Johnson & Johnson's Amivantamab Approved in China as First-Line Therapy for EGFR Exon 20 Insertion-Mutant NSCLC, Marking a Milestone in Lung Cancer Treatment

Johnson & Johnson officially enters the lung cancer treatment field in China. On February 11, Johnson & Johnson announced that its innovative therapeutic drug, Amivantamab Injection, has been officially approved by the National Medical Products Administration to be administered in combination with carboplatin and pemetrexed forFirst-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations.As previously predicted:

▍Amivantamab

The approval of Amivantamab this time is based on the results of a randomized, open-label, PAPILLON Phase III clinical study. The study shows that,Compared with chemotherapy alone, the combination of Amivantamab and chemotherapy reduced the risk of disease progression or death by 61%.Based on the results of the PAPILLON clinical trial, the National Comprehensive Cancer Network (NCCN) "NCCN Clinical Practice Guidelines" recommend amivantamab in combination with chemotherapy as the preferred first-line treatment regimen for patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

▍EGFR 20 Mutation

EGFR gene mutations are the most common driver genes in non-small cell lung cancer, with about 40% of patients in China carrying this type of mutation. Currently, 25%-40% of EGFR-mutated patients are unable to receive second-line treatment due to severe disease progression. EGFR exon 20 insertion mutations are the third most common type of mutation. Typically, non-small cell lung cancer driven by this mutation has a poorer prognosis and shorter survival compared to lung cancer patients with common EGFR mutations. Research shows,NSCLC patients carrying EGFR exon 20 insertion mutations have limited efficacy with currently approved third-generation EGFR-TKI targeted drugs and chemotherapy, generally face a poor prognosis, and encounter dual challenges in survival time and quality of life.

Besides Amivantamab,Currently, there are 11 bispecific antibody drugs targeting EGFR/cMET globally still in active development, with the most advanced being HS-20117 from Primus, which has already entered Phase III clinical trials.

In addition to HS-20117, there are 7 China-produced new drugs under development:

• There are 2 products in clinical Phase I/II, respectively.Hengrui's SHR-9839 and EpimAb's EMB-01;

• One has been approved for clinical use,It is the subcutaneous formulation of SHR-9839 developed by Hengrui.

• Four of them are still in the preclinical stage, respectively belonging toKangyuan Bochuang, Dongcheng Pharmaceutical, Fuhong Hanlin, and Junshi.

Screenshot source: Insight database (Statistics as of: February 6, 2025)

Source: Southern Media Group, Insight Database