantamab plus Lazertinib group and the Osimertinib group were 27.5 months and 18.3 months, respectively (HR=0.65; nominal P value<0.001). In terms of secondary endpoints, compared with Osimertinib, the combination of Amivantamab and Lazertinib extended the median duration of response (DoR) by 9 months (25.8 months vs 16.8 months).

Final Prespecified Overall Survival (OS) Analysis of the MARIPOSA Study Presented at the 2025 European Lung Cancer Conference (ELCC) Demonstrates that Amivantamab Plus Lazertinib Significantly Extends OS in First-Line Treatment of Adult Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations. After a Median Follow-Up of 37.8 Months, the Chemotherapy-Free Combination of Amivantamab Plus Lazertinib Showed Statistically and Clinically Significant Improvement in OS Compared to Osimertinib; The Median OS for Amivantamab Plus Lazertinib Was Not Reached ([NR]; 95% CI, 42.9-NR), With an Estimated Median Survival Prolongation of More Than One Year (HR 0.75; 95% CI, 0.61-0.92; P<0.005). Three and a Half Years Post-Treatment, 56% of Patients in the Amivantamab Plus Lazertinib Group Were Still Alive, Compared to Only 44% in the Osimertinib Group.

Notably, progression-free survival (PFS) mainly measures the time from the start of treatment to disease progression, while overall survival (OS) better helps patients understand the potential real benefits of the treatment in extending life.

In terms of safety, the safety data of Amivantamab combined with Lazertinib is consistent with previous reports. Adverse events are mostly grade 1-2 and mainly occurred within the first four months. No new safety signals were found during long-term follow-up.

Lung cancer is the most common malignant tumor in China, with its incidence and mortality rates ranking first among malignant tumors. Non-small cell lung cancer accounts for 80%-85% of all lung cancer cases. Among patients with EGFR mutation-positive advanced non-small cell lung cancer, 25%-39% cannot continue to receive second-line treatment due to disease progression.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated that the combination of Amivantamab and Lazertinib has demonstrated outstanding clinical efficacy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR classical mutations. This not only addresses the unmet clinical needs of these patients but also establishes a new standard for first-line treatment of EGFR-mutated non-small cell lung cancer in China. "We are very excited to bring this breakthrough innovative solution to Chinese patients. As Johnson & Johnson Innovative Medicine celebrates its 40th anniversary in China, we are committed to further advancing in the field of oncology, effectively helping to reduce the heavy disease burden of lung cancer, which is the leading threat to the health of the Chinese people. We will accelerate the prevention, diagnosis, treatment, and cure of complex diseases, ushering in a new era of medical treatment for the industry."