A plain language summary of the results from the group of patients in the CHRYSALIS study with EGFR exon 20 insertion-mutated non-small-cell lung cancer who received amivantamab.

WHAT IS THIS SUMMARY ABOUT?: This is a plain language summary of an article published in the Journal of Clinical Oncology in 2021. It describes the first results from 1 group of patients in the phase 1 CHRYSALIS study with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. This part of the CHRYSALIS study (called cohort D) investigated the bispecific antibody amivantamab (brand name RYBREVANT®) in patients with non-small-cell lung cancer (NSCLC) with an EGFR ex20ins mutation. EGFR mutations are one of the most common causes of NSCLC tumors, with EGFR ex20ins mutations being more common among people of Asian descent. Patients who took part in this study had cancer that could not be removed by surgery, and whose cancer had worsened after receiving other forms of treatment, such as chemotherapy. Typically, patients with this type of mutation are difficult to treat or do not experience treatment response with commonly used therapies that target EGFR. WHAT WERE THE RESULTS?: The CHRYSALIS study took place between May 27, 2016, and June 8, 2020, in select hospitals in the USA, Japan and South Korea. In cohort D, amivantamab showed promising results, with an overall response rate of 40%. This means that 4 of every 10 patients in CHRYSALIS cohort D had tumors that shrank or were no longer measurable. Clinical Trial Registration: NCT02609776 (the CHRYSALIS Phase I Study) (ClinicalTrials.gov).

A plain language summary of the results from the group of patients in the CHRYSALIS study with EGFR exon 20 insertion-mutated non-small-cell lung cancer who received amivantamab.

What is this summary about? This is a plain language summary of an article published in the Journal of Clinical Oncology in 2021. It describes the first results from 1 group of patients in the phase 1 CHRYSALIS study with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. This part of the CHRYSALIS study (called cohort D) investigated the bispecific antibody amivantamab (brand name RYBREVANT^®) in patients with non-small-cell lung cancer (NSCLC) with an EGFR ex20ins mutation. EGFR mutations are one of the most common causes of NSCLC tumors, with EGFR ex20ins mutations being more common among people of Asian descent. Patients who took part in this study had cancer that could not be removed by surgery, and whose cancer had worsened after receiving other forms of treatment, such as chemotherapy. Typically, patients with this type of mutation are difficult to treat or do not experience treatment response with commonly used therapies that target EGFR.What were the results? The CHRYSALIS study took place between May 27, 2016, and June 8, 2020, in select hospitals in the USA, Japan and South Korea. In cohort D, amivantamab showed promising results, with an overall response rate of 40%. This means that 4 of every 10 patients in CHRYSALIS cohort D had tumors that shrank or were no longer measurable. Clinical Trial Registration: NCT02609776 (the CHRYSALIS Phase I Study) (ClinicalTrials.gov)[Box: see text]Link to original article here.

Infusion-Related Reaction Management With Amivantamab for EGFR Exon 20 Insertion Mutation NSCLC: A Practical Guide for Advanced Practitioners.

Many targeted therapies to treat genetic mutations in non-small cell lung cancer (NSCLC) have been developed. Amivantamab (Rybrevant), a bispecific antibody targeting the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor, was approved by the US Food and Drug Administration in 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC EGFR exon 20 insertions, whose disease progressed on or after platinum-based chemotherapy. Amivantamab is administered intravenously weekly for 4 weeks, then every 2 weeks starting at Week 5, as 1,050 mg (body weight [BW] < 80 kg) or 1,400 mg (BW ≥ 80 kg), with the first dose split over 2 days. Infusion-related reactions (IRRs) are common with amivantamab and may present as chills, dyspnea, nausea, chest discomfort, and vomiting. To aid in the prevention, diagnosis, and treatment of IRRs, we evaluated infusion duration, IRR timing, and IRR severity in this post hoc analysis of patients who received amivantamab in CHRYSALIS. Infusion duration decreased over time, with a median infusion time at Cycle 1 Day 1 (C1D1) of 4.70 hours (1,050 mg) and 5.08 hours (1,400 mg), decreasing to 2.20 and 2.25 hours, respectively, by C1D22. Of the 273 IRRs, 98% occurred on C1D1 or C1D2, with median onset and time to resolution of 60 minutes. Most IRRs occurred during the infusion, were low grade, and were manageable with intervention strategies or treatment modifications. Advanced practitioners are critical in preventing, diagnosing, and managing IRRs, including educating patients and families, accurately administering infusions, prescribing premedications, and closely monitoring for IRRs.