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J&J Seeking Frontline Rybrevant-Lazertinib FDA Approval in EGFR-Mutated NSCLC

NEW YORK – Johnson & Johnson said on Thursday that it has filed an application with the US Food and Drug Administration seeking approval for Rybrevant (amivantamab) plus lazertinib as a frontline treatment for advanced, EGFR-mutated non-small cell lung cancer.

The drugmaker submitted a supplemental biologics license application for Rybrevant and a new drug application for lazertinib, which is approved in Korea under the brand name Leclaza but has not been approved in the US. J&J is hoping to garner US marketing authorization for the dual anti-EGFR regimen for NSCLC patients whose tumors harbor EGFR exon 18 deletions or EGFR L858R substitution mutations, as determined by an FDA-approved test.

The company's application contains data from the Phase III MARIPOSA study in which frontline treatment with J&J's EGFR-MET bispecific antibody Rybrevant, added to its EGFR inhibitor lazertinib, improved patients' progression-free survival versus AstraZeneca's EGFR inhibitor Tagrisso (osimertinib). In the trial, patients were randomly assigned to one of three treatments: Rybrevant and Leclaza; just lazertinib; or just Tagrisso.

Patients who received first-line Rybrevant-lazertinib had a median progression-free survival of 23.7 months compared to 16.6 months on Tagrisso alone. Progression-free survival on lazertinib monotherapy was similar to progression-free survival on Tagrisso monotherapy.

Rybrevant already has accelerated approval in the US for locally advanced or metastatic EGFR exon 20-mutated NSCLC patients who've received prior chemotherapy.

J&J subsidiary Janssen Pharmaceuticals is developing lazertinib with South Korean drugmaker Yuhan. The agent is approved in the Republic of Korea for patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have previously gotten another EGFR tyrosine kinase inhibitor. 

J&J said in October that it has filed an application seeking approval from European regulators for Rybrevant plus chemo in the upfront EGFR-mutated NSCLC setting.

Last month, J&J also filed an application with the FDA seeking approval for Rybrevant plus chemo for EGFR-mutated NSCLC patients who previously received Tagrisso. That application is based on data from the Phase III MARIPOSA-2 trial in which Rybrevant plus chemo improved patients' progression-free survival versus chemotherapy alone.