Name:
A plain language summary of results from the CHRYSALIS study
Description:
A plain language summary of results from the CHRYSALIS study
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Upload Date:
2024-01-05T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
ALEX SPIRA: I'm Dr. Alex Spira of Virginia Cancer Specialists. On behalf of my co-authors, it's my pleasure to describe the results of the 114 patients with exon 20 insertion mutations who received amivantamab in the ongoing CHRYSALIS study. This study evaluated amivantamab in multiple groups of patients with various types of non-small cell lung cancer. This summary may be helpful for patients, their families, and health care professionals caring for a patient who has non-small cell lung cancer with a specific type of genetic mutation called an exon 20 insertion mutation in the epidermal growth factor receptor gene, also known as EGFR.
ALEX SPIRA: Non-small cell lung cancer or NSCLC is the most common type of lung cancer, affecting up to 85% of patients with lung cancer in the United States. Mutations in the EGFR gene are some of the most common causes of non-small cell lung cancer. Mutations in other genes, including MET are also found in non-small cell lung cancer. It is important to test for specific mutations before treatment starts to ensure appropriate diagnosis and treatment.
ALEX SPIRA: Targeted therapies are medicines that find tumor cells with specific mutations and kill them, aiming to preserve normal, healthy cells. Patients in the CHRYSALIS study with EGFR exon 20 insertion mutations had advanced disease. Cancer had already progressed after chemotherapy. Amivantamab is a targeted therapy which was first approved by the FDA in 2021 as a treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations after disease progression on chemotherapy, based on the results of CHRYSALIS.
ALEX SPIRA: This summary focuses on the patients in the CHRYSALIS study with EGFR exon 20 insertion mutations. Amivantamab is a fully human bispecific antibody, meaning that it binds to both EGFR and MET receptors. This reduces the activity of EGFR and MET receptors, stimulating the immune system and leads to cancer cell death. EGFR and MET are found on both normal, healthy cells and cancer cells. Thus, some side effects are expected from amivantamab, binding these receptors.
ALEX SPIRA: Prior to receiving amivantamab, patients received other medications, such as steroids, antihistamines, antipyretics, before and during the infusion to manage potential infusion-related reactions. Patients were educated about IRRs with an emphasis on how to recognize symptoms and to report them as soon as possible during or after the infusion. Patients with EGFR exon 20 insertion mutations received amivantamab over time through a vein, known as an intravenous infusion at different doses depending on body weight.
ALEX SPIRA: The first dose of amivantamab was split and administered over two days to help minimize the risk of infusion-related reactions that can occur with the infusion of antibody based 0 The safety of amivantamab was assessed in 114 patients with EGFR exon 20 insertion mutations, also called the safety group. Of these 114 patients, the effectiveness of amivantamab on the cancer was examined in 81 patients, also called the efficacy group. .
ALEX SPIRA: These 81 patients were evaluated for amivantamab efficacy because they completed at least three follow up visits with the doctor by June 8 2020. Data from the remaining 33 patients was not included in the analysis of the efficacy group. CHRYSALIS was a multinational study where 59% were female, median age at enrollment was 62, and 53% had no history of tobacco use. Patients survived without advancing disease for a median of 8.3 months.
ALEX SPIRA: Tumors were not detectable in 4% of patients or decreased in size in 36% of patients for an overall response rate of 40%. Notably, disease was controlled in another 48% of patients, meaning they had no measurable change in tumor size. With any therapies targeting tumor growth, there is the potential for side effects. So it is important that patients and caregivers are educated about these in advance.
ALEX SPIRA: The most common side effects were IRRs, rash, and nail bed infections. Common IRR symptoms include fever, rash, and nausea. Most side effects were mild, tolerable, and manageable. In some patients, the amivantamab dose was reduced to manage these side effects. In some cases, treatment was temporarily or permanently stopped. Summary of results.
ALEX SPIRA: In the CHRYSALIS study, amivantamab reduced tumor size and delayed tumor growth and spread in 40% of patients and control disease in 48% of patients. Side effects with amivantamab were predictable, typically mild and tolerable and could be managed with education, pre medications, and dose modifications where necessary. Amivantamab was approved by the FDA for patients with non-small cell lung cancer exon 20 insertion mutations whose disease had progressed after chemotherapy.
ALEX SPIRA: Testing for EGFR and other mutations in non-small cell lung cancer is a critical first step to getting an appropriate therapy.