Janssen Announces Positive Phase III PAPILLON Trial Results for Amivantamab-vmjw in First-Line EGFR Exon20ins-Mutated NSCLC

On July 17, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced positive results from the Phase III PAPILLON study of amivantamab-vmjw (Rybrevant) in treating newly diagnosed EGFR exon 20 insertion mutation-positive advanced or metastatic non-small cell lung cancer (NSCLC) patients, meeting the primary endpoint of progression-free survival (PFS).

The press release shows that this is the first Phase III clinical trial to demonstrate clinically meaningful results compared to standard care in the population with EGFR exon 20 insertion mutations.

The PAPILLON study is a randomized, open-label Phase III clinical trial designed to evaluate the efficacy and safety of amivantamab-vmjw in combination with chemotherapy compared to chemotherapy alone in patients with newly diagnosed EGFR exon 20 insertion mutations in advanced or metastatic NSCLC. The primary endpoint is PFS assessed by BIRC according to RECIST v1.1, and secondary endpoints include overall response rate (ORR), PFS after the first subsequent treatment, time to symptom progression, and overall survival (OS).

Results Show the Study Met Its Primary Endpoint. Compared with chemotherapy alone, patients receiving amivantamab-vmjw + chemotherapy experienced a statistically significant and clinically meaningful improvement in PFS, with consistent safety. Johnson & Johnson will present detailed results at upcoming medical conferences.

Amivantamab-vmjw is a bispecific antibody that targets EGFR resistance mutations, MET mutations, and amplifications. It can simultaneously bind to the extracellular domains of EGFR and c-Met, block ligand binding to EGFR and MET, promote receptor degradation, and trigger antibody-dependent cellular cytotoxicity.

In May 2021, the FDA granted accelerated approval to amivantamab-vmjw for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is the first drug approved by the FDA targeting EGFR exon 20 insertion mutations.

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