![]() “Despite treatment advances, there remains a high unmet need for patients with EGFR-mutated lung cancer, and these study insights reinforce the potential of amivantamab to treat this underserved patient population," said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. 3 In contrast, patients with low MET expression had a response rate of 14 percent with a median PFS of 4.2 months. 3, 9 Among patients with MET overexpression as identified by immunohistochemistry, the response rate was 61 percent with a median PFS of 12.2 months. 8 Consistent with a prior presentation at ASCO 2021, these data indicate that immunohistochemical (IHC) staining (a testing method that using antibodies to determine the relative level of certain antigens or markers in cancer tissue samples) for MET may identify patients more likely to benefit from treatment with the combination of amivantamab and lazertinib. 3 CHRYSALIS-2 ( NCT04077463) is an open-label study to evaluate the safety and pharmacokinetics of lazertinib as monotherapy or in combination with amivantamab. 7 Data from Cohort D of the Phase 1/1b CHRYSALIS-2 study, which enrolled such patients, were highlighted in an oral presentation at ASCO this year. 6 There are no approved targeted therapies, and the standard of care is platinum-doublet chemotherapy. ![]() Patients with advanced NSCLC harbouring common EGFR mutations including ex19del or L858R who have experienced disease progression on or after osimertinib are a population with substantial unmet medical need. New Analyses on Predictive Biomarkers for Response to Amivantamab and Lazertinib Combination Therapy 1 The longest ongoing duration of treatment is over three years (37.2 months), and longest DOR is nearly three years (35.7 months). 1 The estimated PFS rate was 85 percent after one year, 65 percent at two years and 51 percent at three years. 1, 4 After a median follow-up of nearly three years (33.6 months), the median duration of response (DOR), median progression-free survival (PFS) and overall survival (OS) were not yet reached. Patients enrolled in the treatment-naïve cohort from the ongoing CHRYSALIS ( NCT02609776) study had NSCLC characterised by common EGFR mutations either an EGFR exon 19 deletion (ex19del) (n=11) or L858R mutation (n=9). 1 These findings and additional data, including an analysis of predictive biomarkers from Cohort D of the Phase 1/1b CHRYSALIS-2 study evaluating a chemotherapy-free regimen of amivantamab in combination with lazertinib (Abstract #9013) 3 and updated safety results from the Phase 1 PALOMA study evaluating the subcutaneous (SC) administration of amivantamab as a monotherapy (Abstract #9126) 2, were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, from 2-6 June. Updated safety analysis from the Phase 1 PALOMA study evaluating the subcutaneous delivery of amivantamab showed shorter administration time and a marked reduction in the incidence and severity of infusion-related reactions compared with intravenous administration 2īEERSE, BELGIUM, J(GLOBE NEWSWIRE) - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced long-term results from the CHRYSALIS study, which showed the combination of RYBREVANT ® ▼ (amivantamab) and lazertinib*, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was associated with sustained antitumour activity as a first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC) (Abstract #9134). Further analyses from the Phase 1/1b CHRYSALIS-2 study showed patients with osimertinib pre-treated EGFR-mutated lung cancer who have a MET positive biomarker had an overall response rate of 61 percent and a median progression free survival of 12.2 months when treated with the chemotherapy-free combination of amivantamab and lazertinib 1
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