Johnson & Johnson’s (J&J’s) Rybrevant (amivantamab-vmjw) plus chemotherapy has been linked to the longest median overall survival (OS) seen in a Phase III trial in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Ex20ins) mutations.
In the Phase III PAPILLON study (NCT04538664), patients treated with the bispecific antibody combination achieved a median OS of nearly three years (34.3 months), compared with 27.9 months for chemotherapy alone.
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The combination extended median OS by more than six months, despite 76% of eligible patients in the chemotherapy arm crossing over to second-line Rybrevant after disease progression.
According to J&J, this represents the longest reported median OS in this patient population, which is nearly twice the historical median.
A prespecified analysis accounting for crossover to Rybrevant in the chemotherapy arm showed a reduction in risk of death by 43%.
MedStar Georgetown University Hospital thoracic oncology director and trial investigator Dr Chul Kim said: “We’ve come a long way in treating EGFR Ex20ins-positive lung cancer, and these results demonstrate the lasting impact RYBREVANT plus chemotherapy can have in helping patients live longer. Patients are continuing treatment years after they started, which speaks to the durability of this approach and its value as a first-line treatment for this disease.”
The safety profile of IV Rybrevant remained consistent with previous studies, with the most common treatment-related adverse events (TEAEs) being paronychia, neutropenia and rash.
The data were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), taking place in Seoul, Republic of South Korea, from 12 to 15 September.
The OS data build on the primary PAPILLON analysis shared in October 2023, which demonstrated a statistically significant and clinically meaningful 60% improvement in progression-free survival (PFS), meeting the trial’s primary endpoint. Median PFS in the triplet arm of the trial was 11.4 months, while it was just 6.7 months in the doublet arm.
EGFR Ex20ins mutations account for approximately 12% of all EGFR mutations and have been historically difficult to treat with targeted medicines.
Historically, median OS has ranged from 16 to 24 months, with five-year survival reported at just 8%.
J&J gained approval for Rybrevant in patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and Ex20ins mutations, in the first- and second-line settings.
According to a GlobalData report, the NSCLC therapeutics market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) was valued at $24.1bn in 2022 and is forecast to reach $56.5bn by 2032, reflecting a CAGR of 8.9% during the forecast period.
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