Johnson & Johnson Unveils First NSCLC Drug at CIIE, Officially Enters Lung Cancer Market

China Finance and Economics News, November 7th: At the 7th CIIE, Johnson & Johnson showcased its groundbreaking lung cancer drug once again, bringing the world's first bispecific antibody RYBREVANT (Amivantamab Injection) for EGFR/MET gene mutations in non-small cell lung cancer (NSCLC), marking its official entry into the lung cancer field.

In October 2023, the first marketing application for Amivantamab was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Prior to this, the therapy had been designated as a breakthrough treatment by the CDE for treating specific types of NSCLC.

As the world's first approved EGFR/c-MET bispecific antibody, Johnson & Johnson's Amivantamab has achieved significant breakthroughs in research and development. Studies show that its combination with Lazertinib demonstrates superior clinical outcomes. The marketing application for the combination therapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR-sensitive mutations was accepted by the CDE on January 26, 2024. In September 2024, the marketing application for Amivantamab Injection (subcutaneous injection) was also accepted. This marks the first submission for marketing approval of the subcutaneous formulation of Amivantamab in China, which is expected to transform the treatment landscape for such patients, offering more convenient and effective treatment options for clinicians and patients.

As a fully human EGFR-MET bispecific antibody, amivantamab has multiple mechanisms of action. It not only blocks EGFR and MET-mediated signaling pathways, but its specially engineered Fc region can also direct immune cells to target tumor cells, thereby further inhibiting the proliferation and spread of tumor cells through immune effects such as antibody-dependent cell-mediated cytotoxicity (ADCC). Clinical studies have shown that amivantamab significantly prolongs progression-free survival (PFS) in patients. Particularly for patients with brain metastases, the combination of amivantamab and chemotherapy has demonstrated effective control, helping to slow disease progression.

Lung cancer is one of the tumors with the highest incidence and mortality rates globally. Among Chinese non-small cell lung cancer (NSCLC) patients, those carrying EGFR mutations account for approximately 50%, making it the most common driver gene and a focal point of research in the NSCLC field. The upcoming availability of Amivantamab in China will represent an important exploration in the field of precision medicine, offering more options for NSCLC patients with EGFR mutations and their clinicians.