NEW YORK – Janssen said on Monday that it has a filed supplemental biologics licensing application with the US Food and Drug Administration for Rybrevant (amivantamab) plus chemotherapy in certain advanced EGFR-mutated non-small cell lung cancer patients.
Based on data from the Phase III MARIPOSA-2 clinical trial, the drugmaker is seeking approval for Rybrevant plus chemo in NSCLC patients whose cancers have progressed following treatment with AstraZeneca's Tagrisso (osimertinib) and whose tumors harbor EGFR exon 19 deletions or EGFR L858R substitutions.
In MARIPOSA-2, Rybrevant plus chemo improved patients' progression-free survival compared to treatment with chemotherapy alone. Among patients who received the combination, the median progression-free survival was 6.3 months, whereas the median profession-free survival was 4.2 months with chemotherapy alone.
Of note, Janssen also designed MARIPOSA-2 with a third treatment arm, in which patients received a triplet treatment combination of Rybrevant, chemotherapy, and the EGFR tyrosine kinase inhibitor Leclaza (lazertinib). Although adding Leclaza delayed treatment progression even more — patients lived a median of 8.3 months without their cancers progressing on the triplet combination — oncologists noted in October that hematologic toxicities were significantly increased with the three-drug regimen and that the dose would need amending accordingly.
In 2021, the FDA granted accelerated approval to Rybrevant for EGFR exon 20-mutated NSCLC patients whose cancers progressed after chemotherapy. In August 2023, Janssen announced it was seeking FDA approval for Rybrevant plus chemo in the first-line setting, and the firm also filed an application for this upfront indication with European regulators last month.