NEW YORK – Janssen on Monday said the Phase III PAPILLON clinical trial met its primary endpoint and showed that its monoclonal antibody Rybrevant (amivantamab) plus chemotherapy improved progression-free survival in newly diagnosed patients with advanced or metastatic non-small cell lung cancer bearing EGFR exon 20 insertion mutations compared to chemotherapy alone.
According to a company spokesperson, PAPILLON is a confirmatory study that supports the approved use of Rybrevant as a treatment for EGFR exon 20-altered advanced NSCLC cancer patients who have progressed on platinum-based chemo. The company will submit this data to the US Food and Drug Administration seeking full approval of the drug.
The FDA granted accelerated approval to single-agent Rybrevant in this setting in May 2021 and also approved Guardant Health's Guardant360 CDx test as a tool for identifying those with EGFR exon 20 insertion mutations who may be eligible for treatment. For that accelerated approval, the agency relied on data from the single-arm CHRYSALIS trial in 81 patients showing an overall response rate of 40 percent and a median duration of response of 11.1 months; 63 percent of patients responded to the combination regimen for more than six months.
Janssen touted PAPILLON as the first randomized study to demonstrate clinically meaningful results in this subset of patients. In the study, patients received either a combination of Rybrevant-chemo or chemo alone for up to four cycles. The primary endpoint in the trial was progression-free survival, and researchers also tracked objective response rate, duration of response, and overall survival as secondary endpoints.
According to Janssen, treatment with Rybrevant-chemo statistically significantly and clinically meaningfully improved patients' progression-free survival compared to those who received just chemo. The safety profile of the combination treatment was comparable to the safety profile of the individual treatment regimens. In addition to sharing data from PAPILLON with the FDA, Janssen plans to present the findings at an upcoming medical conference.