Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trialopen access
- Authors
- Cho, Byoung Chul; Kim, Dong-Wan; Spira, Alexander I.; Gomez, Jorge E.; Haura, Eric B.; Kim, Sang-We; Sanborn, Rachel E.; Cho, Eun Kyung; Lee, Ki Hyeong; Minchom, Anna; Lee, Jong-Seok; Han, Ji-Youn; Nagasaka, Misako; Sabari, Joshua K.; Ou, Sai-Hong Ignatius; Lorenzini, Patricia; Bauml, Joshua M.; Curtin, Joshua C.; Roshak, Amy; Gao, Grace; Xie, John; Thayu, Meena; Knoblauch, Roland E.; Park, Keunchil
- Issue Date
- Oct-2023
- Publisher
- NATURE PORTFOLIO
- Citation
- NATURE MEDICINE, v.294, no.10, pp 2577 - 2585
- Pages
- 9
- Journal Title
- NATURE MEDICINE
- Volume
- 294
- Number
- 10
- Start Page
- 2577
- End Page
- 2585
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/90071
- DOI
- 10.1038/s41591-023-02554-7
- ISSN
- 1078-8956
1546-170X
- Abstract
- Patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) often develop resistance to current standard third-generation EGFR tyrosine kinase inhibitors (TKIs); no targeted treatments are approved in the osimertinib-relapsed setting. In this open-label, dose-escalation and dose-expansion phase 1 trial, the potential for improved anti-tumor activity by combining amivantamab, an EGFR-MET bispecific antibody, with lazertinib, a third-generation EGFR TKI, was evaluated in patients with EGFR-mutant NSCLC whose disease progressed on third-generation TKI monotherapy but were chemotherapy naive (CHRYSALIS cohort E). In the dose-escalation phase, the recommended phase 2 combination dose was established; in the dose-expansion phase, the primary endpoints were safety and overall response rate, and key secondary endpoints included progression-free survival and overall survival. The safety profile of amivantamab and lazertinib was generally consistent with previous experience of each agent alone, with 4% experiencing grade >= 3 events; no new safety signals were identified. In an exploratory cohort of 45 patients who were enrolled without biomarker selection, the primary endpoint of investigator-assessed overall response rate was 36% (95% confidence interval, 22-51). The median duration of response was 9.6 months, and the median progression-free survival was 4.9 months. Next-generation sequencing and immunohistochemistry analyses identified high EGFR and/or MET expression as potential predictive biomarkers of response, which will need to be validated with prospective assessment.
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