The treatment combination of Rybrevant (amivantamab-vmjw) and chemotherapy has been shown to significantly improve progression-free survival in patients newly diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, according to a press release from Johnson & Johnson.
Rybrevant (amivantamab-vmjw) is an injectable drug that was approved by the Food and Drug Administration (FDA) in May 2021 to treat patients with NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The drug also previously demonstrated its efficacy for patients with NSCLC and EGFR exon 20 insertion mutations, and has now shown more improvements in combination with platinum-based chemotherapy, as the press release stated.
In the phase 3 PAPILLON study, which evaluated the combination of Rybrevant and chemotherapy, patients newly diagnosed with NSCLC with EGFR exon 20 insertion mutations demonstrated positive results from the treatment combination, according to the press release.
The study also met its primary endpoint (main result that measures a treatment’s efficacy in a study), in which the rate of progression-free survival (PFS, the period during and after treatment of cancer when the disease does not get worse) significantly improved when the combination of Rybrevant and chemotherapy was administered, compared with chemotherapy alone.
PAPILLION, with 308 participants, launched in 2020, according to its listing on clinicaltrials.gov. The study is currently estimated to be completed in January 2025. The July 17 press release detailing the study’s topline results stated that secondary endpoints for the study include overall response rate (ORR, percentage of the treatment group who have a partial or complete response to treatment within a given period), PFS following the first subsequent therapy, time to symptomatic progression and overall survival (OS, the period from diagnosis or treatment where patients are still alive).
READ MORE: Rybrevant Is Efficacious, Tolerable in EGFR Exon 20-Mutant Lung Cancer
“The results from the PAPILLON study support the efficacy of Rybrevant plus chemotherapy in the treatment of patients with non-small cell lung cancer with exon 20 insertion mutations,” said Dr. Peter Lebowitz, global therapeutic area head of oncology at Janssen Research & Development, LLC., in the press release. “Rybrevant was the first therapy approved in the relapsed/refractory setting for patients with EGFR exon 20 insertion mutations, a population that continues to experience persistent unmet medical needs. This phase 3 study is the first of several ongoing pivotal programs to read out evaluating Rybrevant-based regimens in patients with EGFR-mutated non-small cell lung cancer.”
Rybrevant is subject to several other current trials for patients with NSCLC, as Johnson & Johnson explained in its press release. A phase 3 study, MARIPOSA, is analyzing the combination of Rybrevant and Leclaza (lazertinib, a third-generation EGFR tyrosine kinase inhibitor to treat NSCLC), compared with the medications Tagrisso and Lecalza respectively taken alone. Furthermore, a phase 1 study, CHRYSALIS, is evaluating Rybrevant in patients with advanced NSCLC.
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