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Amivantamb Under Study in Treatment of EGFR Exon 20 Insertion–Mutated NSCLC

By: Gavin Calabretta, BS
Posted: Friday, September 3, 2021

New findings from a phase I, open-label, dose-escalation, and dose-expansion trial suggest that amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, may prove to be a safe and effective treatment for patients with non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations after disease progression on platinum-based chemotherapy. Based on preliminary efficacy data, the drug received Breakthrough Therapy designation by the U.S. Food and Drug Administration, and expanded data from the trial were recently published in the Journal of Clinical Oncology. According to its contributors, the main objective of the CHRYSALIS trial was to determine the recommended phase II dose of the novel treatment.

“The results from the study are encouraging, as we’re seeing durable responses among patients with a hard-to-treat subtype of non–small cell lung cancer,” said study author Eric B. Haura, MD, of Moffit Cancer Center, Florida, in an institutional press release. “In addition, we have seen responses in patients who have had prior therapy directed against these rare EGFR mutations.”  

Between 2016 and 2020, 362 patients with unresectable or metastatic disease and qualifying EGFR or MET mutations were enrolled in the study. Treatment continued until disease progression, toxicity became unacceptable, or consent was withdrawn. In efficacy testing (n = 81), 3 confirmed complete responses and 29 partial responses were observed, for an objective response rate of 40%. Additionally, the median duration of response of 11.1 months and a median progression-free survival of 8.3 months were recorded. In contrast, objective response rate and median progression-free survival across second-line treatments were 13% and 3.5 months.

Furthermore, the safety profile of the drug was determined to be tolerable and consistent with on-target anti-EGFR and anti-MET action. However, certain adverse effects occurred—among the most common were rash (86%), paronychia (45%), and stomatitis (21%).

Disclosure: For full disclosures of the study authors, visit ascopubs.org.



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