Amivantamab in egfr exon 20 insertion- mutated non-small-cell lung cancer progressing on platinum chemotherapy: Initial results from the chrysalis phase i study
Journal
Journal of Clinical Oncology
Journal Volume
39
Journal Issue
30
Pages
3391-3402
Date Issued
2021
Author(s)
Park K.
Haura E.B.
Leighl N.B.
Mitchell P.
Shu C.A.
Girard N.
Viteri S.
Han J.-Y.
Kim S.-W.
Lee C.K.
Sabari J.K.
Spira A.I.
Yang T.-Y.
Kim D.-W.
Lee K.H.
Sanborn R.E.
Trigo J.
Goto K.
Lee J.-S.
Govindan R.
Bauml J.M.
Garrido P.
Krebs M.G.
Reckamp K.L.
Xie J.
Curtin J.C.
Haddish-Berhane N.
Roshak A.
Millington D.
Lorenzini P.
Thayu M.
Knoblauch R.E.
Cho B.C.
Abstract
PURPOSE: ) exon 20 insertion (Exon20ins) mutations exhibits inherent resistance to approved tyrosine kinase inhibitors. Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, binds to each receptor's extracellular domain, bypassing resistance at the tyrosine kinase inhibitor binding site. METHODS: Exon20ins NSCLC population treated at the recommended phase II dose of 1,050 mg amivantamab (1,400 mg, ≥ 80 kg) given once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. RESULTS: In the efficacy population (n = 81), the median age was 62 years (range, 42-84 years); 40 patients (49%) were Asian, and the median number of previous lines of therapy was two (range, 1-7). The overall response rate was 40% (95% CI, 29 to 51), including three complete responses, with a median duration of response of 11.1 months (95% CI, 6.9 to not reached). The median progression-free survival was 8.3 months (95% CI, 6.5 to 10.9). In the safety population (n = 114), the most common adverse events were rash in 98 patients (86%), infusion-related reactions in 75 (66%), and paronychia in 51 (45%). The most common grade 3-4 adverse events were hypokalemia in six patients (5%) and rash, pulmonary embolism, diarrhea, and neutropenia in four (4%) each. Treatment-related dose reductions and discontinuations were reported in 13% and 4% of patients, respectively. CONCLUSION: Exon20ins mutations after progression on platinum-based chemotherapy.
SDGs
Publisher
American Society of Clinical Oncology
Type
journal article