Abstract 1122P
Background
CHRYSALIS is an open-label, single arm phase 1b/2 clinical trial conducted to assess safety and efficacy of amivantamab in patients with EGFR Ex20ins advanced NSCLC, after progressing on platinum doublet chemotherapy (CT). In absence of a comparator arm in CHRYSALIS, comparison of trial outcomes versus an external cohort of similar patients allows to quantify clinical benefits relative to treatments used in current clinical practice.
Methods
Individual patient data for baseline risk factors and outcomes on OS, PFS and TTNT were available for patients from CHRYSALIS (median follow-up 12.5 m) and for a cohort of similar patients treated with real-world clinical practice (RWCP) from the Epidemio-Strategy and Medical Economics (ESME) advanced lung cancer database (NCT03848052). All treatment lines for patients fulfilling the CHRYSALIS eligibility criteria with at least 1 subsequent therapy after CT progression were selected from ESME. Comparative analyses were adjusted for imbalances on baseline characteristics, including number of prior treatment lines and metastatic sites, brain metastasis, liver metastasis, age, gender, smoking status and ECOG. Inverse probability weighting. Hazard ratios (HR) for amivantamab versus RWCP were estimated for OS, PFS and TTNT using IPW weighted proportional hazards regression. Multivariable regression including baseline characteristics as covariates was done as a confirmatory analysis.
Results
114 pts from CHRYSALIS and 52 treatment lines from 44 patients from ESME were included in the comparative analyses. Following adjustment, amivantamab was significantly superior to RWCP across all endpoints and methods. Table: 1122P
| Outcome | Amivantamab median [95% CI] | RWCPMedian [95% CI] | ATT-adjustment HR [95% CI] (p-value) | Covariate adjustment HR [95% CI] (p-value) |
| OS | 22.8 [17.5 – NE] | 13.0 [7.9 –17.3] | 0.49 [0.29 – 0.82] (p = 0.007) | 0.46 [0.25 – 0.83] (p = 0.011) |
| PFS | 6.9 [5.6 – 8.6] | 5.7 [2.8 –7.9] | 0.56 [0.37 – 0.85] (p < 0.001) | 0.46 [0.31 – 0.69] (p < 0.001) |
| TTNT | 12.4 [8.3 – 18.8] | 7.8[4.4 – 8.3] | 0.48 [0.32 – 0.72] (p < 0.001) | 0.41 [0.27 – 0.62] (p < 0.001) |
Conclusions
These findings suggest that amivantamab is an effective treatment option associated with significantly better OS, PFS, and TTNT for EGFR ex20ins advanced NSCLC compared with current clinical practice in France.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Unicancer.
Funding
The ESME AMLC data platform is funded by five industrial partners: AstraZeneca, Merck Sharp and Dohme, Bristol-Myers Squibb, Janssen and Amgen. The industrial partners does not have any input into database management. Unicancer manages the ESME database independently.
Disclosure
C. Chouaid: Financial Interests, Personal, Advisory Board: AZ, BI, GSK, Roche, Sanofi-Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Institutional, Funding: AZ, BI, GSK, Roche, Sanofi-Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen. N. Perualila: Financial Interests, Personal, Full or part-time Employment, I am a full-time employee of Janssen Pharmaceutica - Johnson and Johnson: Janssen Pharmaceutica NV. D. Debieuvre: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Janssen, Pfizer, Ose Immunotherapeutics, Novartis, Sanofi-Aventis, Amgen, Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Funding: Roche, AstraZeneca, Janssen, MSD, Pfizer, BMS, Lilly, Boehringer Ingelheim, GSK, Chugaï, Chiesi, Novartis, Takeda, Bayer, Sanofi-Aventis. X. Quantin: Financial Interests, Institutional, Invited Speaker: SANOFI; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Personal, Other, Educational support: AstraZeneca. J. Diels: Financial Interests, Personal, Full or part-time Employment, Employee Janssen EMEA Head of Market Access Analytics and modelling: Janssen; Financial Interests, Personal, Stocks/Shares, Holds JNJ shares: Janssen. N. Rahhali: Financial Interests, Personal, Full or part-time Employment, I am a full-time employee of Janssen-Cilag - Johnson & Johnson: Janssen Cilag; Financial Interests, Personal, Stocks/Shares, I am a Janssen-Cilag full-time employee: Janssen Cilag. R. Toueg: Other, Personal, Full or part-time Employment: Janssen Cilag. T. Filleron: Other, Consulting (compensated to my institution): Cellectis. All other authors have declared no conflicts of interest.