Research & Development

Janssen, part of Johnson & Johnson, has announced new long-term data from its CHRYSALIS study, which assessed Rybrevant (amivantamab) in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease continued to progress while receiving platinum-based chemotherapy.

The data from this study demonstrated long-term response and safety profiles for this group, with the data being presented at the 2023 European Lung Cancer Congress (ELCC).

Study investigators assessed the safety and efficacy of the drug in this group of patients, who were treated with the recommended phase 2 dose of 1050mg (or 1400mg for patients weighing over 80kg). The primary endpoint was overall response rate (ORR) as per Response Evaluation Criteria in Solid Tumours Version 1.1. Further endpoints included duration of response (DOR), clinical benefit rate, progression free survival (PFS) and overall survival (OS).

After 19.2 months the median OS with Rybrevant was 23 months, with a two-year OS rate of 47%. The ORR was 37%, with a median DOR of 12.5 months, and a median PFS of 6.9 months.

Pilar Garrido, MD, associate professor of medical oncology at Universidad de Alcalá, head of Medical Oncology Department at the University Hospital Ramón y Cajal in Madrid, Spain, and principal investigator, commented: “With this new data, amivantamab showed long-term consistent efficacy regardless of prior therapies or response to prior platinum chemotherapy. Due to the aggressive nature of NSCLC with EGFR exon 20 insertion mutations, treatment with targeted therapies is an important consideration when identifying a treatment option for patients.”

Martin Vogel, EMEA therapeutic area lead oncology at Janssen-Cilag GmbH, added: “Despite treatment advances, patients with advanced NSCLC with EGFR exon 20 insertion mutations continue to face poor clinical outcomes. These insights reinforce the potential of amivantamab as a targeted and effective option for these patients, and our commitment to lead the way in precision medicine approaches, whereby we are better able to identify the distinct patient populations most likely to benefit from specific treatments.”

Kiran Patel, MD, vice president, Clinical Development, Solid Tumours, Janssen Research & Development, LLC, said: “The long-term CHRYSALIS data presented at ELCC support amivantamab as an important treatment option for patients with EGFR exon 20 insertion mutation-positive NSCLC, providing valuable clinical insights that may help inform treatment decisions. We’re committed to transforming the treatment of lung cancer through continued research and the development of targeted therapies for genetic-mutated disease where high unmet needs continue to exist.”