Abstract 89P
Background
This study describes clinical characteristics, treatment (Tx) patterns, and outcomes in patients (pts) with ALK+ advanced NSCLC (aNSCLC) treated with first-line (1L) brigatinib (BRG) in Germany, the UK, or the US in a real-world (rw) setting.
Methods
Data were derived from the Adelphi NSCLC Disease Specific Programme™, which is a large, multinational, observational study. Physicians (n=104) provided information for pts with ALK+ aNSCLC treated with 1L BRG. Clinical characteristics, Tx patterns, and outcomes were reported via an online form. First subsequent Tx (2L) post 1L BRG, tumor response rate, and rw time to Tx discontinuation (rwTTD) and time to progression (rwTTP) of 1L BRG were evaluated.
Results
Records were available for 331 pts treated with 1L BRG in Germany (n=100), UK (n=124), or US (n=107). Mean (SD) age was 63.7 y (9.2); 82% of pts were white, 54% male, 87% had NSCLC with adenocarcinoma histology; and 80% had ECOG performance score 0–1 at start of 1L BRG. Mean (SD) time from aNSCLC diagnosis to data collection was 16.7 mo (7.8). Among pts who received 2L Tx (n=58), 34% received lorlatinib, 17% received brigatinib, 12% atezolizumab, 9% crizotinib, and 7% alectinib. Sixty-four (19%) pts received radiotherapy (RT) concurrently with 1L BRG, with lymph nodes (41%) and bone (27%) the most common anatomical sites for RT. The majority (90%) reached an optimal dose of 180 mg/d. Most pts did not have 1L BRG dose interruption (87%) or change of dose (92%). The most common events on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO CTCAE) during 1L BRG treatment were gastrointestinal toxicities (64%, 34/53), including nausea (77%, 26/34), vomiting (56%, 19/34) and diarrhea (56%, 19/34). The rw overall response and disease control rates on 1L BRG were 83% and 91%, respectively. Median (95% CI) rwTTD and rwTTP of 1L BRG were 26.0 mo (23.2–32.0) and 29.0 mo (27.2–NR), respectively.
Conclusions
In pts with ALK+ aNSCLC, these rw outcomes indicated activity of 1L BRG, mirroring the phase III ALTA-1L data. The low frequency of dose interruptions and high dose compliance rate highlight BRG tolerability.
Editorial acknowledgement
Medical writing support for the development of this abstract, under the direction of the authors, was provided by Lauren Gallagher, RPh, PhD, of Peloton Advantage, LLC, an OPEN Health company.
Legal entity responsible for the study
Takeda Development Center Americas, Inc.
Funding
Takeda Development Center Americas, Inc.
Disclosure
S. Ghosh: Financial Interests, Personal, Advisory Role: AstraZeneca, Chugai, Merck Sharp & Dohme, Pfizer, Roche, Takeda. C. Kim: Financial Interests, Personal, Advisory Board: Arcus, AstraZeneca, Daiichi Sankyo, Eisai, Regeneron, Sanofi, Takeda, J&J, Pinetree; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Novartis, Regeneron, Janssen, Genentech, Lyell, Daiichi Sankyo, Gilead, Macrogenics, Boehringer Ingelheim, Black Diamond Therapeutics. H. Bailey: Financial Interests, Personal, Full or part-time Employment: Adelphi Real World. C. Forshaw: Financial Interests, Personal, Full or part-time Employment: Adelphi Real World. Y. Wan, M. Lin, J. Kretz: Financial Interests, Personal, Full or part-time Employment: Takeda. M. Metzenmacher: Financial Interests, Personal, Funding: Takeda; Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, BMS, GSK, Janssen, MSD, Novocure, Sanofi, Takeda, Roche, Pfizer.