RT Journal Article
T1 Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study
A1 Park, Keunchil
A1 Haura, Eric B.
A1 Leighl, Natasha B.
A1 Mitchell, Paul
A1 Shu, Catherine A.
A1 Girard, Nicolas
A1 Viteri, Santiago
A1 Han, Ji-Youn
A1 Kim, Sang-We
A1 Lee, Chee Khoon
A1 Sabari, Joshua K.
A1 Spira, Alexander, I
A1 Yang, Tsung-Ying
A1 Kim, Dong-Wan
A1 Lee, Ki Hyeong
A1 Sanborn, Rachel E.
A1 Trigo, Jose
A1 Goto, Koichi
A1 Lee, Jong-Seok
A1 Yang, James Chih-Hsin
A1 Govindan, Ramaswamy
A1 Bauml, Joshua M.
A1 Garrido, Pilar
A1 Krebs, Matthew G.
A1 Reckamp, Karen L.
A1 Xie, John
A1 Curtin, Joshua C.
A1 Haddish-Berhane, Nahor
A1 Roshak, Amy
A1 Millington, Dawn
A1 Lorenzini, Patricia
A1 Thayu, Meena
A1 Knoblauch, Roland E.
A1 Cho, Byoung Chul
K1 Growth-factor receptor
K1 Bispecific antibody
K1 Gene-mutations
K1 Trial
K1 Jnj-61186372
K1 Gefitinib
K1 Outcomes
K1 Nsclc
K1 Cmet
AB PURPOSE Non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 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 CHRYSALIS is a phase I, open-label, dose-escalation, and dose-expansion study, which included a population with EGFR Exon20ins NSCLC. The primary end points were dose-limiting toxicity and overall response rate. We report findings from the postplatinum EGFR 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 Arnivantamab, via its novel mechanism of action, yielded robust and durable responses with tolerable safety in patients with EGFR Exon20ins mutations after progression on platinum-based chemotherapy. (C) 2021 by American Society of Clinical Oncology
PB Lippincott williams & wilkins
SN 0732-183X
YR 2021
FD 2021-10-20
LK https://hdl.handle.net/10668/27015
UL https://hdl.handle.net/10668/27015
LA en
DS RISalud
RD Apr 18, 2025