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Amivantamab Plus Lazertinib in Patients With EGFR-mutant Non-small Cell Lung Cancer (NSCLC) After Progression on Osimertinib and Platinum-based Chemotherapy: Results From CHRYSALIS-2 Cohort A.

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Amivantamab Plus Lazertinib in Patients With EGFR-mutant Non-small Cell Lung Cancer (NSCLC) After Progression on Osimertinib and Platinum-based Chemotherapy: Results From CHRYSALIS-2 Cohort A. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer Besse, B., Goto, K., Wang, Y., Lee, S. H., Marmarelis, M. E., Ohe, Y., Caro, R. B., Kim, D. W., Lee, J. S., Cousin, S., Ichihara, E., Li, Y., Paz-Ares, L., Ono, A., Sanborn, R. E., Watanabe, N., Jose de Miguel, M., Helissey, C., Shu, C. A., Spira, A. I., Tomasini, P., Chih-Hsin Yang, J., Zhang, Y., Felip, E., Griesinger, F., Waqar, S. N., Calles, A., Neal, J. W., Baik, C. S., Jänne, P. A., Shreeve, S. M., Curtin, J. C., Patel, B., Gormley, M., Lyu, X., Chen, J., Chu, P. L., Mahoney, J., Trani, L., Bauml, J. M., Thayu, M., Knoblauch, R. E., Cho, B. C. 2025

Abstract

Treatment options for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with disease progression on/after osimertinib and platinum-based chemotherapy are limited.CHRYSALIS-2 Cohort A evaluated amivantamab+lazertinib in patients with EGFR exon 19 deletion- or L858R-mutated NSCLC with disease progression on/after osimertinib and platinum-based chemotherapy. Primary endpoint was investigator-assessed objective response rate (ORR). Patients received intravenous amivantamab 1050 mg (1400 mg if =80 kg) plus oral lazertinib 240 mg.In Cohort A (n=162), investigator-assessed ORR was 28% (95% CI, 22-36). Blinded independent central review (BICR)-assessed ORR was 35% (95% CI, 27-42), with median duration of response (DoR) of 8.3 months (95% CI, 6.7-10.9) and clinical benefit rate of 58% (95% CI, 50-66). At a median follow-up of 12 months, 32/56 responders (57%) achieved a DoR =6 months. Median progression-free survival by BICR was 4.5 months (95% CI, 4.1-5.8); median overall survival was 14.8 months (95% CI, 12.2-18.0). Preliminary evidence of central nervous system-anti-tumor activity was reported among 7 patients with baseline brain lesions and no prior brain radiation/surgery. Exploratory biomarker analyses using circulating tumor DNA next-generation sequencing showed responses in patients with and without identified EGFR/MET-dependent resistance. Most frequent adverse events were rash (grouped term; 81%), infusion-related reaction (68%), and paronychia (52%). Most common grade =3 treatment-related adverse events were rash (grouped term; 10%), infusion-related reaction (9%), and hypoalbuminemia (6%).For patients with limited treatment options, amivantamab+lazertinib demonstrated anti-tumor activity with a safety profile characterized by EGFR/MET-realated adverse events, which were generally manageable.

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