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EGFR Exon 20-Insertion NSCLC Population Sees PFS Benefit from Amivantamab/Chemotherapy (PAPILLON Trial)

*October 2023*

Take home message: Amivantamab in combination with chemotherapy showed significantly improved PFS and a higher response rate compared to chemotherapy alone in treatment-naive patients with advanced non-small-cell lung cancer harboring EGFR exon 20 insertions, demonstrating its efficacy as a first-line treatment.

The phase 3 PAPILLON trial (NCT04538664) resulted in superior progression-free survival (PFS) outcomes for the combination of amivantamab-vmjw (Rybrevant) and chemotherapy, with a median PFS of 11.4 months (95% CI, 9.8-13.7) vs 6.7 months (95% CI, 5.6-7.3) with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer (NSCLC), according to data presented at the 2023 ESMO Congress and simultaneously published in the New England Journal of Medicine.1,2

At a median follow-up of 14.9 months, the blinded independent central review (BICR)–assessed hazard ratio was 0.395 in favor of the combination (95% CI, 0.30-0.53; P <.0001). Consistent benefit was also seen by investigator assessment, with a median PFS of 12.9 months with the combination vs 6.9 months with chemotherapy alone (HR, 0.38; 95% CI, 0.29-0.51; P <.0001). The 12- and 18-month PFS rates with the combination were 48% and 31%, respectively, vs 13% and 3% with chemotherapy alone.

A trend toward improved overall survival (OS) with the combination was also seen (HR, 0.675; 95% CI, 0.42-1.09; P =.106). Median OS was not evaluable (NE; 95% CI, NE-NE) in the combination arm vs 24.4 months (95% CI, 22.1-NE) in the chemotherapy-alone arm. The 18- and 24-month OS rates in the combination arm were 74% and 72%, respectively, vs 68% and 54% with chemotherapy alone.

“Consistent PFS benefit [was seen] across predefined subgroups by blinded independent central review. Amivantamab/chemotherapy represents the new standard of care for first-line EGFR exon 20 insertion–mutated advanced NSCLC,” Nicolas Girard, MD, PhD, professor of respiratory medicine at Versailles Saint Quentin University, and professor and head of the Curie-Montsouris Thorax Institute at the Institut Curie in France, said in a presentation of the data.

Findings from the trial served as the basis for Janssen’s submission of a supplemental biologics license application to the FDA and a Type II extension of indication application to the European Medicines Agency seeking the expanded approval of amivantamab plus chemotherapy for this population. Read more.