Johnson & Johnson Touts Rybrevant Label Expansion After Rare Lung Cancer Approval

Janssen, a unit of Johnson & Johnson JNJ, announced preliminary data from the Phase 1 CHRYSALIS study evaluating Rybrevant (amivantamab-vmjw) for non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.
A total of 19 patients with METex14 mutations received either a high or low dose of Rybrevant, and 14 of them were evaluable. Of that 14 patients, partial responses were observed in 64%, with four patients pending confirmation.
The responses were seen in both patients who had and hadn’t received prior treatment, and the median time to first response was 4.1 months.
Three patients experienced serious side effects of the treatment, including difficulty breathing, hypoalbuminemia (a deficit of albumin in the blood), and rash.
About 5% of patients discontinued the treatment due to side effects.
In May, regulators gave Rybrevant an accelerated thumbs-up for a rare form of lung cancer, making it the first drug approved to treat patients with EGFR exon 20 insertion mutations.
Related content: Benzinga's Full FDA Calendar.
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