The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III confirmatory study for the bispecific antibody Rybrevant (amivantamab). The study focused on patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. According to the press release, the trial successfully met its primary endpoint of significantly improving progression-free survival (PFS), with a safety profile consistent with the individual medicines used.
Reinforcing Accelerated Approval and Ongoing Trials
These encouraging results further support the accelerated approval granted to Rybrevant in the US in 2021. The biologic is currently the subject of several combination trials with other molecules for the treatment of NSCLC, indicating the potential for expanded use and improved outcomes in lung cancer treatment.-Fineline Info & Tech