Abstract 100: Real-world clinical outcomes associated with first line treatments in patients with advanced non-small cell lung cancer without EGFR mutation or ALK rearrangement based on AACR GENIE
Authors: Kanakamedala Hemanth , Cai Beilei , Wirta Sara Bruce , Borker Rohit , Caro Nydia , Wu Wen-Hsing , Holynskyj Ariadna 
Published: July 2021

Abstract
Background Patients with locally advanced or metastatic non-small cell lung cancer (aNSCLC) have a poor prognosis, with a historic five-year overall survival (OS) of less than 10%. Patients with aNSCLC without common actionable oncogenic drivers such as EGFR mutations or ALK rearrangements are often limited to immunotherapy and/or chemotherapy, leaving a group of patients with unmet medical need. This study explored OS and progression-free survival based on radiographic imaging (PFS-I) among aNSCLC patients with EGFR wild type (wt) and ALK wt treated in real-world academic setting using AACR GENIE data.
Methods Data collected from 4 academic cancer centers in North America from AACR Project GENIE cancer registry was used for this study. The data included patients who underwent next-generation genomic sequencing (NGS) between 2014 and 2017 linked with clinical outcomes obtained during routine practice. Patients initially diagnosed with stage III or IV aNSCLC, underwent NGS prior to or within 60 days after starting their first line of therapy (LOT1), with NGS-confirmed ALK wt and EGFR wt were selected. Patients were then classified into four groups based on their LOT1 regimen: chemotherapy single agent or combinations (chemo), immunotherapy-monotherapy (IO), targeted therapy (TT), and bevacizumab plus chemo (bev+chemo). PFS-I and OS were measured from the start of LOT1 for each therapy group. As progression data were only available for stage IV patients in AACR GENIE, PFS-I was reported for this subgroup only. Baseline characteristics were not adjusted.
Results 263 patients satisfied criteria for inclusion in the study: 175 (67%), 31 (12%), 14 (5%), and 38 (14%) initiated chemo, IO, TT, and bev+chemo respectively. Of the 263 patients: 57% were female, mean age was 64, and 85% were current or former smoker. 99% of patients initiated LOT1 in year 2017 or earlier. 68%, 97%, 93%, and 100% were diagnosed with stage IV among chemo, IO, TT, and bev+chemo groups respectively. Median PFS-I (mPFS-I) in stage IV patients was 5.0 (confidence interval [CI]: 3.9-5.7) months, and median OS (mOS) in stage III/IV patients was 20.4 (CI:14.8-25.3) months. Among stage IV patients, mPFS-I by regimen group was 4.2 (CI:3.1-5.7), 4.0 (CI:1.4-7.1), 6.2 (CI:3.3-15.0), and 6.8 (CI:4.4-10.3) months for chemo, IO, TT, and bev+chemo respectively. Among stage III/IV patients, mOS by regimen group was 19.7 (CI:12.7-25.4), 18.4 (7.1-not reached [NR]), NR (CI:6.2-NR), and 23.5 (CI:10.3-35.1) months for chemo, IO monotherapy, TT, and bev+chemo respectively.
Conclusion This is the first study to assess outcomes among aNSCLC patients who are EGFR-wt and ALK-wt from the AACR Project GENIE registry. It provides a descriptive assessment of clinical outcomes associated with standard care treatment in the academic setting as more treatment options become available.
Citation Format: Hemanth Kanakamedala, Beilei Cai, Sara Bruce Wirta, Rohit Borker, Nydia Caro, Wen-Hsing Wu, Ariadna Holynskyj. Real-world clinical outcomes associated with first line treatments in patients with advanced non-small cell lung cancer without EGFR mutation or ALK rearrangement based on AACR GENIE [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 100.