Evaluating Treatment in High-Risk Lung Cancer Mutations and ctDNA
Alexander Spira, MD, PhD, FACP, discusses the PAPILLON trial, including its methods, design, and rationale as well as new data from the study.
Alexander Spira, MD, PhD, FACP, director of the Virginia Cancer Specialists Research Institute, discusses the PAPILLON trial (NCT04538664), including its methods, design, and rationale as well as new data from the study.
Amivantamab-vmjw (Rybrevant) was approved by the FDA in March 2024, for the treatment of patients with EGFR exon 20 insertion mutation-positive non–small cell lung cancer (NSCLC).1 Findings from the phase 3 PAPILLON trial supported this regulatory decision as amivantamab with carboplatin and pemetrexed showed a statistically significant improvement in progression-free survival (PFS) vs carboplatin and pemetrexed.
Transcription:
0:10 | This is a follow-up to the original PAPILLON study. So, the original study, which is now approved in the United States as well as outside the US in many places, was comparing the use of amivantamab, which targets EGFR MET, specifically in patients with this rare but prevalent EGFR exon 20 insertion mutation. The clinical study had already shown that the drug was approved in the second-line, and this is a very straightforward study to determine whether or not the addition of amivantamab to newly diagnosed patients, i.e., in the first-line setting, improved outcomes.
0:40 | That study has already been reported as a positive study and is now standard of care for most patients. The question, which was recently presented at WCLC, was trying to determine whether this works well in the bad actors. There are certain things we consider bad acting or bad acting mutations. Specifically, we looked at people who not only had exon 20, which was mandated, but also at what's called p53. If you had a p53 mutation, which is generally described as a negative prognostic factor, as well as positive circulating tumor DNA—meaning there was enough tumor present that it could be measured in the blood via circulating tumor DNA.
