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Positive early clinical results for amivantamab plus lazertinib in NSCLC

*September 2021*

Encouraging preliminary findings from two ongoing studies of combination therapy with amivantamab plus the third-generation EGFR tyrosine kinase inhibitor (TKI) lazertinib were presented today at the ESMO Congress 2021, offering novel promise to a patient population that has a high unmet need for new treatments, particularly in later-line settings.

Amivantamab is a bispecific antibody that targets EGFR and c-mesenchymal epithelial transition factor (MET) receptors. The open-label phase I CHRYSALIS study is evaluating amivantamab both as monotherapy and in combination with lazertinib in 166 patients with EGFR-mutated NSCLC who have progressed on the EGFR TKI osimertinib (Abstract 1192MO). After a median follow up of 6.9 months, the objective response rate (ORR) in the monotherapy arm was 19% (95% confidence interval [CI], 12–27) and the clinical benefit rate (CBR) was 48% (95% CI, 39–57). Higher ORR and CBR rates were reported in the combination arm after a median follow-up of 11.1 months (36% [95% CI, 22–51] and 64% [95% CI, 49–78], respectively). Median duration of response in the monotherapy arm was 5.9 months and 9.6 months in the combination arm. Patients in the monotherapy arm were pre-selected for resistance mutations (including C797S) or MET amplification, whereas those in the combination arm were unselected and chemo-naïve.

A second ongoing, phase I trial (CHRYSALIS-2) is examining amivantamab plus lazertinib in 136 patients with an EGFR Exon19 deletion or a L858R point mutation and disease progression after osimertinib and platinum chemotherapy (third-/fourth- or at least fifth line). Preliminary results show an ORR of 41% (95% CI, 24–61) among 29 patients evaluable for response at a median follow-up of 4.6 months, and 21% (95% CI, 11–36] in 47 heavily pre-treated patients (Abstract 1193MO).