Abstract 70P
Background
The treatment landscape for metastatic NSCLC with EGFR exon 20 insertion (Ex20ins) mutations is evolving rapidly, with the development of specific targeted therapies. In this report, we focused on patients receiving amivantamab in a pre-treated clinical setting from the Italian real-world registry ATLAS.
Methods
Patients with metastatic EGFR Ex20ins-mutated NSCLC treated with amivantamab after at least one prior line of therapy were included. Clinical-pathological features, treatment effectiveness and safety outcomes were retrospectively collected from the Italian ATLAS registry.
Results
The data of 64 NSCLC patients (pts) with EGFR Ex20ins, enrolled across 33 Italian centers were retrospectively analyzed. The median age was 64 years (range: 19–83). The majority of pts had an ECOG PS 0/1 (90.6%). Adenocarcinoma was the predominant histological subtype, accounting for 96.9% of cases. On average, pts had received one prior line of systemic therapy for metastatic disease (81.2% had received only one line). Common sites of metastasis included bone (43.7%), brain (35.9%), and liver (20.3%). The ORR was 37.5%, with a DCR of 66.2%. The mPFS for the overall cohort was 9.6 months (95% CI: 7.0–12.3), while the mOS was 16.9 months (95% CI: 13.9–19.9). In pts with brain metastases, the intracranial DCR was 56.5% (comprising a partial response in 13% and stable disease in 43.5%). Intracranial PFS was 11.6 months (95% CI: 4.6–18.6). Treatment-related AEs were generally mild and aligned with previous reports. The most frequent AEs included cutaneous toxicity (53.1%, with G33 in 7.8%), asthenia, IRRs and liver toxicity. Dose interruptions, reductions, and treatment discontinuations due to AEs occurred in 11 (17.1%), 7 (10.2%), and 2 (1.2%) pts, respectively.
Conclusions
These real-world data confirm the efficacy of amivantamab, as observed in the CHRYSALIS study, showing a meaningful clinical benefit in a heavily pretreated patient population, including those with brain metastases. Moreover, the safety profile of amivantamab was consistent with prior reports, showing manageable adverse events with appropriate management strategies.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Passaro: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer, Roche, Bayer; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme, Mundipharma, Daiichi Sankyo, Medscape, eCancer; Financial Interests, Personal and Institutional, Invited Speaker, Steering Committee Member PALOMA-3 trial: Janssen; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, Janssen, Cullinan Oncology; Financial Interests, Personal and Institutional, Invited Speaker: MSD, Arrivent, Bayer; Non-Financial Interests, Personal, Other, Scientific Commitee for Lung Cancer Guideline: AIOM; Non-Financial Interests, Personal, Officer, ESMO Council Member & Chair of Communication Committee: ESMO; Non-Financial Interests, Personal, Officer, Chair of Communication Committee: ESMO; Non-Financial Interests, Personal, Officer, Council Member: ESMO. G. Pasello: Financial Interests, Personal, Invited Speaker: Amgen, Eli Lilly, Novartis, MSD, Pfizer; Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, Janssen; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Other, unconditioned support: AstraZeneca, MSD; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, Roche, Novartis, Lilly, Janssen, PharmaMar. M. Tiseo: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Roche, Amgen, Takeda, MSD, Merck, BMS, Pfizer, Eli-Lilly, Novartis, Janssen, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, Roche. S. Novello: Financial Interests, Personal, Invited Speaker: AZ, MSD, Eli Lilly, Novartis, Beigene, Amgen, Thermo Fisher; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen, J&J; Financial Interests, Institutional, Invited Speaker, IIT: MSD, BI; Financial Interests, Institutional, Invited Speaker: AZ, AMG, Eli Lilly, Sanofi, J&J, Roche; Non-Financial Interests, Personal, Leadership Role, president of this European advocacy: WALCE; Non-Financial Interests, Personal, Member: IASLC, AIOM, ASCO. F. Passiglia: Financial Interests, Personal, Advisory Role: AstraZeneca, BMS, Novartis, Roche, MSD, Amgen, Johnson and Johnson, Sanofi, Beigene, Pharmastar, Pfizer, ThermoFisher Scientific. All other authors have declared no conflicts of interest.