Adjusted Comparison of Amivantamab in Combination With Carboplatin Plus Pemetrexed From the PAPILLON Study Versus US Real-World Frontline Treatments in Patients With Advanced NSCLC Harboring EFGR Exon 20 Insertions
Author(s)
Marcy Schaeffer, MPH, PhD1, Xiwu Lin, PhD2, Nick Ngo, PharmD, MBA3, Nolen joy Perualila, PhD1, Eduardo Quintero Caparros, MBA4, Francesca Galea Hales, BSc, MSc, PhD5, Annika Hultén, PhD6;
1Janssen Pharmaceutica N.V., Beerse, Belgium, 2Janssen Global Services, LLC, Horsham, PA, USA, 3Janssen Global Services, LLC, Raritan, NJ, USA, 4Janssen-Cilag SA, Madrid, Spain, 5Janssen-Cilag Ltd, High Wycombe, United Kingdom, 6Janssen-Cilag Oy, Espoo, Finland
1Janssen Pharmaceutica N.V., Beerse, Belgium, 2Janssen Global Services, LLC, Horsham, PA, USA, 3Janssen Global Services, LLC, Raritan, NJ, USA, 4Janssen-Cilag SA, Madrid, Spain, 5Janssen-Cilag Ltd, High Wycombe, United Kingdom, 6Janssen-Cilag Oy, Espoo, Finland
Presentation Documents
OBJECTIVES: In the Phase 3 PAPILLON trial, amivantamab in combination with carboplatin plus pemetrexed (ACP) demonstrated superior efficacy versus carboplatin plus pemetrexed (CP) as frontline treatment (1L) for patients with advanced NSCLC harboring activating EGFR exon 20 insertion (exon20ins). Until recently, although treatment guidelines recommended platinum doublet chemotherapy as 1L, real-world data has shown the use of several other treatment classes. This study aims to assess the comparative effectiveness of 1L ACP versus real-world treatments in the US.
METHODS: This study utilized data collected between 2012 and 2023 from 2 US databases (COTA NSCLC VANTAGE, ConcertAI Patient360 NSCLC) to create a real-world cohort. Patients aged 18 years or older with locally advanced/metastatic NSCLC, without prior systemic treatment, with ECOG PS 0-1 (when available), and confirmed exon20ins were included. Progression free survival (PFS), time to next treatment (TTNT), and overall survival (OS) of ACP from PAPILLON trial were compared to the pooled real-world physician choice (RWPC), using inverse probability weighting of the average treatment effect in the treated (IPW-ATT) adjustment for potential confounders.
RESULTS: A total of 94 real-world patients were obtained. Median follow-up was 50.5 months; 59.6% were female, 54.3% were over 65 years, 36.2% reported a history of smoking, 26.6% had liver metastases, and 33.0% had brain metastases. 1L treatments included platinum-based chemotherapy + immunotherapy (35.1%), EGFR TKI alone (25.5%), platinum-based chemotherapies (16.0%), immunotherapy alone (6.4%), or others (17.0%). Based on IPW-ATT adjustment, ACP showed statistically significant improvement vs pooled RWPC with HRs (95% CI) of 0.37 (0.25, 0.55), 0.34 (0.22, 0.52), and 0.43 (0.26, 0.70) for PFS, TTNT, and OS, respectively.
CONCLUSIONS: Building on the findings from the PAPILLON trial, the superior efficacy demonstrated by ACP compared to RWPC in this study further supports its adoption as the new standard of care for 1L patients with advanced NSCLC harboring EGFR exon20ins mutations.
METHODS: This study utilized data collected between 2012 and 2023 from 2 US databases (COTA NSCLC VANTAGE, ConcertAI Patient360 NSCLC) to create a real-world cohort. Patients aged 18 years or older with locally advanced/metastatic NSCLC, without prior systemic treatment, with ECOG PS 0-1 (when available), and confirmed exon20ins were included. Progression free survival (PFS), time to next treatment (TTNT), and overall survival (OS) of ACP from PAPILLON trial were compared to the pooled real-world physician choice (RWPC), using inverse probability weighting of the average treatment effect in the treated (IPW-ATT) adjustment for potential confounders.
RESULTS: A total of 94 real-world patients were obtained. Median follow-up was 50.5 months; 59.6% were female, 54.3% were over 65 years, 36.2% reported a history of smoking, 26.6% had liver metastases, and 33.0% had brain metastases. 1L treatments included platinum-based chemotherapy + immunotherapy (35.1%), EGFR TKI alone (25.5%), platinum-based chemotherapies (16.0%), immunotherapy alone (6.4%), or others (17.0%). Based on IPW-ATT adjustment, ACP showed statistically significant improvement vs pooled RWPC with HRs (95% CI) of 0.37 (0.25, 0.55), 0.34 (0.22, 0.52), and 0.43 (0.26, 0.70) for PFS, TTNT, and OS, respectively.
CONCLUSIONS: Building on the findings from the PAPILLON trial, the superior efficacy demonstrated by ACP compared to RWPC in this study further supports its adoption as the new standard of care for 1L patients with advanced NSCLC harboring EGFR exon20ins mutations.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO125
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology