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Janssen Seeks EU Approval for Amivantamab in Lung Cancer

NEW YORK – Janssen said on Monday it is seeking approval from the European Medicines Agency for amivantamab as a treatment for metastatic non-small cell lung cancer patients with EGFR exon 20 insertion mutations.

Amivantamab is an EGFR-MET bispecific antibody which targets and inhibits activating and resistance-driving mutations in the EGFR and cMET signaling pathways. The company submitted data from the Phase I CHRYSALIS study, in which researchers evaluated amivantamab alone in NSCLC patients, as well as in combination with lazertinib, a next-generation EGFR inhibitor Janssen is developing with Yuhan Corporation that targets activating EGFR and T790M resistance mutations.

According to data presented at the American Society of Clinical Oncology annual meeting this year, among 39 evaluable patients with EGFR exon 20 insertion mutations treated with amivantamab monotherapy in the CHRYSALIS study, the overall response rate was 36 percent. Among the 29 patients who had prior platinum-based chemotherapy, the overall response rate on amivantamab was 41 percent. The median duration of response was 10 months for all response-evaluable patients and 7 months for patients who received prior chemotherapy. Median progression-free survival was 8.3 months for all response-evaluable patients and 8.6 months for chemotherapy-treated patients.

"Despite advances in treatment, there is still a high unmet need amongst patients with EGFR-mutated NSCLC, particularly in the exon 20 insertion mutation population due to poor response to treatments that work for other mutations," Joaquín Casariego, oncology therapeutic area lead for Europe, Middle East, and Africa at Janssen-Cilag, said in a statement. "We are encouraged by the promising results of amivantamab which continue to demonstrate potential for providing a new treatment option for patients with advanced NSCLC with EGFR exon 20 insertion mutations."

This application marks the first regulatory submission in the EU for a NSCLC treatment specifically targeting EGFR exon 20 insertion mutations. Earlier this month, Janssen also submitted an application to the US Food and Drug Administration seeking approval for amivantamab in the same indication.