Author(s)
Chouaid C1, Girard N2, Kron A3, Scheffler M3, Knott C4, Bosquet L5, Trigo J6, Viteri S7, Sebastian M8, Popat S9, Rahhali N10, Toueg R10, Rodrigues B11, Diels J12, Schioppa CA12, Cabrieto J12, Sermon J12, Perualila NJ12, Erdmann N13, Mielke J13, Nematian-Samani M13, Pfaira I14, Martin-Fernandez C14, Mahadevia P15, Li T15, Pick-Lauer C13, Adamczyk A16, Penton J14, Wolf J3
1Service de Pneumologie, Pneumology, Intercommunal Hospital, Créteil, France, 2Institut Curie, Paris, France, 3Lung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany, 4Health Data Insight CIC, Cambridge, UK, 5Health Data and Partnerships Department, Unicancer, Paris, France, 6Hospital Universitario Virgen de la Victoria y Regional, IBIMA, Malaga, Spain, 7UOMI Cancer Center, Clínica Mi Tres Torres, Barcelona, Spain, 8Department of Medicine, Hematology and Oncology, University of Frankfurt, Frankfurt, Germany, 9The Royal Marsden Hospital, London, UK, 10Janssen Cilag, Île-de-France, France, 11Janssen Cilag, Porto Salvo, Portugal, 12Janssen Pharmaceutica NV, Beerse, Belgium, 13Janssen-Cilag GmbH, Neuss, Germany, 14Janssen-Cilag Ltd, High Wycombe, UK, 15Janssen R&D, Raritan, NJ, USA, 16Janssen Cilag, Madrid, Spain
OBJECTIVES: Amivantamab demonstrated efficacy and tolerability in patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations (Exon20ins) in the phase 1/2 CHRYSALIS trial (NCT02609776), resulting in regulatory approvals. CHRYSALIS was single-arm; thus, comparative data are required to evaluate relative effectiveness versus real-world clinical practice (RWCP) for this patient population with high unmet need. METHODS: Real-world patient data from Europe and the US were obtained from chart reviews (retrospective) and registries (retrospective and prospective) for patients with EGFR Exon20ins NSCLC following platinum-based therapy. Given the rarity of Exon20ins, RWCP sources were pooled for comparison with amivantamab data from CHRYSALIS (N=114). The following endpoints were assessed: overall response rate (ORR; investigator-assessed [INV]; RWCP: N=268), progression-free survival (PFS; INV; RWCP: N=443), time-to-next treatment (TTNT; RWCP: N=456) and overall survival (OS; RWCP: N=456). All eligible RWCP treatment lines within the same patient were used. Differences in patient and disease characteristics were adjusted for using inverse probability weighting (average treatment effect among the treated). RESULTS: After adjustment, baseline characteristics were well-balanced between cohorts (average standardised mean difference: ≤0.25). Predicted response for ORR was 36.8% (95% CI: 28.5%, 46.0%) versus 17.2% (13.1%, 22.2%) for amivantamab versus adjusted RWCP, respectively (response-rate ratio: 2.14 [1.50, 3.06]; p<0.0001). Median PFS, OS and TTNT were 6.93 (5.55, 8.64) versus 4.14 (3.15, 4.86) months (hazard ratio [HR]: 0.54 [0.43, 0.69]; p<0.0001), 22.77 (17.48, non-estimable) versus 12.35 (10.68, 13.70) months (HR: 0.46 [0.33, 0.64]; p<0.0001) and 12.42 (8.34, 18.79) versus 5.52 (4.83, 6.28) months (HR: 0.44 [0.34, 0.57]; p<0.0001) for amivantamab versus adjusted RWCP, respectively. Results were consistent across geographies and when using independent review committee assessment data. CONCLUSIONS: Adjusted comparisons demonstrate a statistically significant clinical benefit for amivantamab versus RWCP, highlighting the value of amivantamab for addressing the unmet need in advanced EGFR Exon20ins NSCLC.
Conference/Value in Health Info
2022-11, ISPOR Europe 2022, Vienna, Austria
Value in Health, Volume 25, Issue 12S (December 2022)
Code
CO73
Topic
Clinical Outcomes, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy, Electronic Medical & Health Records, Health & Insurance Records Systems, Meta-Analysis & Indirect Comparisons
Disease
SDC: Oncology