Janssen Announces China Approval of Rybrevant® (Amivantamab Injection) in Combination with Chemotherapy for EGFR-Mutated NSCLC

MARIPOSA-2 Phase III Study Shows Amivantamab Plus Chemotherapy Significantly Improves Median PFS Compared to Chemotherapy Alone, Reducing the Risk of Disease Progression or Death by 52%. The Asian Subgroup Data Indicates an Investigator-Assessed Median PFS of 10.3 Months in the Asian Population.
On April 25, 2025, Johnson & Johnson announced that its innovative therapeutic drug Rikewei (Amivantamab Injection) has officially received approval from the National Medical Products Administration (NMPA) for use in combination with carboplatin and pemetrexed to treat adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who carry epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations and whose disease has progressed during or after treatment with EGFR tyrosine kinase inhibitors. This approval marks the second lung cancer indication for Amivantamab in China this year. Previously, Rikewei was approved in February this year as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

This approval is based on the robust efficacy and safety data from the MARIPOSA-2 Phase III study. The results demonstrated that, compared to chemotherapy alone, amivantamab combined with chemotherapy reduced the risk of disease progression or death by 52%, with a median progression-free survival (PFS) of 6.3 months, compared to 4.2 months in the chemotherapy-alone group (HR=0.48; 95% CI: 0.36–0.64; P<0.001). The study also observed that, in the Asian subgroup population of MARIPOSA-2, investigator-assessed median PFS was 10.3 months with amivantamab plus chemotherapy versus 4.2 months with chemotherapy alone (HR=0.39; 95% CI: 0.26–0.59; P<0.0001). Notably, based on the results of the MARIPOSA-2 clinical trial, the National Comprehensive Cancer Network's (NCCN) Clinical Practice Guidelines recommend amivantamab in combination with chemotherapy as the sole Category 1 preferred treatment option for patients with advanced NSCLC harboring classic EGFR mutations who have progressed after osimertinib treatment.

Lung cancer ranks first in both incidence and mortality among all malignant tumors in China. According to statistics, there are over 1 million new cases of lung cancer annually in China, accounting for more than one-third of the total number of lung cancer patients worldwide. The EGFR gene mutation is the most common driver gene in non-small cell lung cancer (NSCLC), with approximately 40% of patients in China carrying this mutation type. There are various classic EGFR mutation types, among which exon 19 deletions and exon 21 L858R point mutations are the most common EGFR mutations. Statistics show that the 5-year survival rate of EGFR-mutant advanced non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20%. The mechanisms of acquired resistance following previous treatment with EGFR TKI monotherapy are diverse and polyclonal. This makes targeted therapy after disease progression more challenging, thus limiting the efficacy of targeted treatments. Additionally, combining chemotherapy with immunotherapy has not demonstrated clinically meaningful improvements. Therefore, the emergence of the amivantamab plus chemotherapy regimen provides an important new treatment option for EGFR-mutant non-small cell lung cancer patients whose disease has progressed after EGFR TKI therapy.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated: "The approval of RYKIN's new indication represents a breakthrough innovative treatment option for patients with classic EGFR mutations who have been treated with EGFR TKIs. It effectively addresses the unmet clinical needs of these patients with significant clinical advantages and serves a broader population of non-small cell lung cancer patients with EGFR mutations through the expansion of the new indication, driving the industry into a new era of bispecific antibody therapy. As Johnson & Johnson Innovative Medicine celebrates its 40th anniversary in China, we are committed to continuing collaboration with multiple stakeholders to meet the comprehensive needs of patients from treatment to social support by providing innovative solutions. We aim to accelerate the establishment of a patient-centered healthcare ecosystem, helping more patients return to normal lives."

The safety profile of evolocumab combined with chemotherapy is consistent with the previously reported safety profile of monotherapy, with 10% of patients discontinuing treatment due to treatment-related adverse reactions.