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Janssen’s Rybrevant yields positive data

Results from the trial showed a long-term response among specific lung cancer populations.

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new long-term data from its CHRYSALIS study.

The research has been evaluating Rybrevant – also known as amivantamab – involving patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy.

Results from the trial demonstrated a long-term response and safety profile among this population and have been presented at the 2023 European Lung Cancer Congress in Denmark.

During the CHRYSALIS study, patients were treated at the recommended phase 2 dose of 1050mg to 1400mg for a patient weight of at least 80kg. The primary endpoint was the overall response rate (ORR) per response evaluation criteria in solid tumours. Meanwhile, additional endpoints included clinical benefit rate, duration of response, progression-free survival and overall survival (OS).

After a follow-up of 19.2 months, the median OS with amivantamab treatment was 23 months (95%), with a two-year OS rate of 47%. Meanwhile, across subgroups, treatment with amivantamab resulted in consistent efficacy across post-platinum patients and 48 patients (42%) had sustained clinical response measured by ORR on amivantamab for at least 12 cycles.

Furthermore, no new safety signals were identified, while a rash remained the most common treatment-emergent adverse event.

Martin Vogel, EMEA therapeutic area lead for oncology at Janssen-Cilag GmbH, explained: “Despite treatment advances, patients with advanced NSCLC with EGFR exon 20 insertion mutations continue to face poor clinical outcomes.”

He added: “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.”

Pilar Garrido, associate professor of medical oncology at Universidad de Alcalá and principal investigator, reflected: “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.”