Janssen's Amivantamab Receives NMPA Approval in China for New Indication in EGFR-Mutated NSCLC

On April 25, Johnson & Johnson announced its innovative therapeutic drugRui Ke® (Amivantamab Injection)Officially approved by China NMPA, administered in combination with carboplatin and pemetrexed, applicable for the treatment of patients with epidermal growth factor receptor（EGFR）Deletion in exon 19 or L858R substitution mutation in exon 21 with disease progression during or after EGFR tyrosine kinase inhibitor therapyLocally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer（NSCLC）Adult patients.

This approval marks the second lung cancer indication for Amivantamab in China this year. Previously, Rybocent® was approved in February this year for the treatment ofFirst-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations。

This approval is based on the robust efficacy and safety data from the MARIPOSA-2 Phase III study. The study results demonstrate:

• Compared with the single chemotherapy group,Amivantamab Combined with Chemotherapy Reduces the Risk of Disease Progression or Death by 52%`, Median Progression-Free Survival`（PFS）was 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, the investigator-assessed median PFS was 10.3 months, compared to 4.2 months in the chemotherapy-alone group.（HR=0.39；95%CI：0.26–0.59；P<0.0001）。

Notably, based on the results of the MARIPOSA-2 clinical trial, the NCCN Clinical Practice Guidelines issued by the National Comprehensive Cancer Network recommend amivantamab in combination with chemotherapy as the sole Category 1 preferred treatment option for patients with advanced NSCLC harboring classic EGFR mutations following disease progression 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 each year in China, accounting for more than one-third of the total number of lung cancer patients worldwide. EGFR gene mutations are the most common driver gene in non-small cell lung cancer, with approximately 40% of patients in China carrying this mutation type.

EGFR has various sensitive mutation types, among which exon 19 deletion and exon 21 L858R point mutation are the most common mutation types of EGFR. According to statistics, the 5-year survival rate of patients with EGFR-mutated advanced non-small cell lung cancer who receive EGFR tyrosine kinase inhibitor (TKI) treatment is less than 20%.

The acquired resistance mechanisms that emerge after prior EGFR TKI monotherapy are diverse and polyclonal, making targeted therapy more challenging post disease progression and thus limiting its efficacy. Additionally, combining immunotherapy with chemotherapy has not demonstrated clinically meaningful improvements.

Therefore, the emergence of amivantamab combined with chemotherapy provides an important new treatment option for patients with EGFR-mutated non-small cell lung cancer whose disease has progressed after EGFR TKI therapy.

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