Plain language summary of subcutaneous vs IV amivantamab plus lazertinib in EGFR -altered non-small-cell lung cancer

Plain Language SummaryWhat is this summary about?This plain language summary describes results from the phase 3 PALOMA-3 study in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) and common genetic alterations in the epidermal growth factor receptor (EGFR) gene, whose disease progressed (worsened) after receiving the EGFR tyrosine kinase inhibitor (TKI) osimertinib and chemotherapy.Researchers evaluated how safe and how well the bispecific antibody amivantamab (RYBREVANT®) worked when given by subcutaneous injection or intravenous (IV) infusion, along with the EGFR-TKI lazertinib (LAZCLUZE®). This summary also describes how subcutaneous or IV amivantamab impacted treatment experience and medical resource use.Amivantamab plus lazertinib was approved in many regions worldwide and recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the first treatment after diagnosis in adult patients with locally advanced or metastatic NSCLC with common EGFR alterations. Amivantamab was first approved to be given via IV infusion but was recently approved for subcutaneous administration based on data from this study in patients who received amivantamab plus lazertinib after their cancer worsened on or after receiving osimertinib and chemotherapy.What were the results?418 patients were randomly assigned to receive either subcutaneous amivantamab plus lazertinib or IV amivantamab plus lazertinib. The way subcutaneous amivantamab was processed by patients’ bodies was consistent with IV amivantamab based on pharmacokinetics. Both treatment groups were consistent in terms of the amount of time without their cancer growing and tumor shrinking. Patients who received subcutaneous amivantamab spent less time receiving treatment, had reduced use of medical resources, and found subcutaneous administration more convenient compared with those who received IV amivantamab.Side effects are common with all cancer treatments. Patients who are treated with IV amivantamab often report infusion-related reactions (IRRs). Fewer patients who received subcutaneous amivantamab experienced IRRs (13% vs 66%) compared with those who received IV amivantamab. Fewer events of venous thromboembolism were observed with subcutaneous versus IV amivantamab (9% vs 14%).What were the main conclusions reported by the researchers?Subcutaneous amivantamab showed effectiveness consistent with that of IV amivantamab. However, patients who received subcutaneous amivantamab had fewer infusion-related and venous thromboembolism side effects and found subcutaneous administration more convenient than patients who received IV amivantamab.Clinical trial number: NCT05388669