Rybrevant

Amivantamab-vmjw (Rybrevant), a bispecific epidermal growth factor receptor (EGFR) and MET receptordirected antibody, was approved by the U.S. Food and Drug Administration (FDA) in May 2021 for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, in patients whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval of amivantamab for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and efficacy of amivantamab was evaluated in a phase 1, open-label study of patients with metastatic or unresectable NSCLC and EGFR exon 20 mutations whose disease had progressed on or after platinum based chemotherapy (CHRYSALIS, NCT02609776). Included patients (median age, 62 years) received amivantamab 1050 mg (baseline body weight less than 80 kg) or 1400 mg (baseline body weight 80 kg or greater) once weekly for 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. Amivantamab produced an overall response rate (ORR) of 40% (complete response, 3.7%) in cohort patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations who had progressed on or after platinum-based chemotherapy (n=81) from the CHRYSALIS trial. The median duration of response (DOR) was 11.1 months, with 63% of patients having a DOR of 6 months or longer. Patients had adenocarcinoma (95%), had received prior immunotherapy (46%), had previously treated brain metastases (22%), and received a median of 2 prior therapies (range, 1 to 7). National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 7.2021) contain recommendations for the use of amivantamab in NSCLC. <a id="