Healthcare
In the PAPILLON Study, First-Line Amivantamab-Chemotherapy Demonstrates the Longest Overall Survival Reported for EGFR Exon 20 Insertion-Positive Advanced NSCLC
Results from the Phase III PAPILLON study show that first-line amivantamab plus carboplatin-pemetrexed (amivantamab-chemotherapy) was associated with numerically longer overall survival compared with chemotherapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Ex20ins) mutations. The findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).
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Final overall survival analysis reports median survival of 34.3 months with amivantamab-chemotherapy versus 27.9 months with chemotherapy SEOUL, Republic of Korea, Sept. 14, 2026 /PRNewswire/ -- Results from the Phase III PAPILLON study show that first-line amivantamab plus carboplatin-pemetrexed (amivantamab-chemotherapy) was associated with numerically longer overall survival compared with chemotherapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Ex20ins) mutations. The findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC). EGFR exon 20 insertions account for approximately 12% of EGFR-mutated NSCLC. In PAPILLON (NCT04538664), 308 participants with previously untreated Ex20ins advanced NSCLC were randomized 1:1 to amivantamab-chemotherapy (n=153) or chemotherapy (n=155). Participants in the chemotherapy arm were permitted to cross over to second-line amivantamab monotherapy after confirmed disease progression. Overall survival was a key secondary endpoint. At the March 20, 2026 data cutoff, with a median follow-up of 48.6 months, median overall survival was 34.3 months with amivantamab-chemotherapy versus 27.9 months with chemotherapy (HR 0.87; 95% CI, 0.66–1.14; P=0.307). This represents a numerical improvement of 6.4 months in median overall survival. Overall survival results generally favored amivantamab-chemotherapy across predefined subgroups. Among 128 participants in the chemotherapy arm who discontinued because of progressive disease, 97 (76%) received second-line amivantamab monotherapy. After adjusting for on-protocol crossover using the prespecified inverse probability of censoring weighting (IPCW) model, amivantamab-chemotherapy demonstrated a significant survival benefit (IPCW HR 0.57; 95% CI, 0.39–0.82; nominal P=0.003). The safety profile of intravenous amivantamab-chemotherapy was consistent with prior reports with intravenous amivantamab before subcutaneous amivantamab and prophylactic adverse event strategies were implemented. Patient-reported outcomes also favored amivantamab-chemotherapy, with prolonged time to worsening across several key symptom scales. "PAPILLON demonstrated the longest reported median overall survival to date in EGFR exon 20 insertion-positive advanced NSCLC with first-line amivantamab-chemotherapy," said Chul Kim, M.D., Division of Hematology and Oncology, Georgetown Cancer Institute, Washington, D.C. "While crossover likely attenuated the hazard-ratio-based overall survival estimate, the adjusted analysis showed a substantially longer estimated survival benefit, supporting amivantamab-chemotherapy as a foundational first-line regimen for patients with Ex20ins advanced NSCLC." About the IASLC The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information. About the WCLC The WCLC is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/ . Contact: Chris Martin, IASLC Media Relations, [email protected] View original content to download multimedia: https://www.prnewswire.com/news-releases/in-the-papillon-study-first-line-amivantamab-chemotherapy-demonstrates-the-longest-overall-survival-reported-for-egfr-exon-20-insertion-positive-advanced-nsclc-302877271.html