Abstract 1200P
Background
Brigatinib is a next-generation ALK inhibitor (ALKi) approved in ALK+ advanced NSCLC (aNSCLC) pretreated with crizotinib and in first-line setting. The objective of BrigALK study was to assess efficacy of brigatinib during the French early access program (FEAP).
Methods
BrigALK study retrospectively included ALK+ aNSCLC pretreated with at least one ALKi during brigatinib FEAP. Primary endpoint was investigator-assessed progression-free survival (invPFS). BrigALK2 covered the entire EAP period and was an update of abstract 1392P presented at ESMO 2020 with a longer follow-up and a focus on lorlatinib efficacy after brigatinib.
Results
183 patients were included by 66 centers in France: median age: 60 ±12.7 years; never smokers: 78.3%; median number of previous lines: 3 ±1.3 and of ALKi: 2 ±0.5. 68.1% of patients had performance status 0-1 and 55.6 % more than 3 metastatic sites. With a median follow up of 40.5 (95%CI 38.4-42.4) months, median invPFS was 7.4 (95% CI: 5.9-9.6) months. Median duration of brigatinib treatment was 7.4 (95% CI 5.3-8.3) months. Median OS from brigatinib initiation was 20.3 months (95%CI: 15.6-27.6). For patients who received 1 (n=23), 2 (n=146) or 3 (n= 14) ALKi before brigatinib, median duration of treatment was 13.8 (95%CI 3.8-26.4), 7.4 (95%CI 5.6-9.9) and 4.9 (95%CI 1.7-9.3) months, respectively and median OS from brigatinib initiation was 24.3 (95%CI 9.7-NR), 20.3 (95%CI 16.2-28.7) and 18.1 (95%CI 3.3-34.5) months, respectively. 92 (50%) patients received at least 1 post-brigatinib treatment. 68 (73.9%) were treated with lorlatinib: 51 (75%) immediately after brigatinib, 12 (17.6%) after 1 subsequent treatment, 5 (7.4%) after at least 2 subsequent treatments. With a median follow-up of 29.9 (25.7-33.1) months, median duration of lorlatinib treatment was 5.3 (95% CI 3.6-7.6) months and median OS from lorlatinib initiation was 14.1 (95%CI 10.3-19.2) months.
Conclusions
The analysis of the EAP confirms the effectiveness of brigatinib in a cohort of heavily pretreated ALK-positive aNSCLC patients and the activity of subsequent ALKi after brigatinib.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
GFPC: Groupe Français de Pneumo-Cancérologie (French Lung Cancer Group).
Funding
Takeda.
Disclosure
R. Descourt: Financial Interests, Personal, Invited Speaker, advisory board: Takeda; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker, advisory board: Roche; Financial Interests, Personal, Invited Speaker: Novartis. M. Pérol: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal and Institutional, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Institutional, Funding: Chugai. G. Rousseau-Bussac: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Takeda. B. Mennecier: Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Institutional, Principal Investigator: Takeda. M. Wislez: Non-Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Roche; Non-Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Personal, Speaker’s Bureau: BMS; Non-Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Personal, Advisory Board: MSD; Non-Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Non-Financial Interests, Institutional, Principal Investigator: Lilly; Non-Financial Interests, Institutional, Principal Investigator: Merck KGaA; Non-Financial Interests, Institutional, Principal Investigator: Merus; Non-Financial Interests, Institutional, Principal Investigator: GSK; Non-Financial Interests, Institutional, Principal Investigator: Amgen; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim. J. Cadranel: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Novartis. A.B. Cortot: Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: BMS; Non-Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Personal, Advisory Board: MSD; Non-Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Non-Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Personal, Advisory Board: Takeda; Non-Financial Interests, Institutional, Principal Investigator: Takeda; Financial Interests, Personal, Advisory Board: Roche; Non-Financial Interests, Institutional, Principal Investigator: Roche. F. Guisier: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: AstraZeneca. R. Schott: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: BMS. J. Arrondeau: Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS. J.B. Auliac: Financial Interests, Personal, Invited Speaker, consulting: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker, consulting: F. Hoffman-Roche; Financial Interests, Personal, Invited Speaker, consulting: Lilly; Financial Interests, Personal, Invited Speaker, consulting: Pfizer. C. Chouaid: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi-Aventis; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Amgen. All other authors have declared no conflicts of interest.