Patients with advanced lung cancer carrying EGFR exon 20 insertions had median overall survival of 34.3 months with J&J’s RYBREVANT plus chemotherapy in PAPILLON, versus 27.9 months with chemotherapy alone; the final analysis was not statistically significant.
The protocol-specified final analysis had a hazard ratio of 0.87 (95% confidence interval, 0.66–1.14; P=0.307). A prespecified analysis accounting for crossover found a 43% reduction in death risk (HR 0.57); after progression, 76% of eligible patients assigned to chemotherapy crossed over to RYBREVANT.
Progression-free survival through a second disease progression (PFS2) was 28.3 months with the combination versus 17.5 months with chemotherapy. Earlier progression-free-survival results supported global approvals in this setting. J&J reported no new safety signals with longer follow-up; treatment-related paronychia and neutropenia each occurred in 60% of patients, and rash in 58%.
