Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) has been approved by the US Food and Drug Administration (FDA) to treat a subset of non-small lung cancer (NSCLC) patients.
The bispecific antibody is now approved for use alongside carboplatin and pemetrexed chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Rybrevant has also been granted traditional approval to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, upgrading the FDA’s May 2021 accelerated approval for the drug in this indication.
NSCLC accounts for up to 85% of all lung cancer cases worldwide and alterations in EGFR are the most common actionable driver mutations in NSCLC.
Patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy, J&J said, adding that this patient population faces poorer prognosis and shorter survival rates compared with lung cancer patients with other EGFR driver mutations.
The FDA’s latest decisions on the drug are supported by positive results from the late-stage PAPILLON study, in which Rybrevant plus chemotherapy was associated with a 61% reduction in the risk of disease progression or death compared to chemotherapy alone.
Results also showed treatment with Rybrevant plus chemotherapy improved objective response rate and progression-free survival.
“The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients,” said study investigator Joshua Sabari, oncologist at NYU Langone’s Perlmutter Cancer Center.
The results from PAPILLON also supported the National Comprehensive Cancer Network’s decision to update its clinical practice guidelines to include a category one recommendation for Rybrevant plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.
Kiran Patel, vice president, clinical development, solid tumours, J&J Innovative Medicine. “Rybrevant plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
“We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio.”