Johnson & Johnson (JNJ.US) Evanti monoclonal antibody combination therapy approved and launched in China for first-line treatment of lung cancer.

On February 11, Johnson & Johnson (JNJ.US) announced that amivantamab injection has been approved by the National Medical Products Administration (NMPA) of China. Amivantamab is a EGFR/MET bispecific antibody therapy, approved for use in combination with carboplatin and pemetrexed, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients confirmed to carry the EGFR exon 20 insertion mutation. Amivantamab (marketed as Rybrevant in English) is a fully humanized bispecific antibody targeting EGFR and MET developed by a subsidiary of Johnson & Johnson. In addition to blocking EGFR and MET-mediated signaling, it can also guide immune cells to target tumors carrying activating and resistant EGFR/MET mutations and amplifications. In China, amivantamab was included as a breakthrough therapy in 2020 by the Center for Drug Evaluation (CDE) for the treatment of metastatic or unresectable NSCLC patients with EGFR exon 20 insertion mutations who have progressed during or after platinum-based doublet chemotherapy, or who are intolerant to platinum-based chemotherapy. According to a news release from Johnson & Johnson, the approval of amivantamab was based on results from a randomized, open-label, phase 3 PAPILLON clinical trial. The study showed that amivantamab in combination with chemotherapy reduced the risk of disease progression or death by 61% compared to chemotherapy alone.